Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2029

Conditions
Pancreatic Cancer Resectable
Interventions
BIOLOGICAL

individualized anti-tumor new antigen iNeo-Vac-R01 injection

The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Neoantigen Therapeutics Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.

DRUG

Gemcitabine + Capecitabine

"Gemcitabine: 1000 mg/m², administered intravenously over 30 minutes on Day 1 and Day 8; Capecitabine: 1650-2000 mg/(m²·day), divided into two daily oral doses from Day 1 to Day 14.~Treatment cycles repeat every 3 weeks for 8 cycles, with the actual number of cycles determined by the investigator based on comprehensive evaluation of the patient's physical status, disease progression, and adverse reactions."

DRUG

Sintilimab injection

Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks

Trial Locations (1)

Unknown

First Affiliated Hospital of Zhejiang University Schlool of Medicine, Hangzhou

All Listed Sponsors
collaborator

Hangzhou Neoantigen Therapeutics Co., Ltd.

INDUSTRY

lead

Zhejiang University

OTHER