Health Condition 1: C221- Intrahepatic bile duct carcinoma Health Condition 2: C23- Malignant neoplasm of gallbladder Health Condition 3: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 4: C241- Malignant neoplasm of ampulla of Vater
Conditions
Interventions
Intervention1: Gemcitabine, cisplatin and S1: Arm B (Experimental Arm)
Gemcitabine + Cisplatin + S-1
Gemcitabine: 1000 mg/m IV on days 1
Cisplatin: 25 mg/m IV on days 1
S-1: Oral, dose based o
Sponsors
Tata Memorial Centre Research Administration Council (TRAC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years at the time of enrolment. 2. Histologically or cytologically confirmed biliary tract carcinoma, including: Intrahepatic cholangiocarcinoma, Extrahepatic cholangiocarcinoma, Gallbladder carcinoma, Ampullary carcinoma 3. Unresectable locally advanced or metastatic disease, not amenable to curative surgery or locoregional therapy. 4. Measurable disease as per RECIST version 1.1. 5. ECOG performance status 0 1 6. No prior systemic chemotherapy 7. Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) greater than 1500 cells per mm3 Platelet count greater than 1 lakh per mm3 Hemoglobin greater than 9 g per dL 8. Adequate hepatic function: Total bilirubin less than 1.5 upper limit of normal (ULN) AST and ALT less than 2.5 ULN (less than 5 ULN if liver metastases present) 9. Adequate renal function o Serum creatinine less than or equals to 1.5 ULN or o Creatinine clearance greater than or equal to 60 mL per min (Cockcroft Gault) 10. Informed consent
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy for metastatic or unresectable biliary tract cancer. 2. Prior treatment with immune checkpoint inhibitors or targeted therapy 3. Uncontrolled or significant comorbid illnesses, including: Uncontrolled cardiac disease, Active uncontrolled infection, Severe pulmonary disease 4. Known brain metastases or leptomeningeal disease 5. Renal impairment: Creatinine clearance less than 60 mL per min, Requirement for dialysis 6. Severe hepatic dysfunction, including: Child Pugh class C liver disease, Uncontrolled obstructive jaundice despite biliary drainage 7. Active second malignancy 8. Pregnant or lactating women. 9. Known dihydropyrimidine dehydrogenase (DPD) deficiency. 10. Psychiatric illness or social situation that would interfere with study compliance or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the objective response rate between patients with advanced and metastatic biliary tract cancers treated with gemcitabine, cisplatin and S1 with gemcitabine and cisplatinTimepoint: To compare the objective response rate between patients with advanced and metastatic biliary tract cancers treated with gemcitabine, cisplatin and S1 with gemcitabine and cisplatin. Evaluate objective response rate and other measures at baseline and every 12 weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare Progression Free Survival (PFS) between the two treatment arms 2. To evaluate & compare 1-year overall survival (OS) in the two study groups 3. To compare the Disease control rate (DCR) between the two treatment groups 4. To assess & compare the Safety & tolerability of two treatment groupsTimepoint: 1 Year OS Time from the date of registration to death from any cause within 1-year period of time PFS Time from the date of registration to tumor progression or death from any cause whichever came first. DCR The proportion of patients with complete response, partial response, or stable disease (SD). Safety & Toxicity Profile Incidence & severity of adverse events graded according to CTCAE. Evaluate all the secondary endpoints every 12 weekly. | — |
Countries
India
Contacts
Public ContactNirmalkumar Ramachandran
Homi Bhabha Cancer Hospital and Research Centre
Outcome results
None listed