Actively Recruiting
A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-24
36
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). It also aims to explore the potential synergistic mechanisms of this combination. The main questions it aims to answer are: Is the combination of TACE, sintilimab, bevacizumab, and ipilimumab N01 effective and safe for patients with advanced HCC? How do different sequencing schedules of ipilimumab N01 compare in terms of safety and efficacy? What potential biomarkers can predict treatment response? Researchers will compare three different treatment groups: Group A: Receives TACE and a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab. Group B: Receives TACE and a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab. Group C: Receives TACE, sintilimab and bevacizumab (without ipilimumab N01). Participants will: Be screened for eligibility and be randomly assigned to one of the three treatment groups. Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments, and response evaluation using RECIST v1.1 and RECICL criteria. Provide biological samples for exploratory biomarker analysis, including: Peripheral blood at baseline and before each treatment cycle (every 3 weeks). Tumor biopsy specimens at baseline and 6 weeks after the first treatment. Surgical specimens if the patient undergoes conversion surgery. Participate in follow-up visits: A safety follow-up visit 30 days after the last study drug dose or before starting new anti-cancer therapy. Subsequent survival follow-up contacts every 90 days to collect information on survival status and any subsequent anti-cancer treatments.
CONDITIONS
Official 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 written informed consent before any trial procedures
- Clinically confirmed unresectable or metastatic hepatocellular carcinoma (HCC)
- Male or female aged 18 to 75 years
- ECOG Performance Status of 0 or 1
- Expected survival time longer than 3 months
- Barcelona Clinic Liver Cancer (BCLC) 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 per RECIST 1.1 criteria
You will not qualify if you...
- HCC with fibrolamellar, sarcomatoid, or cholangiocarcinoma components
- History of liver transplant or hepatic encephalopathy
- Diffuse liver cancer
- Unable to tolerate TACE or prior TACE treatment
- Previous treatment with TACE, TAE, TARE, systemic anti-tumor therapy, or radiotherapy for HCC
- Major tumor thrombus in portal vein or inferior vena cava
- Symptomatic pleural effusion, ascites, or pericardial effusion needing drainage
- History of kidney disease or nephrotic syndrome
- Recent or severe esophageal/gastric variceal bleeding or high bleeding risk
- Life-threatening bleeding in past 3 months
- Recent serious arterial or venous thromboembolic events
- Significant bleeding disorders or on thrombolytic therapy
- Long-term use of platelet function inhibitors or uncontrolled hypertension
- Symptomatic heart failure or serious heart rhythm issues
- Recent major surgery or unhealed wounds
- History of severe lung diseases or impaired lung function
- Active tuberculosis or recent anti-TB treatment
- Known HIV or syphilis infection
- Active or poorly controlled severe infection within 4 weeks
- Active autoimmune disease needing systemic treatment within 2 years
- Recent use of immunosuppressive drugs (except certain corticosteroids)
- Recent live vaccine use
- Recent use of anti-tumor traditional Chinese medicine or immunomodulators
- Uncontrolled metabolic or systemic diseases
- Other malignancies within 5 years except certain skin cancers
- Prior immunotherapy with PD-1, PD-L1, CTLA-4 antibodies
- Known allergy to study drugs or severe hypersensitivity to monoclonal antibodies
- Use of other investigational drugs within 4 weeks
- Pregnant or breastfeeding females
- Any other condition increasing risk or interfering with study participation or results
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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