Carbon ion radiotherapy for liver cancer that returned after TARE
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)
This trial will try carbon ion radiotherapy to control liver tumors in people whose hepatocellular carcinoma persisted or came back after TARE.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07252323 on ClinicalTrials.gov |
What this trial studies
This single-arm Phase II study enrolls patients with imaging- or biopsy-confirmed hepatocellular carcinoma who have residual or recurrent lesions in areas previously treated with transarterial radioembolization (TARE). Eligible participants receive hypofractionated carbon ion radiotherapy with individualized planning to maximize tumor dose while sparing normal liver and nearby organs. Follow-up includes scheduled imaging, laboratory tests, and toxicity assessments using CTCAE, and outcomes include objective response rate, local control, progression-free survival, and overall survival. The goal is to see whether dose-escalated carbon ion treatment can achieve effective local tumor control with acceptable safety as a salvage option after TARE.
Who should consider this trial
Good fit: Adults over 19 with imaging- or histology-confirmed hepatocellular carcinoma who have residual or recurrent lesions in the TARE-treated area, preserved liver function (Child-Pugh A or B7), ECOG performance status ≤2, acceptable labs (AST/ALT <5× ULN, no significant coagulopathy), and lesions suitable for carbon ion delivery are the intended candidates.
Not a fit: Patients with poor liver function (Child-Pugh class C or >B7), widespread metastatic disease, tumors not safely targetable by carbon ion beams, significant coagulopathy, or serious comorbid illnesses are unlikely to benefit.
Why it matters
Potential benefit: If successful, carbon ion radiotherapy could provide improved local tumor control with limited damage to healthy liver, offering a viable salvage option after TARE.
How similar studies have performed: Small institutional series report promising local control with carbon ion radiotherapy for HCC, but robust, large-scale evidence—particularly for use after TARE—is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients over the age of 19 Hepatocellular carcinoma patients confirmed imagingly or histologically Patients who have a residual lesion in the TARE-treated area or have a recurrence or progressive lesion in the TARE-treated area or nearby liver and are deemed to need additional treatment when evaluating the response for more than 6 months Child-Pugh Class A (Child-Pugh score 5-6), B (CP score 7) Patients who fall within the range of lesions that can afford the baryon treatment intended in this study Patients who have minimal availability of liver excluded from treatment in terms of preservation of liver function proper liver function Patients with AST/ALT less than 5 times the upper limit of normal If you don't have blood clotting disorder ECOG performance status 2 or lower Patients who are not pregnant or who are undergoing appropriate contraception for women of childbearing age No other underlying conditions that seriously affect survival Patients who have listened to and agreed to a documented explanation and a statement of consent Exclusion Criteria: * If you've had external radiotherapy in your liver Patients with unresolved infections at that point Patients who have a current or other history of advanced carcinoma within 5 years a patient who underwent a liver transplant If baryon treatment is inappropriate or dangerous under the judgment of a radiologic oncologist
Where this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.