Actively Recruiting
A Prospective, Single-Center, Randomized, Double-Blind Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 for Advanced Hepatocellular Carcinoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-24
36
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early effectiveness of a combination treatment involving Transarterial Chemoembolization (TACE), sintilimab, bevacizumab, and ipilimumab N01 in adults with advanced hepatocellular carcinoma (HCC). The study aims to determine how safe and effective this combination is and to explore how different timing schedules of ipilimumab N01 affect outcomes. It also investigates biomarkers that might predict treatment responses. Participants are randomly assigned to one of three treatment groups: Group A receives TACE, sintilimab, bevacizumab, and a single dose of ipilimumab N01 three weeks after the first dose of sintilimab and bevacizumab; Group B receives TACE, sintilimab, bevacizumab, and a single dose of ipilimumab N01 concurrently with the first dose of sintilimab and bevacizumab; Group C receives TACE, sintilimab, and bevacizumab without ipilimumab N01. Treatments are given intravenously every three weeks, with TACE performed as part of the therapy. During the study, participants undergo regular clinic visits for safety checks and tumor imaging every six weeks initially, then every twelve weeks after 48 weeks. Biological samples such as blood and tumor biopsies are collected at baseline and during treatment for biomarker analysis. A safety follow-up occurs 30 days after the last dose, and survival follow-up contacts happen every 90 days to monitor survival status and subsequent treatments. The study continues until disease progression, intolerable side effects, or withdrawal.
CONDITIONS
Brief Title
A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Clinically confirmed unresectable or metastatic hepatocellular carcinoma
- Male or female aged 18 to 75 years
- ECOG Performance Status score of 0 or 1
- Expected survival time greater than 3 months
- Barcelona Clinic Liver Cancer Stage B or C for unresectable HCC
- Suitable for Transarterial Chemoembolization (TACE) treatment
- Child-Pugh score of 7 or less
- At least one measurable lesion according to RECIST 1.1 criteria
You will not qualify if you...
- HCC with fibrolamellar, sarcomatoid, or cholangiocarcinoma components
- History of liver transplantation or hepatic encephalopathy
- Diffuse liver cancer
- Unable to tolerate TACE or prior TACE treatment
- Prior treatment with TACE, TAE, or TARE
- Previous systemic anti-tumor therapy or radiotherapy for HCC
- Portal vein main trunk tumor thrombus without collateral circulation or involvement of major veins
- Symptomatic pleural effusion, ascites, or pericardial effusion needing drainage
- History of renal disease or nephrotic syndrome
- Recent variceal bleeding or high-risk portal hypertension
- Life-threatening bleeding within past 3 months
- Recent arterial or venous thromboembolic events
- Significant bleeding tendency or coagulopathy
- Long-term use of platelet function inhibitors
- Uncontrolled hypertension or serious heart conditions
- Recent major surgery or unhealed wounds
- History or presence of serious pulmonary diseases
- Active tuberculosis or recent anti-TB treatment
- Known HIV or syphilis infection
- Active or severe infection within 4 weeks prior to first dose
- Active autoimmune disease requiring systemic treatment within 2 years
- Recent use of immunosuppressive medications
- Recent live attenuated vaccine use
- Recent use of certain traditional Chinese medicines or immunomodulatory drugs
- Uncontrolled metabolic or systemic diseases
- Other malignancies within 5 years except certain skin cancers
- Previous immunotherapy treatments
- Allergy to study drugs or severe reactions to monoclonal antibodies
- Use of other investigational agents within 4 weeks
- Pregnant or breastfeeding women
- Any other condition increasing risk or affecting study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression, intolerable toxicity, or withdrawal from the study
Participants receive assigned combination therapy including TACE, sintilimab, bevacizumab, and optionally ipilimumab N01 according to group assignment. They undergo regular clinic visits for safety checkups, tumor imaging assessments, and response evaluations.
Clinic visits every 3 weeks initially, tumor imaging every 6 weeks initially, then every 12 weeks after 48 weeks
Duration - Up to 24 months after randomization
Participants have a safety follow-up visit about 30 days after the last study drug dose and subsequent survival follow-up contacts every 90 days to monitor survival status and any further treatments until death, withdrawal, or study closure.
1 safety follow-up visit and subsequent survival follow-up contacts every 90 days (may be via phone)
Trial Site Locations
Total: 1 location
1
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Z
Zhongquan Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here