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)

NCT07252323 | Recruiting

• 1 other identifier: 4-2024-1588
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to mRECIST criteria. Tumor response will be assessed through scheduled imaging studies within 6 months after carbon ion radiotherapy.

  Up to 6 months after completion of carbon ion radiotherapy

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to 3 years after initiation of carbon ion radiotherapy

• Overall Survival (OS)

  Up to 3 years after initiation of carbon ion radiotherapy

• Time to overall tumor progression (TTP)

  Up to 3 years after initiation of carbon ion radiotherapy

• Time to local progression

  Up to 3 years after initiation of carbon ion radiotherapy

• Treatment-related toxicity

  From treatment initiation through 30 days post-treatment, or until the next alternative therapy

Study Arms (1)

Carbon Ion Radiotherapy

EXPERIMENTAL

Participants will receive carbon ion radiotherapy targeting residual or recurrent hepatocellular carcinoma following prior transarterial radioembolization (TARE). Treatment will be delivered using hypofractionated high-linear energy transfer radiation, with dose and fractionation individualized based on tumor size, anatomical location, and organ-at-risk constraints. The intervention aims to provide effective local tumor control while maintaining acceptable safety in patients who have limited subsequent treatment options after TARE.

Radiation: Carbon Ion Radiotherapy

Interventions

Carbon Ion Radiotherapy RADIATION

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

Carbon Ion Radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Hepatocellular

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; no blinding will be applied to participants, investigators, or outcome assessors.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants will receive carbon ion radiotherapy as a single-arm interventional treatment. Outcomes will be evaluated prospectively to assess safety and efficacy in patients with hepatocellular carcinoma previously treated with TARE.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: November 12, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

KR (1)