Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Phase 2
Recruiting
- Conditions
- hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000020444
- Lead Sponsor
- Gunma University Heavy Ion Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
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)