PD-1 inhibitor: An approved agent (e.g., Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, etc.) will be selected based on clinical practice and administered at standard doses and schedules.
TACE: TACE is performed by using embolic agent combined with Lipiodol-pirarubicin emulsion per Investigator decision
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 — max 24 months ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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