TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma: Study on Efficacy and Immune Microenvironment

Recruiting now

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT07100405

Run by

Fudan University

People needed

50

Starts

2025-08-15

Expected to finish

2028-08-01

Last updated by the study team

2025-08-17

Who can join

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

You may qualify if…

• Age ≥18 years.
• BCLC stage C, and stage B who are not amenable to curative or locoregional therapies.
• Diagnosis of hepatocellular carcinoma.
• At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI.
• No prior anticancer therapy, including TACE/HAIC, chemotherapy, targeted therapy, or immunotherapy).
• Planned to receive TACE plus anti-PD1 inhibitor as first-line treatment.
• ECOG performance status 0-1.
• Adequate organ function:
• ANC ≥1.5 × 10⁹/L, platelets ≥60 × 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.
• 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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