A phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer.
Phase 2
- Conditions
- unresectable gallbladder cancer
- Registration Number
- JPRN-UMIN000002824
- Lead Sponsor
- Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria in this study are as follows: 1. Interstitial pneumonitis, pulmonary fibrosis with radiological findings 2.Presence of uncontrolled diabetes, severe liver dysfunction, unstable angina, myocardial infarction within three months. 3.Presence of active severe infection 4.Pregnant, lactating women or women with suspected pregnancy. 5.Medical history of severe hypersensitivity. 6.Severe complications 7.Inappropriate patients for this study judged by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method survival time, progression-free survival time, safety, performance status