TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma: Study on Efficacy and Immune Microenvironment (TASK-01-RW)

Fudan University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE; Drug: PD-1 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT07100405

TASK-01-RW

Details and patient eligibility

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.

Full description

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. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

TACE+PD1 inhibitor

Treatment:

Procedure: TACE

Drug: PD-1 inhibitor