Actively Recruiting
HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2026-03-30
76
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
H
Henan Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Patients will be randomized 1:1 etither to receive hepatic arterial infusion(HAI) Adabrelimab group or IV Adabrelimab group, and both groups will receive HAI FOLFOX chemotherapy and IV Bevacizumab.
CONDITIONS
Official Title
HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older at consent
- Diagnosed with hepatocellular carcinoma by clinical or pathological methods
- Barcelona Clinic Liver Cancer (BCLC) stage C with vascular or bile duct invasion or distant metastasis (excluding Vp4-type tumor thrombus)
- No prior systemic therapy for HCC or progression/residual disease after local therapies with at least one month since last treatment
- ECOG Performance Status 0-1 and Child-Pugh grade A or B (score 7)
- No history of autoimmune disease
- Expected survival time of 3 months or more
- At least one measurable lesion meeting RECIST v1.1 size criteria
- Adequate blood, liver, and kidney function based on specified lab values within one week before enrollment
- Women of childbearing potential must have negative pregnancy test within 7 days before enrollment, not breastfeeding, and agree to contraception during study and 6 months after; men must agree to contraception during study and 6 months after
You will not qualify if you...
- Severe allergy to iodine contrast agents preventing hepatic arterial infusion chemotherapy
- Use of immunosuppressants or systemic corticosteroids for immunosuppression within 1 month before randomization
- Active infections not effectively controlled
- Severe or untreated gastroesophageal varices with bleeding or high bleeding risk
- Brain or bone metastases needing urgent surgery or radiotherapy
- Pregnant, suspected pregnancy, or breastfeeding
- Use of aspirin (>325 mg/day), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 10 days before treatment start
- Thrombotic or embolic events within 6 months prior to treatment start
- Congenital or acquired immunodeficiency
- History of other cancers
- Myocardial infarction, severe unstable angina, or congestive heart failure within 12 months before treatment
- Renal failure requiring dialysis
- History of organ transplantation
- Severe acute or chronic illnesses or lab abnormalities that increase risk or interfere with study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
L
Lujun Shen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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