Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT01673334 - Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms Phase 4
Recruiting NCT01978808 - Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic Masses N/A
Completed NCT01479803 - Comparison of Two Needles (ProCore vs EchoTip) for the Diagnosis of Pancreatic Solid Mass Under EUS Phase 3
Completed NCT02716207 - Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife N/A
Withdrawn NCT01434550 - Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer N/A
Completed NCT03444051 - Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors N/A
Recruiting NCT05794048 - METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors N/A
Recruiting NCT05871164 - Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
Recruiting NCT01969110 - Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy Phase 4
Completed NCT02330497 - Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor N/A
Completed NCT01692873 - Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors N/A
Recruiting NCT04075305 - The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Recruiting NCT04357483 - Effect of Thrombin-containing Collagen-based Hemostatic Matrix Phase 4
Recruiting NCT01698190 - Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions N/A
Completed NCT03340844 - Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors N/A
Withdrawn NCT02534246 - Head to Head Comparison of Two Needles EUS Guided FNB N/A
Not yet recruiting NCT01819961 - Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery Phase 4
Withdrawn NCT02269683 - Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer N/A