NCT04004234

A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC

A Phase I/II, Open-label, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Cancer (BTC)

Interventions

Type	Name	Description
DRUG	Manganese Chloride	Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle
DRUG	nab-paclitaxel	Administered intravenously, 125mg/m2/d on day1 and day8 in a 3-week cycle
DRUG	Gemcitabine	Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
DRUG	anti-PD-1 antibody	Administered intravenously, 2-4mg/kg on day 3 in a 3-week cycle

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-08-31
• Completion: 2021-08-31
• First posted: 2019-07-01
• Last updated: 2019-07-09

Locations

1 site across 1 country: China