Biliary Tract Cancer Clinical Trial
Official title:
A Pilot Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers
This is a single-arm, phase I/II trial in biliary tract cancer (BTC) patients. The purpose of
this trial is to evaluate the safety and effect of PD-1 inhibitor in combination with
gemcitabine/cisplatin chemotherapy in patients with advanced unresectable or metastatic BTCs.
The primary objective: 6-month progression free survival (PFS). The second objectives:
objective clinical response(according to RECIST version 1.1), safety, symptom control and
quality of life (QoL) (according to EORTC QoL C30 and BIL 21), overall survival. The
exploratory objectives: assessment of immunological response (cytokines, lymphocyte
phenotype, immunoglobulins), and evaluation of pathological, immunological and clinical
predictive factors for response/toxicity.
n/a
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