NCT05761717尚未招募不适用
Clinical Study of mRNA Personalized Tumor Vaccine Encoding Neonatal Antigen Combined With Sintilimab Injection Liver Cancer
Shanghai Zhongshan Hospital0 个研究点目标入组 67 人开始时间: 2023年4月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 67
- 主要终点
- One-year recurrence-free survival rate (RFS);
研究概览
简要总结
This is an open, one-arm study to evaluate the safety and efficacy of mRNA personalized tumor vaccine (tumor vaccine) encoding neonatal antigen in combination with Sintilimab injection for adjuvant prevention of postoperative recurrence of hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Are ≥18 years old (including boundary values), without limitation of sex at time of consent.
- •The patient was confirmed as hepatocellular carcinoma by histopathology or cytology after surgery, and the lesion was completely resected by surgery R0 (no residual tumor under postoperative microscope and naked eye), and no residual lesion or extrahepatic metastasis was confirmed by postoperative imaging (CT/MRI).
- •The patient is at high risk of postoperative recurrence, and the tumor must meet the following characteristics: Patients with hepatocellular carcinoma IIb/IIIa as defined by the 2019 Chinese Staging System.
- •The Eastern Oncology Consortium Physical State Score (ECOG PS) is 0 or 1, and the Child-Pugh rating is A
排除标准
- •Known allergy to any tumor vaccine, adjuvant, Stintilimab Injection formulation, fluorouracil inj, oxaliplatin injcalcies;
- •Tumor mutation load (TMB) was less than 2.0/Mb or neonatal antigen load (TNB) was less than 0.5/Mb or the predicted number of neonatal antigens was less than 15;
研究组 & 干预措施
3+3
Experimental
Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. This study is a 3+3 dose escalation design.Participants will receive a total of 6 cycles of PCV every 21 days
干预措施: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection (Drug)
结局指标
主要结局
One-year recurrence-free survival rate (RFS);
时间窗: 1 year
Overall survival (OS) after initial administration.
时间窗: 1 year
次要结局
未报告次要终点
研究者
相似试验
Unknown
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