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

Launched by FUDAN UNIVERSITY · Jul 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with advanced liver cancer (hepatocellular carcinoma). It looks at how well a combination of two therapies works: TACE, a procedure that blocks blood flow to the tumor, and a type of medicine called an anti-PD-1 antibody, which helps the immune system fight cancer. The study also aims to understand how this treatment affects the immune environment around the tumor.

People who might be eligible for this trial are adults diagnosed with advanced liver cancer who have not yet received any cancer treatment. They need to have measurable tumors and be in good enough health to receive treatment. Participants will receive the combined TACE and anti-PD-1 therapy as their first treatment. The study will observe how their cancer responds and will collect blood and tumor samples to learn more about the immune system’s role. Importantly, this trial is not yet recruiting participants, but it is designed for adults of all genders who meet the health requirements and agree to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.