Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study.

ABSTRACT:

Background & aims

Gemcitabine plus cisplatin (GC) remains the standard, frontline therapy for advanced biliary tract cancer (ABTC). The JCOG1113 study suggested that gemcitabine plus S-1 (GS) had noninferior median overall survival and comparable incidence of significant neutropenia as compared to GC treatments. This study evaluates the efficacy and safety of a modified GS regimen.

Methods

The eligible patients with chemonaive, measurable ABTC received 800 mg/m² of gemcitabine on day 1 and 80 mg/m² /day of S-1 (80/100/120 mg for patients with body surface <1.25/ ≥1.25 and <1.5/ ≥1.5 m² respectively). The primary endpoint was the 12-week disease control rate (12-week DCR: objective response and stable disease ≥ 12 weeks). Per the p0 = 40% and

SUBMITTER: Chiang NJ 

PROVIDER: S-EPMC7540301 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature