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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- DFS rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm A
XH001;Ipilimumab Injection;Chemotherapy
干预措施: XH001 (Biological)
Arm A
XH001;Ipilimumab Injection;Chemotherapy
干预措施: Ipilimumab Injection (Drug)
Arm A
XH001;Ipilimumab Injection;Chemotherapy
干预措施: Chemotherapy (Drug)
Arm B
XH001;Sintilimab Injection;Chemotherapy
干预措施: XH001 (Biological)
Arm B
XH001;Sintilimab Injection;Chemotherapy
干预措施: Sintilimab injection (Drug)
Arm B
XH001;Sintilimab Injection;Chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
DFS rate
时间窗: DFS rate at 12,24, and 36 months after operation
disease-free survival rate
MFS
时间窗: From operation up to 36 months
metastasis-free survival (MFS)
OS
时间窗: From date of operation until the date of first documented date of death from any cause, assessed up to 36 months
overall survival (OS)
DFS
时间窗: From operation up to 36 months
disease-free survival (DFS)
次要结局
- Elispot(up to 36 months)
- Adverse Event(up to 36 months)
- ctDNA(up to 36 months)
- CA19-9(up to 36 months)
研究者
Wu Wenming
Prof.
Peking Union Medical College Hospital