Actively Recruiting
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)
Led by Yonsei University · Updated on 2025-11-26
48
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 years or older
- Hepatocellular carcinoma confirmed by imaging or histology
- Residual, recurrent, or progressive lesion in or near the area treated by TARE requiring additional treatment after more than 6 months
- Child-Pugh Class A (score 5-6) or B (score 7) liver function
- Lesions suitable for carbon ion radiotherapy as planned in this study
- Adequate liver function with minimal liver volume excluded from treatment
- AST and ALT less than 5 times the upper limit of normal
- No blood clotting disorder
- ECOG performance status of 2 or lower
- Not pregnant or using appropriate contraception if of childbearing potential
- No other serious underlying conditions affecting survival
- Provided informed consent after explanation
You will not qualify if you...
- Prior external radiotherapy to the liver
- Unresolved infections at screening
- Current or history of advanced carcinoma within 5 years
- History of liver transplant
- Judged by a radiologic oncologist as unsuitable or unsafe for carbon ion radiotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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