JPRN-UMIN000036449
Completed
Phase 2
Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy - KHBO1901
Kansai Hepatobiliary Oncology Group (KHBO)0 sites106 target enrollmentApril 17, 2019
Conditionsbiliary tract cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- biliary tract cancer
- Sponsor
- Kansai Hepatobiliary Oncology Group (KHBO)
- Enrollment
- 106
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)Distant metastasis except of positive CY 2\) Not performed lobectomy 3\) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease\-free interval of 3 years or shorter, excluding lesions consistent with intraepithelial cancer, i.e., intramucosal cancer that are assessed as cured by endoscopical treatment.) 4\) Patients with a history of severe drug hypersensitivity or drug allergy. 5\) Serious complicating disorders (Interstitial pneumonia, pulmonary fibrosis or severe emphysema, hepatic cirrhosis, uncontrollable\-diabetes, cardiac disease, renal failure, liver failure, hemorrhagic peptic ulcer etc). 6\) Active infection requiring systemic therapy 7\) Pregnant or lactating women, women with childbearing potential, males males who wish a pregnancy of his partner. 8\) Severe psychiatric disease. 9\) Inappropriate for this study judged by the attending physician
Outcomes
Primary Outcomes
Not specified
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