RecruitingEarly Phase 1NCT06496373

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

Clinical Study of XP-004 Personlaized mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer


Sponsor

Ruijin Hospital

Enrollment

20 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a personalized mRNA vaccine — similar in concept to COVID mRNA vaccines but designed to target your specific cancer — combined with a PD-1 immune checkpoint drug, can help prevent pancreatic cancer from coming back after surgery. **You may be eligible if...** - You are 18 or older and have had surgery to remove pancreatic cancer in the past 1–3 months - Your cancer has been confirmed by pathology (tissue testing) - Genetic testing of your tumor found at least one target (neoantigen) for the vaccine - Your doctor feels you cannot tolerate standard chemotherapy (ECOG score ≥ 2) - Your HLA genes (immune system markers) are intact **You may NOT be eligible if...** - You received chemotherapy or other cancer treatments in the 4 weeks before enrolling - You have a history of a serious lung condition like pulmonary fibrosis - You have HIV, immune deficiency, or a history of severe allergic reactions to vaccines or immunotherapy drugs - Your doctor believes you are unsuitable for other reasons 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

BIOLOGICALFixed 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.

BIOLOGICALpersonalized 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.

DRUGPD-1 inhibitor

Toripalimab


Locations(1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06496373


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