Actively Recruiting
A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics
Led by Fudan University · Updated on 2026-04-21
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced hepatocellular carcinoma (HCC) patients to evaluate how different first-line immunotherapy treatments affect the disease and the immune environment within tumors. This observational study compares combinations of immunotherapies, including anti-PD1 plus anti-VEGF, anti-PD1 plus tyrosine kinase inhibitors (TKI), and anti-PD1 plus anti-CTLA4 therapies. The goal is to understand treatment response rates and changes in immune cells in the blood and tumor tissue. The treatments being studied include three main groups: Sintilimab with a bevacizumab biosimilar given intravenously every three weeks, Camrelizumab with oral Rivoceranib daily plus intravenous Camrelizumab every two weeks, and a combination of Nivolumab and Ipilimumab administered intravenously on specific schedules. This non-interventional study observes patients receiving these treatments as part of their care without altering assigned therapies. Participants will be monitored for up to 42 months with evaluations including tumor scans to measure response, blood tests, and tissue samples to analyze immune profiles before and after treatment. Researchers will track objective response rates, disease control, duration and time to response, progression-free survival, overall survival, and any treatment-related side effects. The study aims to gather detailed information about how these immunotherapies work in advanced HCC and their effects on the immune system.
CONDITIONS
Brief Title
Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of study entry
- Barcelona Clinic Liver Cancer stage C, or stage B not suitable for curative or locoregional therapies
- Hepatocellular carcinoma confirmed by radiology, histology, or cytology
- No prior systemic therapy for hepatocellular carcinoma
- At least one measurable disease site by RECIST1.1 criteria using CT scan or MRI
- Child-Pugh score between 5 and 7, performance status of 0 to 2 on ECOG scale
- Adequate organ function including ANC 61.5 x 10^9/L, platelets 61100 x 10^9/L, hemoglobin 619 g/dL
- Total bilirubin 61.5 times upper limit of normal, AST/ALT 643 times upper limit (or 645 if liver metastases)
- Creatinine 61.5 times upper limit or creatinine clearance 6560 mL/min
- Willing to provide tumor tissue and blood samples
- Signed informed consent
You will not qualify if you...
- Prior systemic therapy for hepatocellular carcinoma
- Active autoimmune disease needing immunosuppression
- Active infection requiring intravenous antibiotics
- HIV-positive or active HBV/HCV infection with specified viral load thresholds
- Symptomatic central nervous system metastases
- Pregnancy or breastfeeding
- Any condition that may affect compliance or data interpretation as judged by the 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 - Up to 24 months
Participants receiving different first-line immunotherapy for advanced hepatocellular carcinoma are observed to evaluate treatment efficacy and immune microenvironment changes.
Regular visits aligned with treatment schedules for assessments
Duration - Up to 42 months
Participants are followed for overall survival and long-term safety outcomes after treatment.
Periodic follow-up visits
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
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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