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

Fudan University50 enrolled

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. 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

PD-1 inhibitorDRUG

An approved agent (e.g., Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, etc.) will be selected based on clinical practice and administered at standard doses and schedules.

TACEPROCEDURE

TACE is performed by using embolic agent combined with Lipiodol-pirarubicin emulsion per Investigator decision

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

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.

Time frame: max 24 months

Secondary Outcomes

Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (S.D)

Time frame: max 24 months

Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment.

Time frame: max 24 months

Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed

Time frame: max 24 months

Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)

Time frame: max 24 months

Central Contacts

Peng Wang, MD

CONTACT

86-21-64041990 peng_wang@fudan.edu.cn

Data from ClinicalTrials.gov

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