Actively Recruiting
HAIC Combined With Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)
Led by Fudan University · Updated on 2026-04-21
164
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.
CONDITIONS
Official Title
HAIC Combined With Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent is provided.
- Age 18 years or older at study entry.
- Barcelona Clinic Liver Cancer stage C, or stage B not suitable for curative or local therapies.
- Diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology.
- No previous systemic treatment for hepatocellular carcinoma.
- At least one measurable tumor site per RECIST 1.1 criteria using CT or MRI.
- Child-Pugh score between 5 and 7, and ECOG performance status of 0 to 2.
- For patients with chronic hepatitis B virus infection, HBV DNA viral load below 100 IU/mL and on antiviral treatment as per regional guidelines before study therapy.
- Life expectancy of at least 12 weeks.
- Adequate blood counts, liver enzymes, and kidney function within specified limits.
- Female participants with reproductive potential must have a negative pregnancy test within 7 days before starting the study.
- Willingness and ability to follow the study protocol, including treatment, contraception, visits, and exams.
You will not qualify if you...
- Patients listed for liver transplantation or with advanced liver disease.
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before study start.
- Thrombotic or embolic events (like stroke, deep vein thrombosis, pulmonary embolism) within 6 months before first dose, except segmental portal vein thrombosis.
- Previous systemic anticancer, endocrine, or immunotherapy.
- Prior treatment with hepatic arterial infusion chemotherapy.
- Radiotherapy within 4 weeks before study treatment.
- Major surgery within 4 weeks before study or incomplete recovery from surgery.
- Presence of a second primary cancer, except treated basal skin cancer or cervical carcinoma in situ.
- Immunocompromised conditions, including HIV infection.
- Participation in another clinical trial with investigational products within 30 days or 7 half-lives of prior medication.
- Previous participation in this study (excluding screening failures).
- Conditions interfering with study treatment evaluation or safety, such as interstitial lung disease, HBV and HCV coinfection, pancreatitis, active tuberculosis or infections, organ transplant, immunodeficiency, recent systemic steroid or immunosuppressive therapy, active autoimmune diseases requiring systemic treatment (with some exceptions).
- Live vaccine within 30 days before or during study treatment.
- Central nervous system metastases unless treated, asymptomatic, and steroid-free for 6 weeks prior to treatment.
- Medications interfering with study drugs.
- Any other cancer treatment besides the study protocol at start.
- Use of other investigational products within 28 days before study.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies.
- Pregnant or breastfeeding women, or patients of reproductive potential not using effective contraception.
- History of significant non-compliance or inability to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
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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