Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment

Recruiting now

Conditions studied: Advanced Hepatocellular Carcinoma (HCC)

In brief

To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.

Key facts

Study ID: NCT07147101
Run by: Fudan University
People needed: 150
Starts: 2025-09-01
Expected to finish: 2028-09-01
Last updated by the study team: 2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years at time of study entry.
Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies.
HCC conﬁrmed by radiology, histology or cytology.
No prior systemic therapy for HCC.
At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI.
Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
Adequate organ function:
ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL.
Total bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN (≤5 × ULN if liver metastases).
Creatinine ≤1.5 × ULN or CrCl ≥60 mL/min.
Willing to provide archival/fresh tumor tissue and peripheral blood samples.
Signed informed consent.

You may not qualify if…

Prior systemic therapy for HCC
Active autoimmune disease requiring immunosuppression.
Active infection requiring IV antibiotics.
HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).
Symptomatic CNS metastases.
Pregnancy/lactation.
Any condition compromising protocol compliance or data interpretation per investigator.

Where it is running

Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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