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

NCT07100405 | Recruiting

• 1 other identifier: TASK-01-RW
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  max 24 months

Secondary Outcomes (6)

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

  max 24 months

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

  max 24 months

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

  max 24 months

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

  max 24 months

• Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 42 months

Other Outcomes (1)

• Translational study

  max 42 months

Study Arms (1)

TACE+PD1 inhibitor

Drug: PD-1 inhibitor; Procedure: TACE

Interventions

PD-1 inhibitor DRUG

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+PD1 inhibitor

TACE PROCEDURE

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

TACE+PD1 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A baseline tumor biopsy and blood collection before initiation of treatment, followed by a second tumor biopsy with paired blood collection after the first response evaluation will be planned.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Peng Wang, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)