RecruitingPhase 2NCT07246668

A Phase II Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Carbon Ion Radiotherapy With Atezolizumab and Bevacizumab Combination Therapy in Patients With Advanced Hepatocellular Carcinoma


Sponsor

Yonsei University

Enrollment

52 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This single-center, prospective phase II clinical trial evaluates the safety and therapeutic efficacy of combining carbon ion radiotherapy with the standard first-line regimen of atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma. The study aims to determine whether the addition of carbon ion radiotherapy enhances tumor control and improves clinical outcomes beyond those achieved with systemic therapy alone. Key endpoints include overall survival, progression-free survival, objective response rate, and treatment-related adverse events.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining carbon ion radiotherapy (a highly precise form of radiation that targets tumors with minimal damage to surrounding tissue) with two immunotherapy/targeted drugs — atezolizumab and bevacizumab — for patients with advanced liver cancer (hepatocellular carcinoma) who are not candidates for surgery or transplant. **You may be eligible if...** - You are 18 or older with confirmed liver cancer - Your cancer is BCLC stage B or C (intermediate or advanced) - You are not eligible for surgery or liver transplant - You are a suitable candidate for atezolizumab plus bevacizumab treatment - You have at least one measurable tumor **You may NOT be eligible if...** - Your liver function is too poor (e.g., Child-Pugh class C) - You have active autoimmune disease or are on immune-suppressing drugs - You have uncontrolled bleeding or severe blood vessel abnormalities - You have active brain metastases 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

RADIATIONCarbon Ion Radiotherapy Atezolizumab Bevacizumab

Participants will initiate systemic therapy with atezolizumab (1200 mg IV every 3 weeks) and bevacizumab (15 mg/kg IV every 3 weeks). Carbon ion radiotherapy will subsequently be administered to the primary hepatic lesion during the early phase of systemic therapy. Carbon ion radiotherapy will be delivered using a hypofractionated schedule (approximately 4-12 fractions), with dose and fractionation individualized based on tumor size, anatomical location, and organ-at-risk considerations. After completion of carbon ion radiotherapy, participants will continue maintenance treatment with atezolizumab and bevacizumab until disease progression or unacceptable toxicity.


Locations(1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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NCT07246668


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