drugset / Trial / NCT04004234
A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2020-08-31
- Completion
- 2021-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1 g | Intravenous |
| Subject | Manganese Chloride | Other / unclassified | 0.2 mg/kg | Other |
| Subject | Manganese Chloride | Other / unclassified | 0.4 mg/kg | Other |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Pidilizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Pidilizumab | Monoclonal antibody | 4 mg/kg | Intravenous |