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

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Camptothecin; Capecitabine; Cisplatin; Gemcitabine; Irinotecan

Criteria

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