XH001 (New Antigen Tumor Vaccine) Combined With Chemotherapy as Adjuvant Therapy in Pancreatic Cancer

Официальное название

Efficacy and Safety of XH001 (New Antigen Tumor Vaccine) Combined With Chemotherapy as Adjuvant Therapy in Pancreatic Cancer Patients

Обзор

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

Вмешательства

• Биопрепарат XH001
  mRNA neoantigen cancer vaccine
• Препарат Chemotherapy
  Gemcitabine+Capecitabine or Oxaliplatin+lrinotecan+Calcium folinate+5-FU

Первичные конечные точки

• DFS [Срок оценки: From operation up to 36 months]
• DFS Rate [Срок оценки: 12,24 and 36 months]
• MFS [Срок оценки: up to 36 months]
• OS [Срок оценки: up to 48 months]

Вторичные конечные точки (2)

• Specific immune response [Срок оценки: up to 36 months]
• Adverse Event [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 pancreatic ductal adenocarcinoma;
• R0 or R1 surgical resection as determined by pathology；
• Have not received any prior neoadjuvant therapy;
• ECOG score is 0 or 1;
• 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 metastasis or disease recurrence 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;
• 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 not enrolled at the 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

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Публикации

• Rojas LA, Sethna Z, Soares KC, Olcese C, Pang N, Patterson E, Lihm J, Ceglia N, Guasp P, Chu A, Yu R, Chandra AK, Waters T, Ruan J, Amisaki M, Zebboudj A, Odgerel Z, Payne G, Derhovanessian E, Muller F, Rhee I, Yadav M, Dobrin A, Sadelain M, Luksza M, Cohen N, Tang L, Basturk O, Gonen M, Katz S, Do RK, Epstein AS, Momtaz P, Park W, Sugarman R, Varghese AM, Won E, Desai A, Wei AC, D'Angelica MI, Ki PMID 37165196

Идентификаторы

NCT: NCT07114666 · I-25PJ0773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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