Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer

A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

Inclusion Criteria:

• Histological or cytological diagnosis of biliary tract cancer
• Measurable disease must be at least one lesion
• Chemotherapy-naïve
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Estimated life expectancy no less than 3 months

Exclusion Criteria:

• radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia