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Идёт набор NCT06496373

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

Ранняя фаза I С лечением Pancreatic Cancer Resectable Chemotherapy-intolerant

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fixed neoantigen tumor vaccine, personalized neoantigen tumor vaccine, PD-1 inhibitor.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer Resectable, Chemotherapy-intolerant. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Биопрепарат 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.
  • Биопрепарат 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.
  • Препарат PD-1 inhibitor
    Toripalimab

Первичные конечные точки

  • Drug related toxicity [Срок оценки: 18 months]
Вторичные конечные точки (3)
  • Recurrence-free survival (RFS) [Срок оценки: Up to 18 months]
  • overall survival (OS) [Срок оценки: Up to 18 months]
  • Reaction of antigen-specific T cells in peripheral blood [Срок оценки: Up to 18 months]

Критерии участия

Критерии включения

  • Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment
  • Subjects must be >/= 18 years of age at time of informed consent, regardless of gender
  • Patients who have been confirmed by pathology to have pancreatic malignant tumors and have undergone radical surgery for pancreatic malignant tumors for 1-3 months
  • No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by gene sequencing
  • Histologically confirmed pancreatic cancer samples underwent WES and RNA-seq analyses. Bioinformatics prediction identified at least one neoantigen effectively presented by the patient's HLA type, including those derived from KRAS or TP53 mutations.
  • According to the investigator's assessment, the patient is unable to tolerate chemotherapy, such as the score of the Eastern Cooperative Oncology Group (ECOG) Performance Scale ≥ 2 points

Критерии исключения

  • Has had chemotherapy, traditional Chinese medicine with antitumor indications, or other antitumor therapies deemed to conflict with the current treatment by the investigator within 4 weeks prior to the first administration of the study drug
  • History of interstitial lung disease (ILD), pulmonary fibrosis
  • Other serious and/or uncontrollable diseases, which may affect the subject's participation in this study, include but not limited to a) a history of severe drug allergy, or is known to be allergic to any tumor vaccine and PD-1 inhibitor formulation components or has had severe allergic reactions to other monoclonal antibodies in the past, b) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases
  • Researchers believe that there are other reasons that are not suitable for participating in clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06496373 · 2023PCV004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