Actively Recruiting
Hepatic Arterial Infusion or Intravenous Infusion of Adebrelimab Combined With Bevacizumab and Hepatic Arterial Infusion of FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2026-03-30
76
Participants Needed
1
Research Sites
26 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
Researchers are evaluating the safety and effectiveness of Adabrelimab combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as a first treatment for advanced stage hepatocellular carcinoma (HCC). The study compares two methods of delivering Adabrelimab: directly into the hepatic artery or intravenously. This phase II trial aims to improve response rates and outcomes beyond current treatments for advanced liver cancer. Participants will be randomly assigned to one of two groups. One group receives hepatic arterial infusion of Adabrelimab along with intravenous Bevacizumab and hepatic artery infusion chemotherapy using the FOLFOX regimen. The other group receives intravenous Adabrelimab combined with intravenous Bevacizumab plus the same hepatic artery FOLFOX chemotherapy. Both groups continue the triple combination for up to six cycles, then receive maintenance treatment with intravenous Adabrelimab and Bevacizumab until disease progression or unacceptable side effects occur. During the study, participants will undergo regular assessments including imaging to measure tumor response at six weeks and follow-up for progression-free survival, overall survival, and other outcomes up to 36 months. Safety will be monitored from consent through 30 days after the last treatment dose. The trial involves detailed lab tests, clinical evaluations, and scans to track treatment effects and side effects over time, with total participation lasting several years.
CONDITIONS
Brief 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
- Aged 18 years or older
- Diagnosed with hepatocellular carcinoma by clinical or pathological methods
- Barcelona Clinic Liver Cancer stage C with vascular or bile duct invasion or distant metastasis (excluding Vp4-type tumor thrombus)
- No prior systemic therapy for HCC or progression after prior local therapy with at least one month since last treatment
- ECOG Performance Status score of 0-1 and Child-Pugh grade A or B (score 7)
- No history of autoimmune disease
- Expected survival time of at least 3 months
- At least one measurable lesion per RECIST v1.1 criteria
- Adequate blood, liver, and kidney function within one week prior to enrollment
- Women of childbearing potential must have negative pregnancy test and agree to contraception during and 6 months after study; men must agree to contraception during and 6 months after study
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 one month prior to randomization
- Active infections that cannot be controlled
- Severe or untreated gastroesophageal varices with bleeding risk
- Brain or bone metastases requiring urgent surgery or radiotherapy
- Pregnant, suspected pregnant, or breastfeeding
- Recent use of certain antiplatelet drugs within 10 days before study treatment
- Recent thrombotic or embolic events within 6 months prior to treatment
- Congenital or acquired immunodeficiency
- History of other malignant tumors
- Recent serious heart conditions within 12 months prior to treatment
- Renal failure requiring dialysis
- History of organ transplantation
- Severe physical or mental illness or lab abnormalities increasing study risk or interfering with results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of approximately 3 weeks each)
Participants receive either hepatic arterial infusion of Adebrelimab combined with intravenous Bevacizumab and hepatic artery infusion chemotherapy with FOLFOX, or intravenous Adebrelimab combined with intravenous Bevacizumab and hepatic artery infusion chemotherapy with FOLFOX. This triple combination treatment is given up to 6 cycles.
Visits every 3 to 4 weeks for infusions and chemotherapy administration
Duration - Until disease progression or intolerable toxicity
After completing up to 6 cycles of the triple combination, participants continue with intravenous maintenance therapy of Adebrelimab and Bevacizumab until disease progression or intolerable toxicity.
Regular intravenous infusion visits every 3 weeks
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.
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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