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,
Safety/Efficacy Study
Chemotherapy regimen:
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.
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 (RECIST criteria) Secondary: progression-free survival,
overall survival, quality of life,the adverse event
Safety Assessments:
Physical exam, laboratory test, probably occurred adverse event.
Interventional
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
6 month
Yes
Zhi-wei Quan, MD
Study Chair
Xinhua hospital affiliated shanghai jiaotong university school of medicine
China: Food and Drug Administration
xh2009-35
NCT01053390
October 2009
June 2015
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