Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma

Phase 2

Recruiting

• Conditions: Hepatocellular carcinoma; Hepatocellular carcinoma, Unresectable; D006528

• Registration Number: JPRN-jRCT1032200036
• Lead Sponsor: Ohno Tatsuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (Three-year overall survival)

Secondary Outcome Measures

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