Spots Global Cancer Trial Database for Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs
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Trial Identification
Brief Title: Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs
Official Title: A Pilot Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers
Study ID: NCT03311789
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Biotherapeutic, Chinese PLA General Hospital, Beijing, , China
Contact Details
Name: Weidong Han, Ph.D
Affiliation: Department of Biotherapeutic, Chinese PLA General Hospital
Role: STUDY_DIRECTOR
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