NCT03989310

An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The outcome of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen, but the response rate is unacceptably low. 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 one-arm, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and chemotherapy.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Manganese Chloride	Administered by inhalation at 0.4mg/kg twice per week in a 3-week cycle
DRUG	nab-paclitaxel	Administered intravenously, 200mg/d on day 1 and day 8 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 2 in a 3-week cycle

Timeline

• Start date: 2019-03-01
• Primary completion: 2021-05-31
• Completion: 2022-03-31
• First posted: 2019-06-18
• Last updated: 2020-12-23

Locations

1 site across 1 country: China