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

Biliary Tract Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558959
• Other study ID #: ZYYYMedOncoBIL01
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2015
• Last updated: February 10, 2018
• Start date: September 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

Drug:
• Irinotecan

• Capecitabine

Locations

Country	Name	City	State
China	First affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	PFS	within 1 year
Secondary	Overall Survival	OS	within 1 year