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A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation (IMbrave050)

Primary Purpose

Carcinoma, Hepatocellular

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Bevacizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only) within 4-12 weeks prior to randomization
  • Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA only)
  • Absence of major macrovascular invasion (except Vp1/Vp2) and extrahepatic spread
  • Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following curative procedure
  • Full recovery from surgical resection or ablation within 4 weeks prior to randomization
  • High risk for HCC recurrence after resection or ablation
  • For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
  • For patients with resected HCC, availability of a representative baseline tumor tissue sample
  • ECOG Performance Status of 0 or 1
  • Child-Pugh Class A status
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Evidence of residual, recurrent, or metastatic disease at randomization
  • Clinically significant ascites
  • History of hepatic encephalopathy
  • Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
  • Have received more than 1 cycle of adjuvant TACE following surgical resection
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Active tuberculosis
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to Day 1 of Cycle 1.
  • Co-infection with HBV and HCV
  • Co-infection with HBV and hepatitis D viral infection
  • Clinical significant uncontrolled or symptomatic hypercalcemia
  • Any treatment for HCC prior to resection or ablation, including systemic therapy and locoregional therapy such as TACE
  • Treatment with systemic immunostimulatory or immunosuppressive agents
  • Inadequately controlled arterial hypertension
  • History of hypertensive crisis or hypertensive encephalopathy
  • Significant vascular disease
  • Evidence of bleeding diathesis or significant coagulopathy
  • Current or recent use of aspirin or full-dose oral or parenteral anticoagulants
  • Core biopsy within 3 days of Day 1 of Cycle 1
  • History of GI fistula, GI perforation, or intra-abdominal abscess
  • Serious non-healing or dehiscing wound
  • Major surgical procedure within four weeks
  • Chronic daily treatment with a non-steroidal anti-inflammatory drug

