Clinical Trial to Evaluate Safety and Effect of Personalized Neoantigen Vaccine for Pancreatic Tumor Following Surgical Resection and Adjuvant Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and grades of adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction algorithm, in patients with pancreatic ductal adenocarcinoma. The hypothesis of this study is that personalized neoantigen vaccines will be safe and can systemically elicit measurable neoantigen-specific immunologic responses in patients. Participants will receive complete macroscopic resection of primary tumor, standard adjuvant chemotherapy and subsequently personalized neoantigen vaccines.
详细描述
This is a single-center, open-label Phase Ib clinical trial. In this trial, adult subjects with pancreatic ductal adenocarcinoma who have completed resection of the primary tumor and who have not undergone preoperative chemotherapy will be enrolled in the study. Eligible enrolled patients all will undergo tumor resection and all receive adjuvant chemotherapy prior to preparation of the personalized neoantigen vaccine. After the chemotherapy finish, subsequently patients will receive a priming immunization with five doses of the personalized neoantigen vaccine over one month and a boosting immunization with two doses three months later. This clinical trial will examine the safety and effect of the personalized neoantigen vaccine when given at several different time points and will examine the participant's peripheral blood cells for signs that the vaccine induces immunologic responses. Finally we will establish the typical flow to assess efficiency and safety of vaccines according to the different reactivity of patients, as a result, to explore the most suitable practical approaches for applying personalized pancreatic tumor vaccines.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic diagnosis of pancreatic ductal adenocarcinoma
- •Aged ≥20 and ≤75
- •Male or not pregnant women
- •Undergone radical resection (R0 status of resection margins [no cancer cells within 1 mm of all resection margins])
- •No serious underlying disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •No chemotherapy or radiotherapy before resection surgery
- •No significant cardiac, lung, liver, kidney, and bone marrow insufficiency
- •No HIV or syphilis infection
- •Signing informed consent
排除标准
- •Poor postoperative situation
- •Obvious organ dysfunction
- •Radiographically confirmed recurrence or metastasis within 180 days after the surgery
- •Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmias, Myocardial infarction in the past 6 months, and prolonged QT interval (> 450ms)
- •Previous malignant tumors other than pancreatic cancer
- •Cannot be follow up
- •Participating in other clinical trials
- •Without chemotherapy after resection surgery
- •Exit criteria:
- •Missed within one month after surgery or not follow-up as required
- •Patient's own willingness to withdraw
- •Concurrent disease or severe adverse events
- •Protocol violations
- •Administrative reasons
结局指标
主要结局
Incidence and grades of adverse events as assessed by CTCAE v5.0
时间窗: From the first dose of vaccination through 2 years after the surgery
Safety will be assessed by the rate of grade 3 or worse adverse events (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0).
次要结局
- Overall survival(From the date of resection surgery until the date of death from any cause or date of study completion, whichever came first, assessed up to 6 years.)
- Serum CA19-9 or CA72-4 levels(From the date of resection surgery until the date of last documented examination of CA19-9 and CA72-4 or date of study completion, whichever came first, assessed up to 6 years.)
- Recurrence-free survival(From the date of resection surgery until the date of the first confirmed tumor recurrence or date of death from any cause or date of study completion, whichever came first, assessed up to 6 years.)