Clinical Study Of MRNA Vaccine Combined With PD-1 Inhibitor As Adjuvant Therapy For Postoperative Pancreatic Cancer

Study Overview

Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer

This study primarily aims to assess the safety and tolerability of XP-004 personalized mRNA vaccines encoding tumor neoantigens combined with PD-1 inhibitor as adjuvant therapy for chemotherapy-intolerant patients following radical pancreatic cancer resection. Secondary objectives focus on evaluating preliminary efficacy through three parameters: 1) XP-004-induced antigen-specific CD4+/CD8+ T cell activation levels, 2) recurrence-free survival (RFS), and 3) overall survival (OS) in post-operative pancreatic cancer patients receiving this combination therapy.

N/A

Pancreatic Cancer Resectable
Chemotherapy-intolerant

BIOLOGICAL: Fixed neoantigen tumor vaccine
BIOLOGICAL: personalized neoantigen tumor vaccine
DRUG: PD-1 inhibitor

2023PCV004

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-06-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-26
First Submitted that Met QC Criteria 2024-07-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-01
First Posted (ACTUAL) 2024-07-11	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Neoantigen based vaccines + PD-1 inhibitor A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.	BIOLOGICAL: Fixed neoantigen tumor vaccine Single/Fixed neoantigen mRNA vaccine includes pancreatic cancer driver mutations such as KRAS G12D, G12V, G12R, G12C, etc. Each vaccine has one neoantigen encoded by mRNA. Total of 4 cycles, 3 weeks each cycle. BIOLOGICAL: personalized neoantigen tumor vaccine personalized neoantigen tumor vaccine include 5-20 neoantigens selected based on WES/RNA-seq of patients' tumor sample during surgery. Total of 9 cycles after finishing the first 4 cycles of fixed neoantigen tumor vaccine. DRUG: PD-1 inhibitor Toripalimab

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Neoantigen based vaccines + PD-1 inhibitor

A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.

BIOLOGICAL: Fixed neoantigen tumor vaccine

Single/Fixed neoantigen mRNA vaccine includes pancreatic cancer driver mutations such as KRAS G12D, G12V, G12R, G12C, etc. Each vaccine has one neoantigen encoded by mRNA. Total of 4 cycles, 3 weeks each cycle.

BIOLOGICAL: personalized neoantigen tumor vaccine

personalized neoantigen tumor vaccine include 5-20 neoantigens selected based on WES/RNA-seq of patients' tumor sample during surgery. Total of 9 cycles after finishing the first 4 cycles of fixed neoantigen tumor vaccine.

DRUG: PD-1 inhibitor

Toripalimab

Primary Outcome Measures	Measure Description	Time Frame
Drug related toxicity	Percentage Participants with Adverse Events (AEs) by severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	18 months

Secondary Outcome Measures	Measure Description	Time Frame
Recurrence-free survival (RFS)	Recurrence-free survival of Personalized mRNA Tumor Vaccine	Up to 18 months
overall survival (OS)	Overall Survival of Personalized mRNA Tumor Vaccine	Up to 18 months
Reaction of antigen-specific T cells in peripheral blood	personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses	Up to 18 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xinjing Wang

Phone Number: 18817821319

Email: newvista89@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Shanghai Xinpu BioTechnology Company Limited

Investigators

STUDY_DIRECTOR: Baiyong Shen, M.D&Ph.D, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record