Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study

This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.

Inclusion Criteria:

• Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
• Age 18 years or older
• Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
• Karnofsky performance status (KPS) of at least 70%
• Adequate renal function, adequate hepatic function, adequate bone marrow function

Exclusion Criteria:

• The presence of any severe concomitant disease that could interrupt the planned treatment
• Intractable pain
• Hypersensitivity to study drugs
• Serious cardiovascular disease
• If female, pregnancy or breastfeeding