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

To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.

Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.

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

   -