drugset / Trial / NCT01713387

A Phase I Study of Adjuvant Chemotherapy With GS in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

NCT01713387

Phase 1 Completed 38 enrolled Kansai Hepatobiliary Oncology Group
NaSingle-groupOpen-labelTreatment

Summary

To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus S-1 combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy

Timeline

Start
2012-04
Primary completion
2015-04
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 800 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject S-1 Small molecule 50 mg/m2 Oral
Subject S-1 Small molecule 65 mg/m2 Oral
Subject S-1 Small molecule 80 mg/m2 Oral

Indications