Clinical trial · Interventional
Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
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
NCT02558959CI-TRIAL-00031657completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Irinotecan and Capecitabine
- description
- irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
- interventionNames
- Drug: Irinotecan
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan
- description
- irinotecan 180mg/m2 d1, q2w
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- within 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.