Clinical trial · Interventional
GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer
Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer
NCT02182778CI-TRIAL-00037198completedPhase 3ClinicalTrials.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 validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable 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 Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine/Cisplatin | Drug | — | UNRESOLVED |
| Gemcitabine/Cisplatin /S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine/Cisplatin group
- description
- Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
- interventionNames
- Drug: Gemcitabine/Cisplatin /S-1
- type
- EXPERIMENTAL
- label
- Gemcitabine/Cisplatin /S-1 group
- description
- S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
- interventionNames
- Drug: Gemcitabine/Cisplatin
Primary outcomes (1)
- measure
- Overall survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with cytologically or histologically proved biliary tract cancer 2. age \>=20 years 3. Performance Status (PS) 0-2 4. No prior history of chemotherapy or radiotherapy. 5. Adequate bone marrow function (neutrophil count \>=1,500/mm3, and platelet count \>=100,000/mm3), liver function (total bilirubin \>=3 mg/dL and AST/ALT \>=150 IU/L), and renal function (creatinine clearance \>=45 mL/min) 6. Adequate oral intake 7. Provided written informed consent - Exclusion Criteria: 1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients with moderate or marked pleural effusion or ascites necessitating drainage 5. Patients with a history of severe drug allergy 6. Patients with other serious comorbid disease 7. Patients who are pregnant or lactating, or have an intention to get pregnant 8. Patients with mental disease 9. Patients who are judged inappropriate for the entry into the study by the principle doctor \-
References
Publications (2)
- DERIVEDIoka T, Kanai M, Kobayashi S, Sakai D, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Takahashi M, Sho M, Kamei K, Fujimoto J, Toyoda M, Shimizu J, Goto T, Shindo Y, Yoshimura K, Hatano E, Nagano H; Kansai Hepatobiliary Oncology Group (KHBO). Randomized phase III study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401- MITSUBA). J Hepatobiliary Pancreat Sci. 2023 Jan;30(1):102-110. doi: 10.1002/jhbp.1219. Epub 2022 Aug 9. PMID 35900311
- DERIVEDKanai M, Hatano E, Kobayashi S, Fujiwara Y, Marubashi S, Miyamoto A, Shiomi H, Kubo S, Ikuta S, Yanagimoto H, Terajima H, Ikoma H, Sakai D, Kodama Y, Seo S, Morita S, Ajiki T, Nagano H, Ioka T. A multi-institution phase II study of gemcitabine/cisplatin/S-1 (GCS) combination chemotherapy for patients with advanced biliary tract cancer (KHBO 1002). Cancer Chemother Pharmacol. 2015 Feb;75(2):293-300. doi: 10.1007/s00280-014-2648-9. Epub 2014 Dec 5. PMID 25477010