Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer
Biliary tract cancer is one of the most lethal malignancies worldwide, with surgery
representing the only potentially curative treatment for this disease. However, many
patients are diagnosed too late for curative resection, and even if surgery can be
performed, the likelihood of relapse is very high. Over the past decade, gemcitabine has
been widely used to treat unresectable or recurrent biliary tract cancer patients. In the
ABC-02 study, the first prospective multicenter phase III study in this field,
gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and
found that the combination regimen significantly prolonged MST (from 8.1 to 11.7 months; P <
0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard
regimen for advanced biliary tract cancer. S-1 is an oral fluoropyrimidine prodrug that has
confirmed efficacy against various solid tumors, both alone and in combination with other
cytotoxic drugs. S-1 monotherapy has yielded good results against advanced biliary tract
cancer and gemcitabine/S-1 combination therapy has yielded promising results with acceptable
toxicity levels for patients with advanced biliary tract cancer. In this study, we aimed to
determine the safety and efficacy of adding S-1 to gemcitabine/cisplatin combination regimen
for advanced biliary tract cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
one year survival rate
The primary endpoint is designated to evaluate overall survival rate at 12-month. Secondary endpoints include response rate according to RECIST 1.1 and the incidence of adverse events evaluated by CTCAE v 4.0.
2 years
Yes
Etsuro Hatano, MD, PhD
Study Director
Kyoto University
Japan: Institutional Review Board
KHBO1002
NCT01284413
December 2010
August 2013
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