Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
- Registration Number
- NCT02558959
- Lead Sponsor
- Zhejiang University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Irinotecan and Capecitabine Irinotecan irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w Irinotecan and Capecitabine Capecitabine irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w Irinotecan Irinotecan irinotecan 180mg/m2 d1, q2w
- Primary Outcome Measures
Name Time Method Progression Free Survival within 1 year PFS
- Secondary Outcome Measures
Name Time Method Overall Survival within 1 year OS
Trial Locations
- Locations (1)
First affiliated hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
First affiliated hospital, Zhejiang University🇨🇳Hangzhou, Zhejiang, China