RecruitingNot ApplicableNCT07252323

A Single-arm Phase II Clinical Study Investigating the Safety and Efficacy of Carbon Ion Radiotherapy in Patients With Hepatocellular Carcinoma Previously Treated With Transarterial Radioembolization (TARE)


Sponsor

Yonsei University

Enrollment

48 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm Phase II study designed to evaluate the safety and efficacy of carbon ion radiotherapy in patients with hepatocellular carcinoma (HCC) who demonstrate residual or recurrent disease after prior transarterial radioembolization (TARE). Carbon ion radiotherapy delivers highly conformal, high-linear energy transfer radiation, enabling dose escalation to hepatic tumors while minimizing exposure to surrounding normal tissues. Eligible patients will receive carbon ion radiotherapy to target lesions, and clinical outcomes including objective response rate, progression-free survival, overall survival, and treatment-related toxicity will be systematically assessed. The study aims to determine whether carbon ion radiotherapy can provide effective local tumor control and acceptable safety in this population, thereby establishing evidence to guide its therapeutic role following TARE.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This phase II study tests whether carbon ion radiotherapy (a very precise type of radiation therapy) can safely and effectively treat liver cancer (hepatocellular carcinoma) in patients who still have tumor remaining in the liver after a prior treatment called TARE (a type of internal radiation delivered via a catheter into the liver's blood supply). **You may be eligible if...** - You are 19 or older - You have hepatocellular carcinoma confirmed by imaging or biopsy - You have a residual or recurring tumor in the area previously treated with TARE, at least 6 months after that treatment - Your liver function is adequate (Child-Pugh Class A or B score of 7) - Your general performance status is adequate (ECOG 0–2) - Your blood clotting is normal - You are not pregnant and are using contraception if of childbearing age **You may NOT be eligible if...** - You have previously received external beam radiation to the liver - You have an active unresolved infection - You have had another cancer in the past 5 years - You have had a liver transplant - A radiation oncologist determines carbon ion treatment would be unsafe 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

Carbon ion radiotherapy will be delivered to residual or recurrent hepatocellular carcinoma in patients previously treated with transarterial radioembolization (TARE). Treatment will be administered using hypofractionated high-linear energy transfer radiation, with dose and fractionation individualized based on tumor size, tumor location, and organ-at-risk constraints. The aim of the intervention is to achieve enhanced local tumor control while minimizing toxicity to surrounding normal tissues


Locations(1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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NCT07252323


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