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

Zhejiang University

Status and phase: Completed; Phase 2

Conditions: Biliary Tract Neoplasms

Treatments: Drug: Irinotecan; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02558959

ZYYYMedOncoBIL01

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Irinotecan and Capecitabine

Experimental group

Description:

irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w

Treatment:

Drug: Irinotecan

Drug: Capecitabine

Irinotecan

Active Comparator group

Description:

irinotecan 180mg/m2 d1, q2w

Treatment:

Drug: Irinotecan