NCT07100405

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-08-03
• Last updated: 2025-08-17

Locations

1 site across 1 country: China