RecruitingEarly Phase 1NCT06326736

Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

An Exploratory Clinical Study of Safety and Efficacy of Neoantigen mRNA Vaccines in the Treatment of Patients With Resectable Pancreatic Cancer


Sponsor

Jinling Hospital, China

Enrollment

12 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests personalized mRNA cancer vaccines for people with pancreatic cancer that can be surgically removed. After surgery, the vaccine is custom-made using mutations unique to a patient's tumor (called neoantigens) to train the immune system to find and destroy remaining cancer cells. The goal is to reduce the chance of the cancer coming back. **You may be eligible if...** - You are 18 or older - You have pancreatic cancer that appears surgically removable on imaging - Your cancer is confirmed as pancreatic ductal adenocarcinoma after surgery - You have not had chemotherapy, radiation, or immunotherapy before for this cancer - Your general health status is good (ECOG 0 or 1) - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - Your cancer cannot be completely removed surgically - You have had prior cancer treatment for pancreatic cancer - You have significant organ problems that would prevent safe participation - You have certain autoimmune or immune system conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgery

Tumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.

DRUGCamrelizumab

Camrelizumab will be administered 6 weeks post-tumor resection.

BIOLOGICALSJ-Neo006

SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).

DRUGGemcitabine+Abraxane

Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.


Locations(1)

Wang Sizhen

Nanjing, Jiangsu, China

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NCT06326736


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