Clinical trial · Interventional
XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
NCT02350686CI-TRIAL-00038702unknownPhase 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)
Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.
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 Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- capecitabine+oxaliplatin
- description
- XELOX every 3 weeks
- interventionNames
- Drug: capecitabine
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 12months
Secondary outcomes (4)
- measure
- response rate
- timeFrame
- 12months
- measure
- duration of response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥ 18 2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer) 3. unresectable or metastatic 4. progression after treatment with first line gemcitabine-based chemotherapy 5. ECOG performance status of 0\~2 6. measurable or evaluable lesion per RECIST 1.1 criteria 7. adequate marrow, hepatic, renal and cardiac functions Exclusion Criteria: 1. severe co-morbid illness or active infections 2. pregnant or lactating women 3. History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia 4. active CNS metastases not controllable with radiotherapy or corticosteroids 5. known history of hypersensitivity to study drugs
References
Publications (0)
Data not yet available
No reference posted for this study.