Clinical trial · Interventional
A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis
A Multicenter Phase II Trial of Preoperative Chemotherapy With Gemcitabine/ Cisplatin /S-1 (GCS) for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
NCT01821248CI-TRIAL-00037212unknownPhase 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)
To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Cisplatin, S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, Cisplatin, S-1
- description
- 1000mg/m2/day1, 25mg/m2/day1, 100mg/body/day1-7
- interventionNames
- Drug: Gemcitabine, Cisplatin, S-1
Primary outcomes (1)
- measure
- Curative resection rate
- timeFrame
- 14weeks
- description
- The primary endpoint is designated to evaluate curative resection rate after preoperative chemotherapy with GCS for Biliary Tract Cancers with lymph node metastasis diagnosed by FDG-PET.
Secondary outcomes (1)
- measure
- Response rate and toxicity
- timeFrame
- 10 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with radiologically proven biliary tract cancer. 2. No extra-hepatic disease. 3. No prior therapy. 4. The function of the liver is kept as satisfied after hepatectomy. 5. No chronic liver damage. 6. Patients of age over 20 years. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 8. Sufficient organ function (neutrophil count \>=1,500/mm3 and platelet count \>=100,000/mm3, Hemoglobin \>=9.0g/dL, Aspartate transaminase (AST)/alanine aminotransferase (ALT) \<=150 IU/L, total bilirubin \<=1.5 mg/dL , creatinine \<=1.2 mg/dL , creatinine clearance \>=60 mL/min) 9.Patients obtained written informed consent. Exclusion Criteria: 1. Massive abdominal effusion requiring treatment. 2. Active concomitant malignancy. 3. The case suspected of infection. 4. Patients with water solubility diarrhea. 5. Mental disease or psychotic manifestation. 6. Under continuous steroid therapy. 7. Patients with acute myocardial infarction. 8. Patients with severe complications. 9. Pregnancy or the desire to preserve fecundity. 10. Serious drug hypersensitivity or a history of drug allergy. 11. Any patients judged by the investigator to be unfit to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.