XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer

Официальное название

Efficacy and Safety Trial of XH001 (Neoantigen Cancer Vaccine) Sequential Combination With Immunocheckpoint Inhibitor and Chemotherapy in Adjuvant Therapy for Patients With Resected Pancreatic Cancer

Обзор

This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with immunocheckpoint inhibitor and chemotherapy in pancreatic cancer patients following surgical resection.

Вмешательства

• Биопрепарат XH001
  XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)
• Препарат Ipilimumab Injection
  Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
• Препарат Sintilimab injection
  Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
• Препарат Chemotherapy
  gemcitabine + capecitabine

Первичные конечные точки

• DFS [Срок оценки: From operation up to 36 months]
• DFS rate [Срок оценки: DFS rate at 12,24, and 36 months after operation]
• MFS [Срок оценки: From operation up to 36 months]
• OS [Срок оценки: From date of operation until the date of first documented date of death from any cause, assessed up to 36 months]

Вторичные конечные точки (4)

• Elispot [Срок оценки: up to 36 months]
• Adverse Event [Срок оценки: up to 36 months]
• ctDNA [Срок оценки: up to 36 months]
• CA19-9 [Срок оценки: up to 36 months]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form;
• Aged 18 to 75 years old;
• Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
• Completed an R0 or R1 surgical resection as determined by pathology；
• Have not received any prior neoadjuvant therapy;
• ECOG score is 0 or 1;
• Life expectancy of greater than 12 months;
• CA19-9 <100U/mL before initial chemotherapy;
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
• Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.

Критерии исключения

• Borderline resectable pancreatic cancer;
• Evidence of disease recurrence or metastasis following surgical resection at any time;
• Evidence of malignant ascites;
• Pre-existing inflammatory bowel disease or the presence of complete or partial bowel obstruction, or persistent severe diarrhea after surgery;
• Needs to receive long-term systemic anti-allergic drug or known hypersensitivity to any component of the study treatment;
• History of autoimmune disease;
• New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening;
• Acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases;
• Received immunomodulatory medications within 4 weeks prior to the date of the first dose (D1) of XH001, including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α;
• Received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days prior to the first dose of XH001;
• Received therapeutic tumor vaccines;
• With congenital or acquired immunodeficiency;
• Participating in other clinical trials and had not withdrawn during screening period;
• Unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator;
• Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06353646 · XKY-C-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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