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Clinical Trial Summary

Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04004234
Study type Interventional
Source Chinese PLA General Hospital
Contact Weidong Han
Phone 86(10)66937463
Email hanwdrsw@sina.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 1, 2019
Completion date August 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05036486 - The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Completed NCT03314935 - A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors Phase 1/Phase 2
Terminated NCT03790111 - A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer Phase 2