Overview
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.
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.
Eligibility
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.