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Recruiting NCT07100405

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

— Observational Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1 inhibitor, TACE.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Non-interventional Study of TACE Combined With PD-1 Inhibitor in Patients With Advanced Hepatocellular Carcinoma: Efficacy and Immune Microenvironment Dynamics

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
Secondary outcome measures (6)
  • Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 42 months]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: max 42 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07100405 · TASK-01-RW

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