Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)

Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER) - Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020444

Enrollment

130

Registered

2016-01-10

Start date

2016-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Carbon-ion radiation therapy 60 Gy(RBE) / 4 fractions 60 Gy(RBE) / 12 fractions (adjacent to organ at risk)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or clinically diagnosed primary hepatocellular carcinoma. 2) Untreated and absence of previous local therapy. 3) Solitary tumor without extrahepatic lesions. 4) The tumor is measurable and tumor size is less than 12 cm. 5) Absence of major portal vein and/or hepatic vein. 6) The tumor is in contact with the alimentary tract. 7) Unfit for resection or liver transplantation. 8) Unfit for percutaneous tumor ablation. 9) ECOG PS: 0-2. 10) Child-Pugh score of the patient is from 5 points to 9 points. 11) Absence of uncontrolled ascites and/or pleural effusion. 12) 20-year-old or older. 13) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Exclusion criteria

Exclusion criteria: 1) Patients with any other active malignancies. 2) Having esophageal varices which are at great risk of bleeding 3) Having active infectious diseases 4) Having a fever greater than 38 degrees Celsius. 5) Having myocardial infarction or angina pectoris within 6 months. 6) Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema. 7) Having radiation hypersensitivity. 8) Associated with mental illness or manifestation complicating study participation. 9) Being pregnant or possible conception. 10) Miscellaneous inappropriate conditions judged by physicians.

Design outcomes

Primary

Measure	Time frame
Overall survival (Three-year overall survival)	—

Secondary

Measure	Time frame
Progression free survival (Three-year), Local progression free survival (Three-year), Adverse event, Incidence of radiation-induced liver disease(RILD)	—

Countries

Japan

Contacts

Public ContactKei Shibuya

Gunma University Heavy Ion Medical Center

tohno@gunma-u.ac.jp027-220-8378

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026