Clinical trial · Interventional
Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer
Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
NCT01096745CI-TRIAL-00005061terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Planning for randomized phase III trial for this issue.
Summary
Brief summary (as posted)
The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Cisplatin | Drug | — | UNRESOLVED |
| S-1, Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine/Cisplatin
- interventionNames
- Drug: Gemcitabine, Cisplatin
- type
- EXPERIMENTAL
- label
- S-1/Cisplatin
- description
- D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
- interventionNames
- Drug: S-1, Cisplatin
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age : older than 20 * Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 * Histologically confirmed adenocarcinoma of the biliary tract * Metastatic or unresectable biliary cancer * No prior chemotherapy for biliary cancer * A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT) * Adequate bone marrow, liver, renal function Exclusion Criteria: * A patient with no measurable disease * A patient who received previous palliative chemotherapy for biliary cancer * A patient who received adjuvant chemotherapy for biliary cancer within 1year * A patient with previous active or passive immunotherapy. * A pregnant or lactating patient
References
Publications (0)
Data not yet available
No reference posted for this study.