Sites / Locations

  • Kaiser Permanente Los Angeles
  • Mercy Medical Center
  • Henry Ford Health System
  • Columbia University Medical Center
  • Thomas Jefferson University
  • The University of Texas Southwestern Medical Center at Dallas
  • MD Anderson Cancer Center
  • Swedish Cancer Inst.
  • St Vincent's Hospital Sydney
  • Riverina Cancer Care Centre
  • Lkh-Univ. Klinikum Graz
  • Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
  • Imeldaziekenhuis
  • AZ Delta (Campus Rumbeke)
  • Hospital Sao Rafael - HSR
  • Sociedade beneficente de senhoras Hospital Sirio Libanes
  • Hospital do Cancer UOPECCAN; Pesquisa Clínica
  • Hospital das Clinicas - UFRGS
  • Hospital Alemao Oswaldo Cruz; Oncologia
  • Gordon & Leslie Diamond Health Care Centre
  • McGill University Health Centre - Glen Site
  • Peking Union Medical College Hospital
  • Beijing Cancer Hospital
  • Affiliated Hospital of Bengbu Medical College
  • The First Hospital of Jilin University
  • West China Hospital, Sichuan University
  • Daping Hospital of Third Military Medical University
  • The Second Affiliated Hospital of Dalian Medical University
  • Mengchao Hepatobiliary Hospital Of Fujian Medical University
  • Fujian Cancer Hospital
  • Sun Yet-sen University Cancer Center
  • Cancer Center of Guangzhou Medical University
  • Zhujiang Hospital, Southern Medical University
  • Nanfang Hospital, Southern Medical University
  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
  • Harbin Medical University Cancer Hospital
  • Anhui Province Cancer Hospital
  • Anhui Provincial Hospital
  • The Second Affiliated Hospital of Anhui Medical University
  • Shandong Cancer Hospital
  • The 81st Hospital of P.L.A.
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Zhongda Hospital Affiliated to Southeast University
  • Guangxi Cancer Hospital of Guangxi Medical University
  • The First Affiliate Hospital of Guangxi Medical University
  • Zhongshan Hospital Fudan Unvierstiy
  • Huashan Hospital Affiliated to Fudan University
  • Fudan University Shanghai Cancer Center
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • The First Affiliated Hospital of China Medical University
  • Shengjing Hospital of China Medical University
  • Tianjin Cancer Hospital
  • The Tumor Hospital of Xinjiang Medical University
  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • Renmin Hospital of Wuhan University
  • Zhongnan Hospital of Wuhan University
  • Hubei Cancer Hospital
  • Northern Jangsu People's Hospital
  • Clinica CIMCA
  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
  • Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
  • Hopital Jean Minoz; Oncologie
  • Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis; Service d'Hépatologie
  • Hôpital Albert Michallon
  • Fondation Hopital Saint Joseph; Gastro-Enterologie
  • CHU Bordeaux - Hôpital Haut-Lévêque; Service d?Hépato-Gastroentérologie et d Oncologie digestive
  • Hopital Robert Debre; Gastro Enterologie
  • Hopital de Pontchaillou; Service Hepato Gastro Enterologie
  • CHU de Toulouse - Hôpital Rangueil
  • Hopitaux de Brabois - Gastro-Entereologie
  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.; Onkologische Gastroenterologie
  • Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
  • Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
  • Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
  • Queen Mary Hospital; Dept. Of Haematology & Oncology
  • Prince of Wales Hospital; Department of Clinical Onocology
  • Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
  • Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica
  • Asst Santi Paolo E Carlo
  • Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
  • Chiba University Hospital
  • Ehime Prefectural Central Hospital
  • Hiroshima University Hospital
  • Sapporo Kosei Genaral Hospital
  • Hyogo Medical University Hospital
  • Japanese Red Cross Society Himeji Hospital
  • Kanazawa University Hospital
  • Yokohama City University Medical Center
  • Kanagawa Cancer Center
  • Kitasato University Hospital
  • Kumamoto University Hospital
  • Osaka Red Cross Hospital
  • Kindai University Hospital
  • Tokushima University Hospital
  • Toranomon Hospital
  • The University of Tokyo Hospital
  • Japanese Red Cross Musashino Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • CHA Bundang Medical Center
  • Ajou University Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Seoul St Mary's Hospital
  • Borame Medical Center
  • Samsung Medical Center
  • Ulsan University Hosiptal
  • Centro Medico Dalinde
  • Filios Alta Medicina
  • Oaxaca Site Management Organization
  • Maastricht University Medical Center
  • Auckland City Hospital
  • Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
  • Instituto Nacional de Enfermedades Neoplasicas
  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Onkologii i Radioterapii,
  • First Moscow State Medical University n.a. I.M. Sechenov
  • Group of companies "Medci"
  • Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency
  • Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
  • National Cancer Centre
  • Tan Tock Seng Hospital; Oncology
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario Infanta Cristina; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Changhua Christian Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Taiwan Uni Hospital; Dept of Oncology
  • Taipei Veterans General Hospital; Gastroenterology Division
  • Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
  • Rajavithi Hospital; Division of Medical Oncology
  • Siriraj Hospital; Medical Oncology Unit
  • Chiang Rai Prachanukroh Hospital; Department Of Medicine
  • Chulabhorn Hospital; Medical Oncology
  • Adana Baskent University Hospital; Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A (atezolizumab plus bevacizumab)

Arm B (active surveillance)

Arm Description

Participants will receive Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.

Active surveillance of participants.

