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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of carbon ion radiotherapy in patients with hepatocellular carcinoma (HCC) who have residual or recurrent disease after prior transarterial radioembolization (TARE). This prospective, single-arm Phase II study aims to see if this advanced radiation treatment can provide better local tumor control while minimizing harm to surrounding healthy tissues. Patients with limited treatment options after TARE are the focus of this investigation. Participants will receive carbon ion radiotherapy targeted at liver tumors, delivered using a hypofractionated, high-linear energy transfer approach. The dose and schedule will be personalized based on tumor size, location, and nearby organ safety limits. This treatment is designed to increase tumor-killing doses while protecting liver function and adjacent gastrointestinal organs. The study does not include a comparison group and focuses on evaluating this single intervention. During the study, patients will undergo baseline assessments and multidisciplinary review before treatment. Follow-up will include scheduled imaging, lab tests, and toxicity monitoring to assess outcomes such as tumor response, progression-free survival, overall survival, and treatment-related side effects. The primary outcome is objective response rate up to 6 months after therapy. Secondary outcomes include survival measures and safety assessed up to 3 years. The study participation may last several years to monitor long-term effects and disease progression.
CONDITIONS
Brief 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
- Diagnosis of hepatocellular carcinoma confirmed by imaging or biopsy
- Presence of residual, recurrent, or progressive tumor in the area treated by prior TARE or nearby liver
- Child-Pugh Class A (score 5-6) or B (score 7) liver function
- Tumors suitable for carbon ion radiotherapy within study treatment limits
- Adequate liver function with minimal treatment exclusion
- AST and ALT levels less than five times the upper limit of normal
- No blood clotting disorders
- ECOG performance status of 2 or lower
- Not pregnant or using appropriate contraception if female 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 past advanced carcinoma within 5 years
- History of liver transplant
- Carbon ion radiotherapy deemed inappropriate or unsafe by a radiologic oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hypofractionated regimens individualized per participant
Participants receive carbon ion radiotherapy targeting residual or recurrent hepatocellular carcinoma following prior transarterial radioembolization (TARE). Treatment is delivered using hypofractionated high-linear energy transfer radiation individualized based on tumor size, location, and organ-at-risk constraints to achieve effective local tumor control while minimizing toxicity.
Treatment visits depending on individualized radiation schedule
Duration - Up to 3 years after initiation of carbon ion radiotherapy
Participants are followed with scheduled imaging, laboratory tests, and toxicity assessments to evaluate tumor response, local control, progression-free survival, overall survival, and treatment-related toxicity.
Scheduled visits for imaging and laboratory tests over follow-up period
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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