NCT06074718招募中不适用
Exploring the Therapeutic Effect of Pricking Therapy Combined With Wheat Grain Moxibustion on Malignant Tumors of Spleen Deficiency and Dampness Resistance Type
Jiangsu Taizhou People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (ORR)
研究概览
简要总结
This study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Western medicine and traditional Chinese medicine for malignant tumors;
- •Clinical diagnosis of spleen deficiency dampness obstruction in traditional Chinese medicine;
- •Good compliance and signed informed consent form.
排除标准
- •Patients who cannot lie prone for a long time;
- •Pregnant women;
- •Lactating women
结局指标
主要结局
Progression-Free Survival (ORR)
时间窗: 3 years
Evaluate the objective response rate (ORR) of subjects based on RECIST V1.1
次要结局
- duration of remission (DOR)(5 years)
- progression free survival (PFS),(5 years)
- overall survival (OS)(5 years)
研究者
niqingtao
Deputy Director, Project Management Department, Centre for Clinical Research
Jiangsu Taizhou People's Hospital
研究点 (1)
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