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Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion

Primary Purpose

Hepatocellular Carcinoma, Portal Vein Thrombosis

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PBT and atezolizumab/bevacizumab
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

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

Inclusion Criteria: Patients with HCC meeting all of following criteria; Histologically or radiologically confirmed hepatocellular carcinoma based on the guidelines of the Korean Liver Cancer Association-National Cancer Center 2022 Age >= 20 Vp2-4 portal vein tumor thrombosis diagnosed by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI) with below finding 1) an intraluminal filling defect adjacent to the primary tumor in Vp2-4 portal vein 2) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases. Signed written informed consent at least one or more measurable intrahepatic viable HCC lesions Child-Pugh class A within 2 weeks from screening for study registration Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 2 weeks from screening for study registration Life expectancy of at least 16 weeks adequate bone marrow and liver function within 2 weeks from screening for study registration Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count (ANC) ≥ 1,000/mm3 Platelet count ≥ 50,000/μL Total bilirubin < 2.5 mg/dL Serum albumin >2.8 g/dL Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN) Prothrombin time in INR ≤ 1.8 × ULN Serum creatinine ≤ 1.5 mg/dL Women of childbearing potential and men must agree to use highly efficient contraception since signing of the informed consent form until at least 6 months (women) and 7 months (men) after the last study drug administration If other selection conditions are satisfied and the exclusion criteria are not met, registration is possible even in case of N1 or M1. Registration is possible even in the case of hepatic vein tumor infiltration if other selection conditions are satisfied and the exclusion criteria are not met no limitation according to the size and number of tumors in the liver. Exclusion Criteria: Patients with HCC meeting all of following criteria; previous history of systemic treatment for HCC (If systemic treatment for HCC has been performed at least once, it will not be enrolled in this study.) However, registration is permitted if the previous systemic treatment is for adjuvant purposes or treatment for other cancers. Also allowed if previous HCC treatment is local treatment. However, cases with a history of previous upper abdominal radiotherapy (including proton therapy and heavy particle therapy) are excluded. any type of anticancer agent (including investigational) within 2 weeks before enrollment Having active brain metastasis or leptomeningeal metastasis need surgery or steroid therapy Moderate to severe or intractable ascites A history or presence of hepatic encephalopathy Presence of active bacterial infection Untreated active chronic hepatitis B or active hepatitis C History of portal hypertension with bleeding within the past 6 months Prior liver transplant Uncontrolled severe medical comorbidity unhealed wound uncontrolled electrolyte imbalance Non-interruptible therapeutic use of anticoagulants or thrombolytics History of uncontrolled or autoimmune disease, or immunocompromised interstitial lung disease Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years) Mentally retarded/medically incapable of consent

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PBT arm

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival rate
Incidence of adverse event assessed according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

Secondary Outcome Measures

Overall survival rate
Time-to-progression
Objective response rate
Disease Control rate
Local tumor progression rate

Full Information

First Posted
September 20, 2022
Last Updated
November 15, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05625893
Brief Title
Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion
Official Title
Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion: PORTAL Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

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

5. Study Description

Brief Summary
This study is investigator initiated, single-institution, prospective, phase 2 open-label study to determine the efficacy and safety of combination therapy of atezolizumab/bevacizumab and proton beam therapy to portal vein tumor thrombosis with or without main primary tumor in patients with stage 3 or higher hepatocellular carcinoma (HCC) with Vp2-4 portal vein invasion who had not undergone systemic therapy for HCC. The primary endpoint of this study is progression-free survival and secondary endpoints are overall survival (OS), time to progression (TTP), objective response rate, disease control rate (DCR), and time to local disease progression (LTP).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PBT arm
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
PBT and atezolizumab/bevacizumab
Intervention Description
Atezolizumab 1200 mg and bevacizumab 15 mg/Kg is administered IV infusion every 3 weeks. Proton beam therapy 30 - 50 Gy/5 fractions to portal vein tumor thrombosis with or without main primary tumor after 1 week (+/- 7 days) of 2nd cycle of atezolizumab and bevacizumab The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies.
Primary Outcome Measure Information:
Title
Progression-free survival rate
Time Frame
At 9 month
Title
Incidence of adverse event assessed according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Time Frame
From date of atezolizumab and bevacizumab initiatton until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Secondary Outcome Measure Information:
Title
Overall survival rate
Time Frame
At 12 month
Title
Time-to-progression
Time Frame
At 9 months
Title
Objective response rate
Time Frame
At 3 month
Title
Disease Control rate
Time Frame
At 3 month
Title
Local tumor progression rate
Time Frame
At 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with HCC meeting all of following criteria; Histologically or radiologically confirmed hepatocellular carcinoma based on the guidelines of the Korean Liver Cancer Association-National Cancer Center 2022 Age >= 20 Vp2-4 portal vein tumor thrombosis diagnosed by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI) with below finding 1) an intraluminal filling defect adjacent to the primary tumor in Vp2-4 portal vein 2) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases. Signed written informed consent at least one or more measurable intrahepatic viable HCC lesions Child-Pugh class A within 2 weeks from screening for study registration Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 2 weeks from screening for study registration Life expectancy of at least 16 weeks adequate bone marrow and liver function within 2 weeks from screening for study registration Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count (ANC) ≥ 1,000/mm3 Platelet count ≥ 50,000/μL Total bilirubin < 2.5 mg/dL Serum albumin >2.8 g/dL Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN) Prothrombin time in INR ≤ 1.8 × ULN Serum creatinine ≤ 1.5 mg/dL Women of childbearing potential and men must agree to use highly efficient contraception since signing of the informed consent form until at least 6 months (women) and 7 months (men) after the last study drug administration If other selection conditions are satisfied and the exclusion criteria are not met, registration is possible even in case of N1 or M1. Registration is possible even in the case of hepatic vein tumor infiltration if other selection conditions are satisfied and the exclusion criteria are not met no limitation according to the size and number of tumors in the liver. Exclusion Criteria: Patients with HCC meeting all of following criteria; previous history of systemic treatment for HCC (If systemic treatment for HCC has been performed at least once, it will not be enrolled in this study.) However, registration is permitted if the previous systemic treatment is for adjuvant purposes or treatment for other cancers. Also allowed if previous HCC treatment is local treatment. However, cases with a history of previous upper abdominal radiotherapy (including proton therapy and heavy particle therapy) are excluded. any type of anticancer agent (including investigational) within 2 weeks before enrollment Having active brain metastasis or leptomeningeal metastasis need surgery or steroid therapy Moderate to severe or intractable ascites A history or presence of hepatic encephalopathy Presence of active bacterial infection Untreated active chronic hepatitis B or active hepatitis C History of portal hypertension with bleeding within the past 6 months Prior liver transplant Uncontrolled severe medical comorbidity unhealed wound uncontrolled electrolyte imbalance Non-interruptible therapeutic use of anticoagulants or thrombolytics History of uncontrolled or autoimmune disease, or immunocompromised interstitial lung disease Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years) Mentally retarded/medically incapable of consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Il Yu, MD, PhD
Phone
82-2-3410-9598
Email
ro.yuji651@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Il Yu, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Il Yu, MD, PhD
Phone
82-2-3410-9598
Email
ro.yuji651@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion

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