Objective Primary: Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen Secondary: Determine time to progression-free survival and overall survival of patients treated with this regimen. Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen
Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study Chemotherapy regimen: Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST(somatostatin) Cycles repeat every 4 weeks and 6 cycles in total Patients: A total of 260 patients (130 per group) will be accrued for this study. Patients distribution: 10patients per center are enrolled in the study and 30 centers (hospitals) in total which meet the total number of patients in trial. Clinical Outcome Assessments: Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST criteria) Secondary: progression-free survival, overall survival, quality of life,the adverse event Safety Assessments: Physical exam, laboratory test, probably occurred adverse event.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Somatostatin 3mg+NS(normal saline)60ml, a continuous intravenous infusion, q12h
Xinhua hospital affiliated shanghai jiaotong
Shanghai, China
(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
Time frame: 6 month after first treatment
A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9(Carbohydrate Antigen 19-9)、 CEA( carcinoembryonic antigen), especially for those which are abnormal prior to chemotherapy
Time frame: 6 month after first treatment
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