Clinical Study of XP-004 Personlaized mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Drug related toxicity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Neoantigen based vaccines + PD-1 inhibitor
A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.
干预措施: Fixed neoantigen tumor vaccine (Biological)
Neoantigen based vaccines + PD-1 inhibitor
A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.
干预措施: personalized neoantigen tumor vaccine (Biological)
Neoantigen based vaccines + PD-1 inhibitor
A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.
干预措施: PD-1 inhibitor (Drug)
结局指标
主要结局
Drug related toxicity
时间窗: 18 months
Percentage Participants with Adverse Events (AEs) by severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
次要结局
- Reaction of antigen-specific T cells in peripheral blood(Up to 18 months)
- Recurrence-free survival (RFS)(Up to 18 months)
- overall survival (OS)(Up to 18 months)