Actively Recruiting
TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma: Study on Efficacy and Immune Microenvironment
Led by Fudan University · Updated on 2025-08-17
50
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in Patients with Advanced Hepatocellular Carcinoma treated with TACE Combined with PD-1 Inhibitor.
CONDITIONS
Official Title
TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma: Study on Efficacy and Immune Microenvironment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- BCLC stage C or stage B hepatocellular carcinoma not suitable for curative or locoregional therapies
- Diagnosis of hepatocellular carcinoma
- At least one measurable tumor site by CT or MRI using modified RECIST criteria
- No prior anticancer therapy including TACE, HAIC, chemotherapy, targeted therapy, or immunotherapy
- Planned to receive TACE plus PD-1 inhibitor as first-line treatment
- ECOG performance status of 0 or 1
- Adequate organ function including ANC ≥1.5 × 10⁹/L, platelets ≥60 × 10⁹/L, hemoglobin ≥9 g/dL
- Total bilirubin ≤1.5 times upper limit of normal (ULN), AST/ALT ≤3 times ULN (≤5 times ULN if liver metastases)
- Creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL/min
- Willingness to provide archival or fresh tumor tissue and peripheral blood samples
- Signed informed consent
You will not qualify if you...
- Prior systemic therapy for hepatocellular carcinoma
- Active autoimmune disease requiring immunosuppression
- Active infection requiring intravenous antibiotics
- HIV positive or active hepatitis B or C infection with specified viral load thresholds
- Symptomatic central nervous system metastases
- Pregnancy or lactation
- Any condition that may affect compliance with the study or interpretation of data as judged by the investigator
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
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here