Intra-tumor Injection of Drug-eluting Microspheres Loading With Chemodrug Plus Checkpoint Inhibitors and/or IL2 for Treatment of Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors
研究概览
简要总结
To study the safety and clinical effect of injection of drug-eluting microspheres with multiple chemodrug and/or protein drugs into advanced solid tumors.
详细描述
Drug-eluting microspheres such as DC-beads will be loaded with IL2, PD1/PDL1/CTLA4 antibody, or /and VEGF/VEGFR antibody with or without doxorubicin/idarubicin for various time and injected into tumors under CT guidance. Side effects and treatment efficacy after injection of drug-eluting microspheres into malignant tumors will be assessed according to RICEST1.1 standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solid advanced malignant tumors
- •Age between18 and 99 years
- •Life expectancy is greater than three months
排除标准
- •Benign tumor
- •Life expectancy is less than three months
- •Serious medical comorbidity
研究组 & 干预措施
Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies
Intra-tumor injection of above drugs for patients with previous treatment with PDL1 antibody and relapsed.
干预措施: Injection of drug-eluting microspheres with multiple drugs into solid tumors (Drug)
Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies
Intra-tumor injection of above drugs for patients with previous treatment with PD1 antibody and relapsed.
干预措施: Injection of drug-eluting microspheres with multiple drugs into solid tumors (Drug)
Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies
Intra-tumor injection of above drugs for patients with previous heavily treated with PD1/PDL1/CTLA4 antibodies and relapsed.
干预措施: Injection of drug-eluting microspheres with multiple drugs into solid tumors (Drug)
结局指标
主要结局
Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors
时间窗: up to 36 months
Assessing incidence of side effects and primary clinical response of the intra-tumor injection of DEB in advanced solid cancers, including CR, PR, SD, and PD.
次要结局
未报告次要终点