NCT04459754招募中2 期
Based on the Real World Prospective Cohort Study, Two-way Analysis of the Dominant Population and Corresponding Phenotypic Characteristics of Patients With Colorectal Cancer Treated by Fuzheng Yiliu Therapy Combined With Adjuvant Chemotherapy
Guangdong Provincial Hospital of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2020年6月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Disease-free Survival
研究概览
简要总结
Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by using real-world data and gene expression profile data.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the patients was 18-75 years old;
- •Radical resection of colorectal cancer (negative margin) was performed;
- •Patients with stage II high risk and stage III colorectal cancer confirmed by histology;
- •No liver, peritoneal or distant metastasis was found;
- •Patients with colorectal cancer who received standard chemotherapy or radiotherapy after operation and had no recurrence or metastasis at the end of radiotherapy and chemotherapy;
- •ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above;
- •Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was less than 1.5 mg / dl;
- •Renal function: creatinine < 1.8mg/dl.
排除标准
- •Allergic to the drug of this scheme;
- •Pregnant or lactating women with fertility requirements during the study period;
- •Severe hypertension, coronary heart disease, diabetes and so on, which are under control for half a year due to cardiovascular accident and poor drug control, are accompanied with other uncontrollable benign diseases such as lung, kidney, liver, infection, etc;
- •Participate in other studies before and during treatment;
- •There was a history of other malignant tumors or multi-source tumors within one year;
- •Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or active phase;
- •Patients with tuberculosis or seizures who need to be treated (e.g. steroids or antiepileptic therapy).
研究组 & 干预措施
Fuzheng Yiliu group
Experimental
干预措施: Fuzheng Yiliu Formulation (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: 3 years
次要结局
未报告次要终点
研究者
Wei Wang
Guangzhou University of Chinese Medicine
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
研究点 (1)
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