Pembrolizumab in Biliary Tract Cancer

Open-label First Line, Single-arm Phase II Study of CisGem Combined With Pembrolizumab in Patients With Advanced or Metastatic Biliary Tract Cancer

This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab. Secondary objectives are: Assess the treatment efficacy in terms of overall survival, immune related progression-free survival, response rate (according to RECIST version 1.1), safety, symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21) Exploratory objectives include assessment of immunological response (cytokines, lymphocyte phenotype, immunoglobulins), and evaluation of pathological and clinical predictive factors for response/toxicity Translational research will focus on biomarkers for prediction of response and toxicity.

Pembrolizumab in Biliary Tract Cancer

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