Adjuvant Treatment in Cancer Patients with Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disease-free Survival (DFS)
研究概览
简要总结
The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.
详细描述
Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation
- •Anticipated life time > 3month
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Adequate organ functions
排除标准
- •Any evidence of tumor metastasis or co-existing malignant disease
- •Tumor emergency
- •Abnormal coagulation condition
- •Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
- •Concomitant tumors
- •Immunological co-morbidities
研究组 & 干预措施
cell_therapy
tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times
干预措施: DC vaccine subcutaneous administration (Biological)
结局指标
主要结局
Disease-free Survival (DFS)
时间窗: Up to 5 years
Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first
次要结局
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability](3 months after the last administration of cells)
- Overall Survival (OS)(Up to 10 years)
研究者
Zhen-Yu Ding
Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University
Sichuan University