Overview

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