Clinical trial · Interventional
Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer
Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
NCT02527824CI-TRIAL-00029219unknownPhase 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 will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.
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 Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, Irinotecan, S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxaliplatin, Irinotecan, S-1(OIS)
- description
- intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle. 1. Oxaliplatin 65 mg/m2 iv on day 1 2. Irinotecan 135 mg/m2 iv on day 1 3. S-1 80 mg/m2/day on day 1-7
- interventionNames
- Drug: Oxaliplatin, Irinotecan, S-1
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 1.5 year
- description
- Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
Secondary outcomes (3)
- measure
- progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * More than 3 months expected life span * Measurable lesion by RECIST criteria version 1.1 * Palliative chemotherapy naive * Adequate organ functions * Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: * Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer. * Participants who had received radiation therapy for target lesions 4 weeks before study enrollment * Participants who had received major surgery 4 weeks before study enrollment * Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding * Participants with central nervous system(CNS) metastases * Participants with peripheral sensory neuropathies with impaired functional activities * Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.
References
Publications (0)
Data not yet available
No reference posted for this study.