Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer

Официальное название

Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer

Обзор

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer

Вмешательства

• Препарат Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
  Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Первичные конечные точки

• 18-month RFS [Срок оценки: through study completion, an average of 2 year]
• Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [Срок оценки: 3 months after the last administration of neoantigen vaccine]

Вторичные конечные точки (1)

• 18-month OS [Срок оценки: through study completion, an average of 3 year]

Критерии участия

Критерии включения

• Age ≥18 years and age ≤75 years.
• ECOG score 0-1.
• Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
• Adequate bone marrow and organ function:
• Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
• Signed informed consent.
• Ability to comply with the study protocol and follow-up.

Критерии исключения

• Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.
• The patient has a history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or urothelial tumors (Ta and TIS), or other malignancies that have been treated with curative intent (at least 5 years prior to enrollment).
• Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias.
• HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.
• Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
• Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, arrhythmias, etc;
• Patients with autoimmune diseases or immunodeficiencies being treated with immunosuppressive drugs.
• Pregnant or lactating women.
• Vaccination with other preventive vaccines within 4 weeks before the first administration or planned during the study period, including within 8 weeks after the last vaccination.
• Those who have had a severe allergic reaction to vaccines for other infectious diseases in the past.
• Those who may be allergic to the investigational product or any of its excipients.
• Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social factors.
• Significant weight loss (≥10%) within 6 weeks prior to enrollment.
• Any uncertain factors that may affect patient safety or compliance.

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

• West China Hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT06344156 · CHANT-231

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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