Overview

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

Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Chinese PLA General Hospital
Treatments:
Albumin-Bound Paclitaxel
Antibodies
Gemcitabine
Immune Checkpoint Inhibitors
Immunoglobulins
Manganese
Paclitaxel