RecruitingNCT07100405

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


Sponsor

Fudan University

Enrollment

50 participants

Start Date

Aug 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is combining TACE (a procedure that delivers chemotherapy directly into liver tumors via a blood vessel) with an anti-PD-1 immunotherapy drug for people with advanced liver cancer (hepatocellular carcinoma) who have not yet received treatment. Researchers also want to study how the treatment changes the immune environment inside the tumor. **You may be eligible if...** - You are 18 or older - You have confirmed hepatocellular carcinoma at an advanced stage (or intermediate stage not suitable for curative treatment) - You have not received any prior cancer treatment (no chemotherapy, targeted therapy, immunotherapy, or TACE) - You have at least one measurable tumor - Your general health is good (ECOG 0–1) - Your liver, kidney, and blood counts are adequate **You may NOT be eligible if...** - You have received any prior systemic cancer treatment - You have an active autoimmune disease - You have an active infection requiring IV antibiotics - You are HIV-positive, or have active hepatitis B (with very high viral load) or hepatitis C - Your cancer has spread to the brain - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-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.

PROCEDURETACE

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


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07100405


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