A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment,
Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional
regimen plus SST 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.
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 (RECIST criteria) Secondary: progression-free survival,
overall survival, quality of life，the adverse event
Physical exam, laboratory test, probably occurred adverse event.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Evaluation Criteria in Solid Tumors, RECIST,2009 CR and PR
Zhi-wei Quan, MD
Xinhua hospital affiliated shanghai jiaotong university school of medicine
China: Food and Drug Administration