NCT06545630招募中1 期
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for R0 Resection of Colorectal Cancer Liver Metastases
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Disease-free Survival
研究概览
简要总结
The aim of this study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of R0 excision Colorectal Cancer Liver Metastases.
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
- •Pathologically confirmed diagnosis of colorectal cancer； Karnofsky performance status 0-1; Patients with tumors identified by pathologic immunohistochemistry as pMMR or by genetic testing as MSS/MSI-L; Imaging diagnosis of stage IV, resection of both primary and metastatic tumors and had NED status after surgery; With a high risk of recurrence, such as liver metastasis CRS score >3 or successful conversion therapy; Multiple peritoneal metastases after CC0; Function of the main organs is normal; Edition Patient's written informed consent
排除标准
- •Tumor emergencies; Abnormal coagulation function; Contagious diseases, such as HIV, HBV, HCV infection; Mental disorders; Concomitant tumors; Immunological co-morbidities
结局指标
主要结局
Disease-free Survival
时间窗: Up to 18 months
Time from assignment to treatment arm until a recurrence or progression of the disease
次要结局
- Overall Survival (OS)(Up to 36 months)
- Adverse Events Related to Treatment(Up to 12 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 month after the last administration of Tumor Antigen-sensitized DC Vaccine)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in TreatingRenal NeoplasmaNCT02487550The First People's Hospital of Changzhou1,200
招募中
1 期
T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With MelanomaMelanomaNCT01946373Karolinska University Hospital20
Unknown
不适用
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid TumorTumor GastricTumor, ColorectalNCT03185429BGI, China20
尚未招募
1 期
Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected IndividualsHIV VaccineNCT05786937University of Sao Paulo General Hospital30
撤回
2 期
A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent GlioblastomaGliomaGlioblastomaNCT02754362NYU Langone Health