Actively Recruiting
A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma
Led by Fudan University · Updated on 2026-04-21
350
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, multi-arm, Bayesian adaptive platform trial designed to efficiently evaluate novel therapies for advanced hepatocellular carcinoma (HCC) after first-line treatment failure. The study aims to rapidly identify the most effective investigational regimens and discover predictive biomarker signatures (from tumor tissue, blood, and imaging) to guide personalized second-line therapy.
CONDITIONS
Official Title
A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained.
- Age 18 years or older at time of study entry.
- Locally advanced or metastatic and/or unresectable hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria.
- Prior first-line therapy with anti-PD-1/PD-L1 combined with anti-VEGF antibodies, TKI, or anti-CTLA-4 antibodies with disease progression or recurrence within 6 months after neoadjuvant/adjuvant immunotherapy.
- At least one measurable target lesion not previously treated or progressed after local therapy.
- Child-Pugh score between 5 and 7, with performance status 0 to 2 on ECOG scale.
- For chronic HBV infection, HBV DNA viral load less than 100 IU/mL and receiving antiviral therapy.
- Life expectancy of at least 12 weeks.
- Adequate blood counts, liver enzymes, renal function, and coagulation parameters within specified limits.
- Negative pregnancy test within 7 days prior to trial start for females of reproductive potential.
- Willingness and ability to comply with study protocol, treatments, contraceptive measures, and scheduled visits.
You will not qualify if you...
- Known fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and hepatocellular carcinoma.
- Listed for liver transplantation or with advanced liver disease.
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before treatment.
- Thrombotic or embolic events within 6 months prior to study drug except segmental portal vein thrombosis.
- Presence of second primary cancer except treated basal skin cancer or carcinoma in situ of cervix.
- Immunocompromised status including HIV positive.
- Participation in another investigational trial within 30 days or 7 half-lives of previous medication.
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, HBV/HCV coinfection, pancreatitis, active infections, organ transplant, immunodeficiency, recent systemic steroids or immunosuppressive therapy, active autoimmune disease requiring treatment, recent live vaccine, or CNS metastases unless meeting specific criteria.
- Use of medications interfering with trial agents.
- Receipt of other cancer treatments except protocol-specified at study start.
- Receipt of investigational product within 28 days before study entry.
- Pregnant or breastfeeding females or patients not using effective birth control.
- History of non-compliance or inability to provide reliable 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
9
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