Outcomes

Primary Outcome Measures

Recurrence-Free Survival (RFS), as Determined by IRF
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
RFS as Determined by the Investigator
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an investigator, or death from any cause (whichever occurs first).
Time to Recurrence (TTR)
TTR defined as the time from randomization to first documented occurrence of intrahepatic or extrahepatic HCC, as determined by the investigator and by an IRF.
RFS Rate at 24 and 36 Months, as Assessed by the IRF
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
OS Rate at 24 and 36 Months
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
Time to Extrahepatic Spread (EHS) or Macrovascular Invasion
Time to EHS or macrovascular invasion after randomization, defined as the time from randomization to the first appearance of EHS or macrovascular invasion, as determined by the investigator.
RFS in Pd-L1-High Subgroup
RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup.
Percentage of Participants With Adverse Events
Serum Concentration of Atezolizumab
Number of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab

Full Information

First Posted
September 23, 2019
Last Updated
August 3, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04102098
Brief Title
A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
Acronym
IMbrave050
Official Title
A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
October 21, 2022 (Actual)
Study Completion Date
July 16, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
668 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (atezolizumab plus bevacizumab)
Arm Type
Experimental
Arm Description
Participants will receive Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
Arm Title
Arm B (active surveillance)
Arm Type
No Intervention
Arm Description
Active surveillance of participants.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS), as Determined by IRF
Description
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).
Time Frame
Baseline up to approximately 39 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Baseline up to approximately 91 months
Title
RFS as Determined by the Investigator
Description
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an investigator, or death from any cause (whichever occurs first).
Time Frame
Baseline up to approximately 91 months
Title
Time to Recurrence (TTR)
Description
TTR defined as the time from randomization to first documented occurrence of intrahepatic or extrahepatic HCC, as determined by the investigator and by an IRF.
Time Frame
Baseline up to approximately 91 months
Title
RFS Rate at 24 and 36 Months, as Assessed by the IRF
Time Frame
Randomization up to 24 months and up to 36 months
Title
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
Time Frame
Randomization up to 24 months and up to 36 months
Title
OS Rate at 24 and 36 Months
Description
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
Time Frame
Baseline to 24 and 36 months
Title
Time to Extrahepatic Spread (EHS) or Macrovascular Invasion
Description
Time to EHS or macrovascular invasion after randomization, defined as the time from randomization to the first appearance of EHS or macrovascular invasion, as determined by the investigator.
Time Frame
Baseline up to approximately 91 months
Title
RFS in Pd-L1-High Subgroup
Description
RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup.
Time Frame
Baseline up to approximately 91 months
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline up to approximately 91 months
Title
Serum Concentration of Atezolizumab
Time Frame
Prior to any drug administration on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16 (each cycle is 21 days)
Title
Number of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame
Prior to any drug administration on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16 (each cycle is 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only) within 4-12 weeks prior to randomization Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA only) Absence of major macrovascular invasion (except Vp1/Vp2) and extrahepatic spread Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following curative procedure Full recovery from surgical resection or ablation within 4 weeks prior to randomization High risk for HCC recurrence after resection or ablation For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization For patients with resected HCC, availability of a representative baseline tumor tissue sample ECOG Performance Status of 0 or 1 Child-Pugh Class A status Adequate hematologic and end-organ function For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC Evidence of residual, recurrent, or metastatic disease at randomization Clinically significant ascites History of hepatic encephalopathy Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization Have received more than 1 cycle of adjuvant TACE following surgical resection Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death Active tuberculosis Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to Day 1 of Cycle 1. Co-infection with HBV and HCV Co-infection with HBV and hepatitis D viral infection Clinical significant uncontrolled or symptomatic hypercalcemia Any treatment for HCC prior to resection or ablation, including systemic therapy and locoregional therapy such as TACE Treatment with systemic immunostimulatory or immunosuppressive agents Inadequately controlled arterial hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease Evidence of bleeding diathesis or significant coagulopathy Current or recent use of aspirin or full-dose oral or parenteral anticoagulants Core biopsy within 3 days of Day 1 of Cycle 1 History of GI fistula, GI perforation, or intra-abdominal abscess Serious non-healing or dehiscing wound Major surgical procedure within four weeks Chronic daily treatment with a non-steroidal anti-inflammatory drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Cancer Inst.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Riverina Cancer Care Centre
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Facility Name
Lkh-Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Imeldaziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Delta (Campus Rumbeke)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Sociedade beneficente de senhoras Hospital Sirio Libanes
