RecruitingPhase 2NCT06828380

A Study Comparing Immunotherapy Alone Versus Immunotherapy Combined With Radiotherapy in Patients With Hepatocellular Carcinoma (HCC) With Vascular Invasion

A Phase II Study of Immunotherapy With or Without Particle Beam Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma Who Have Vascular Invasion: IOPT Study


Sponsor

National Cancer Center, Korea

Enrollment

128 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for liver cancer (hepatocellular carcinoma, or HCC) that has invaded blood vessels — a serious condition that makes surgery difficult. Patients will receive either immunotherapy alone or immunotherapy combined with radiation therapy, to see which approach works better. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with liver cancer (HCC) confirmed by imaging or biopsy - Your cancer is unresectable or has spread, and it has invaded major blood vessels (such as the portal vein or hepatic vein) - You have not previously received systemic (whole-body) treatment for liver cancer - Your liver function is within acceptable limits **You may NOT be eligible if...** - You have previously received systemic therapy for HCC - You have other active cancers - You have severe liver dysfunction or uncontrolled liver disease - You have autoimmune conditions that would make immunotherapy unsafe - You are unable to provide informed consent 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

RADIATIONParticle beam radiation therapy

The prescribed dose and fractionation for proton therapy to the PTV will be determined by the physician, taking into account the dose-volume constraints of normal tissues such as the liver and bowel.


Locations(2)

National Cancer Center

Goyang, South Korea

Samsung Medical Center, Seoul

Seoul, South Korea

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NCT06828380


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