Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor

Pancreatic Tumor Clinical Trial

Official title: Clinical Trial to Evaluate Safety and Effect of Personalized Neoantigen Vaccine for Pancreatic Tumor Following Surgical Resection and Adjuvant Chemotherapy

Status Recruiting

Clinical Trial Summary

This clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction algorithm, in patients with pancreatic ductal adenocarcinoma. The hypothesis of this study is that personalized neoantigen vaccines will be safe and can systemically elicit measurable neoantigen-specific immunologic responses in patients. Participants will receive complete macroscopic resection of primary tumor, standard adjuvant chemotherapy and subsequently personalized neoantigen vaccines.

Clinical Trial Description

This is a single-center, open-label Phase Ib clinical trial. In this trial, adult subjects with pancreatic ductal adenocarcinoma who have completed resection of the primary tumor and who have not undergone preoperative chemotherapy will be enrolled in the study. Eligible enrolled patients all will undergo tumor resection and all receive adjuvant chemotherapy prior to preparation of the personalized neoantigen vaccine. After the chemotherapy finish, subsequently patients will receive a priming immunization with five doses of the personalized neoantigen vaccine over one month and a boosting immunization with two doses three months later. This clinical trial will examine the safety and effect of the personalized neoantigen vaccine when given at several different time points and will examine the participant's peripheral blood cells for signs that the vaccine induces immunologic responses. Finally we will establish the typical flow to assess efficiency and safety of vaccines according to the different reactivity of patients, as a result, to explore the most suitable practical approaches for applying personalized pancreatic tumor vaccines. ;

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Pancreatic Tumor

• NCT number: NCT03558945
• Study type: Interventional
• Source: Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
• Contact: Shiwei Guo, Doctor
• Phone: +8618621500666
• Email: gestwa@163.com
• Status: Recruiting
• Phase: Phase 1
• Start date: July 12, 2018
• Completion date: December 30, 2023