NCT06326736

Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

An Exploratory Clinical Study of Safety and Efficacy of Neoantigen mRNA Vaccines in the Treatment of Patients With Resectable Pancreatic Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.

Detailed description

The first purpose of this study is to evaluate the safety of treating pancreatic cancer with surgery to remove cancerour tissue. Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgery	Tumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
DRUG	Camrelizumab	Camrelizumab will be administered 6 weeks post-tumor resection.
BIOLOGICAL	SJ-Neo006	SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).
DRUG	Gemcitabine+Abraxane	Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

1 site across 1 country: China