An Exploratory Clinical Study of Safety and Efficacy of Neoantigen mRNA Vaccines in the Treatment of Patients With Resectable Pancreatic Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.
详细描述
The first purpose of this study is to evaluate the safety of treating pancreatic cancer with surgery to remove cancerour tissue.
Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.
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
- •Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
- •Subjects must be >/= 18 years of age at time of informed consent.
- •Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection.
- •Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG).
- •Subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for Pancreatic ductal adenocarcinoma（PDAC）.
- •Subjects with estimated survival > 12 weeks.
排除标准
- •Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody or any other immune therapy for pancreatic ductal adenocarcinoma.
- •Known hypersensitivity or allergy to the active substance or to any of the excipients of SJ-neo006, Camrelizumab, Gemcitabine, Abraxane.
- •Actie, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
- •Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
- •Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
- •New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysthythmia, or electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
- •History or autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease.
- •Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.
研究组 & 干预措施
Pancreatic Cancer
Resectable primary pancreatic tumor
干预措施: SJ-Neo006 (Biological)
Pancreatic Cancer
Resectable primary pancreatic tumor
干预措施: Gemcitabine+Abraxane (Drug)
Pancreatic Cancer
Resectable primary pancreatic tumor
干预措施: Surgery (Procedure)
Pancreatic Cancer
Resectable primary pancreatic tumor
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: 2 years
To observe and evaluate the safety of Neoantigen mRNA vaccine combined with Camrelizumab, for the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
次要结局
- Disease control rate (DCR)(3,6,12 months)
研究者
Sizhen Wang
associate chief physician
Jinling Hospital, China