Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients with Resected Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
研究概览
简要总结
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
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and age ≤75 years.
- •ECOG score 0-
- •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.
排除标准
- •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.
研究组 & 干预措施
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
(1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110)
干预措施: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy (Drug)
结局指标
主要结局
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
时间窗: 3 months after the last administration of neoantigen vaccine
Defined by treatment-related adverse events as assessed by CTCAE v4.0
18-month RFS
时间窗: through study completion, an average of 2 year
defined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first.
次要结局
- 18-month OS(through study completion, an average of 3 year)
研究者
Zhen-Yu Ding
Professor
Sichuan University