RecruitingPhase 3NCT03949231

Infusion of PD1/PDL1/CTLA4 Inhibitors Via Hepatic Arterial for Immunotherapy of Hepatocellular Carcinoma

A Phase II/III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1/CTLA4 Inhibitor or Their Combinations Via Hepatic Arterial Infusion Versus Vein for Immunotherapy of Advanced Liver Cancer


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

200 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This trial was designed to investigate the survival outcomes, response rates, and safety of patients with Barcelona-Clinical Hepatocellular Carcinoma (BCLC)-C-stage liver cancer by hepatic artery versus vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether delivering immunotherapy drugs (checkpoint inhibitors like PD-1/PD-L1/CTLA-4 blockers) directly into the liver artery — rather than through a standard IV infusion — is more effective for treating hepatocellular carcinoma (the most common type of liver cancer). Direct delivery may increase the concentration of the drug at the tumor site. **You may be eligible if...** - You have a confirmed diagnosis of liver cancer (hepatocellular carcinoma) - You are between 18 and 80 years old with an estimated survival of more than 3 months - Your liver function is in acceptable range (Child-Pugh class A or B) - You are in reasonably good physical condition (ECOG score under 2) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have serious blood clotting problems that cannot be corrected - You have severe liver failure - You have active autoimmune disease - You are pregnant or breastfeeding - You have widespread cancer spread to many organs 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

DRUGPD1/PDL1 inhibitor

Infusion of PD1/PDL1 inhibitor through peripheral vein or hepatic artery.


Locations(1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, China

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NCT03949231


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