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

NCT04810910 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-11-16

No results posted yet for this study

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

BIOLOGICAL

iNeo-Vac-P01

iNeo-Vac-P01 (peptides)： 300 mcg per peptide

OTHER

GM-CSF

GM-CSF: 40 mcg

Sponsors & Collaborators

  • Hangzhou Neoantigen Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Zhejiang Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Yang Liu, Liu · Zhejiang Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2025-03-30
Completion
2025-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810910 on ClinicalTrials.gov