Back to resultsHAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HAIC of FOLFOX
H101
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Hepatic artery infusion chemotherapy, Oxaliplatin, 5-fluorouracil and leucovorin, Recombinant Human Type-5 Adenovirus
Eligibility Criteria
Inclusion Criteria:
- The diagnosis of HCC
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- With no previous treatment
- Single lesion with tumor size larger 7cm or multiple lesions
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- BCLC A-B stage
- The following laboratory parameters:
Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion Criteria:
- Patients complicated by history of heart disease, history of gastrointestinal bleeding within 1 month, severe infection (> grade 2 National Cancer Institute [NCI] -common Terminology Criteria for Adverse Events [CTCAE] version 4.0) or other serious associated diseases will not be able to tolerate treatment
- With other malignant tumors
- Known or suspected allergy to the investigational agents or any agent given in association with this trial
- History of organ allograft
- Pregnant or lactating woman
- patients with poor compliance
Sites / Locations
- Cancer Center Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HAIC plus H101
HAIC
Arm Description
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery
Outcomes
Primary Outcome Measures
Overall survival (OS)
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Secondary Outcome Measures
Progression free survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Number of adverse events
Postoperative adverse events were graded based on CTCAE v4.03
Conversion rate to resection
Patients receive subsequent resection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03780049
Brief Title
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B
Official Title
Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
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
Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Hepatic artery infusion chemotherapy, Oxaliplatin, 5-fluorouracil and leucovorin, Recombinant Human Type-5 Adenovirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HAIC plus H101
Arm Type
Experimental
Arm Description
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
Arm Title
HAIC
Arm Type
Active Comparator
Arm Description
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery
Intervention Type
Procedure
Intervention Name(s)
HAIC of FOLFOX
Other Intervention Name(s)
Hepatic artery infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
Intervention Description
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Intervention Type
Drug
Intervention Name(s)
H101
Other Intervention Name(s)
Recombinant Human Type-5 Adenovirus
Intervention Description
Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
normal saline
Intervention Description
Patients receive normal saline 10ml in each session of HAIC
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Time Frame
24 months
Title
Number of adverse events
Description
Postoperative adverse events were graded based on CTCAE v4.03
Time Frame
30 days
Title
Conversion rate to resection
Description
Patients receive subsequent resection.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis of HCC
Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
With no previous treatment
Single lesion with tumor size larger 7cm or multiple lesions
No Cirrhosis or cirrhotic status of Child-Pugh class A only
Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
BCLC A-B stage
The following laboratory parameters:
Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion Criteria:
Patients complicated by history of heart disease, history of gastrointestinal bleeding within 1 month, severe infection (> grade 2 National Cancer Institute [NCI] -common Terminology Criteria for Adverse Events [CTCAE] version 4.0) or other serious associated diseases will not be able to tolerate treatment
With other malignant tumors
Known or suspected allergy to the investigational agents or any agent given in association with this trial
History of organ allograft
Pregnant or lactating woman
patients with poor compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Shi, MD
Phone
+862087343938
Email
shiming@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Phone
8620-87343115
Email
shiming@mail.sysu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B
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