Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relapse Free Survival(RFS)
研究概览
简要总结
This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration.
- •Diagnosed as other malignant tumor;
- •No neoantigen was found in the sequencing data;
- •There have been bone marrow or stem cell transplants;
- •Received systemic glucocorticoids with immunosuppressants;
- •Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
- •With HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
- •Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias;
- •Infected with herpes virus (except those with scabs of more than 4 weeks)；
- •Infected with respiratory virus (except those who have recovered for more than 4 weeks);
- •Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator;
- •Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;
- •Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.
结局指标
主要结局
Relapse Free Survival(RFS)
时间窗: 4 years
Time from surgery to any recurrence
Number of participants experiencing clinical and laboratory adverse events (AEs)
时间窗: 1 years
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
次要结局
- Overall Survival(OS)(4 years)
研究者
Liu Yang
MD
Zhejiang Provincial People's Hospital