Estudo Clínico de Fase II, Randomizado, Avaliando a combinação de Cisplatina e Irinotecano no Tratamento de Primeira Linha do Carcinoma da vesícula Biliar, Vias Biliares Intra ou Extra-hepáticas irressecável ou metastático (ESTUDO GAMBIT) (GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
The overall response rate will measure the number of subjects with complete or partial response as best response during the entire treatment, over the total number of subjects, for each arm. The response will be evaluated according to RECIST 1.1.
Up to 24 weeks from randomization
Lucas V dos Santos, MD
Barretos Cancer Hospital
Brazil: Comite Nacional de Ética em Pesquisa CONEP