NCT04810910

Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy. It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Conditions

• Resectable Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	iNeo-Vac-P01	iNeo-Vac-P01 (peptides)： 300 mcg per peptide
OTHER	GM-CSF	GM-CSF: 40 mcg

Timeline

• Start date: 2021-03-30
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2021-03-23
• Last updated: 2021-11-16

Locations

1 site across 1 country: China