Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer,
because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy.
For example, our preliminary results showed that regular gemcitabine administration
(1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced
severe leukocytopenia and/or thrombocytopenia. Herein, we planned this study to decide more
safety adjuvant protocol(recommend dose) for gemcitabine and S-1 after hemihepatectomy using
continual reassessment method analysis. In this study, we decided that tolerable ratio of
dose-limiting toxicity would be less than 10%.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
frequency in adverse events
The purpose of this study is to decide maximum tolerated dose and recommended dose. Recommended dose is a dose which would induce dose-limiting toxicity in 10% of participants. This will be calculated by continual reassessment method.
up to 12 weeks
Hiroaki Nagano, MD, PhD
Osaka University, Graduate School of Medicine
Japan: Institutional Review Board