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Hospital do Cancer UOPECCAN; Pesquisa Clínica
City
Cascavel
State/Province
PR
ZIP/Postal Code
85806-300
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz; Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
Gordon & Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
McGill University Health Centre - Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Peking Union Medical College Hospital
City
Beijing City
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Affiliated Hospital of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233004
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Daping Hospital of Third Military Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
ZIP/Postal Code
116027
Country
China
Facility Name
Mengchao Hepatobiliary Hospital Of Fujian Medical University
City
Fuzhou City
ZIP/Postal Code
350025
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Zhujiang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510280
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
City
Hangzhou City
ZIP/Postal Code
310022
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Anhui Province Cancer Hospital
City
Hefei City
ZIP/Postal Code
230031
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230601
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
The 81st Hospital of P.L.A.
City
Nanjing City
ZIP/Postal Code
210002
Country
China
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Facility Name
Zhongda Hospital Affiliated to Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Guangxi Cancer Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
The First Affiliate Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Zhongshan Hospital Fudan Unvierstiy
City
Shanghai City
ZIP/Postal Code
200032
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang City
ZIP/Postal Code
110001
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
ShenYang
ZIP/Postal Code
110004
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The Tumor Hospital of Xinjiang Medical University
City
Urumqi
ZIP/Postal Code
830000
Country
China
Facility Name
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430022
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430071
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Northern Jangsu People's Hospital
City
Yangzhou City
ZIP/Postal Code
225001
Country
China
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Hopital Jean Minoz; Oncologie
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis; Service d'Hépatologie
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Hôpital Albert Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Fondation Hopital Saint Joseph; Gastro-Enterologie
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
CHU Bordeaux - Hôpital Haut-Lévêque; Service d?Hépato-Gastroentérologie et d Oncologie digestive
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Robert Debre; Gastro Enterologie
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hopital de Pontchaillou; Service Hepato Gastro Enterologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Toulouse - Hôpital Rangueil
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Hopitaux de Brabois - Gastro-Entereologie
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.; Onkologische Gastroenterologie
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Queen Mary Hospital; Dept. Of Haematology & Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital; Department of Clinical Onocology
City
Shatin
Country
Hong Kong
Facility Name
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Asst Santi Paolo E Carlo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Ehime Prefectural Central Hospital
City
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Sapporo Kosei Genaral Hospital
City
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Hyogo Medical University Hospital
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Japanese Red Cross Society Himeji Hospital
City
Hyogo
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
Kanazawa University Hospital
City
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Osaka Red Cross Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Japanese Red Cross Musashino Hospital
City
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Borame Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Ulsan University Hosiptal
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Centro Medico Dalinde
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Filios Alta Medicina
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
City
Lima
ZIP/Postal Code
15088
Country
Peru
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Onkologii i Radioterapii,
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
First Moscow State Medical University n.a. I.M. Sechenov
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Group of companies "Medci"
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
City
Pesochny
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Tan Tock Seng Hospital; Oncology
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Infanta Cristina; Servicio de Oncologia
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Changhua Christian Hospital
City
Chang Hua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Gastroenterology Division
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital; Medical Oncology Unit
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chiang Rai Prachanukroh Hospital; Department Of Medicine
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Chulabhorn Hospital; Medical Oncology
City
Lak Si
ZIP/Postal Code
10210
Country
Thailand
Facility Name
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
Citations:
PubMed Identifier
32352320
Citation
Hack SP, Spahn J, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Yopp A, Chow P, Qin S. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncol. 2020 May;16(15):975-989. doi: 10.2217/fon-2020-0162. Epub 2020 Apr 30. Erratum In: Future Oncol. 2020 Oct;16(29):2371.
Results Reference
derived

Learn more about this trial

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

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