Actively Recruiting
The HCC-SIGHT: A Therapy Platform Trial for Hepatocellular Carcinoma Guided by Stratification Imaging and Genetic Horizon Testing
Led by Fudan University · Updated on 2026-04-21
350
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for advanced hepatocellular carcinoma (HCC) in patients whose first-line therapies have not been successful. This phase II adaptive platform trial aims to quickly identify the most effective second-line treatment options and discover biomarkers from tumor tissue, blood, and imaging that can help personalize therapy. The study uses a Bayesian design to adjust treatments based on ongoing results, optimizing therapy choices for participants with advanced liver cancer. Participants will be randomly assigned to one of several treatment groups. These include drugs such as Lenvatinib or Regorafenib alone, combinations of Tislelizumab with tyrosine kinase inhibitors (TKIs), hepatic arterial infusion chemotherapy (HAIC) with or without additional immunotherapy agents like Tislelizumab, QL1706, or Camrelizumab, and chemotherapy regimens combined with these drugs. Treatments involve oral medications and intravenous infusions given in cycles, with some repeated every 3 weeks for up to 4 cycles. The study allows dropping less effective treatments and adding new ones as the trial progresses. During the study, participants will undergo tumor assessments using imaging and biomarker tests from tissue and blood samples to monitor response. Researchers will evaluate outcomes such as objective response rate, disease control, duration and time to response, progression-free survival, overall survival, and treatment-related side effects. The trial includes regular visits and assessments for up to 42 months, with ongoing safety monitoring and data collection to better understand which therapies work best for different patient groups.
CONDITIONS
Brief 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 study entry.
- Locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria.
- Prior first-line therapy with specific immunotherapy combinations and disease progression or recurrence within 6 months after neoadjuvant/adjuvant immunotherapy.
- At least one measurable target lesion by RECIST v1.1 not previously treated or showing progression.
- Child-Pugh score between 5 and 7 and ECOG performance status 0 to 2.
- Chronic hepatitis B patients must have low viral load and be on antiviral therapy per guidelines.
- Life expectancy of at least 12 weeks.
- Adequate blood counts, liver enzymes, and kidney function within specified limits.
- Negative pregnancy test for women with reproductive potential within 7 days before trial start.
- Willingness and ability to comply with study protocols including treatment, contraception, visits, and follow-up.
You will not qualify if you...
- Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma-hepatocellular carcinoma.
- Listed for liver transplant or with advanced liver disease.
- Recent significant cardiac disease or gastrointestinal bleeding.
- Recent thrombotic or embolic events within 6 months except certain portal vein thrombosis.
- Second primary cancer except treated basal skin cancer or cervical carcinoma in-situ.
- Immunocompromised status including HIV positive.
- Participation in another investigational study within 30 days or 7 half-lives of prior drugs.
- Conditions interfering with treatment evaluation or safety, including interstitial lung disease, coinfections, pancreatitis, active infections, organ transplants, immunodeficiency, immunosuppressive therapy, active autoimmune disease requiring systemic treatment except specified exceptions.
- Live vaccines within 30 days before or during treatment.
- CNS metastases unless treated and stable without steroids.
- Medications interfering with study drugs.
- Use of other cancer treatments at study start except protocol treatments.
- Pregnancy, breastfeeding, or inadequate contraception.
- History of non-compliance or inability to provide reliable consent.
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 - Up to 24 months
Participants are randomly assigned to receive one of several drug regimens including oral tyrosine kinase inhibitors, immunotherapy, hepatic arterial infusion chemotherapy, or combinations thereof as second-line treatment for advanced hepatocellular carcinoma.
Repeated visits every 3 to 4 weeks corresponding with treatment cycles
Duration - Up to 18 months following treatment completion
Participants are monitored for long-term outcomes including survival, disease progression, and treatment-related adverse events after completing treatment.
Periodic visits for assessments up to 42 months total from enrollment
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
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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