Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer

Biliary Tract Neoplasm Clinical Trial

Official title: Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer

Status Active, not recruiting

Clinical Trial Summary

This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.

Clinical Trial Description

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.

S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study. ;

Related Conditions & MeSH terms

• Biliary Tract Neoplasm
• Biliary Tract Neoplasms

• NCT number: NCT02527824
• Study type: Interventional
• Source: Hallym University Medical Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2015
• Completion date: September 2017