Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
- •TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
- •Expected survival time is over 3 months.
- •The age of 18 years old or more.
- •According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
- •Chemotherapy and/or targeted therapy are planned.
- •Signed informed consent.
排除标准
- •History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
- •Combined with severe heart, liver, lung and kidney disease.
- •Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
- •Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
- •The expected survival time is less than 3 months.
- •The researchers determine that they were not suitable for the study.
研究组 & 干预措施
Experimental Group
The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
干预措施: Jianpi Huatan dispensing granule (Drug)
Control Group
The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
干预措施: Placebo granule (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
From enrollment until disease progression or death
Overall survival
时间窗: From date of randomization until the date of death from any cause, assessed up to 100 months
From enrollment until death or end of the follow-up
次要结局
- Cancer fatigue score(3 months)
- The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale(3 months)
- the United States Eastern Oncology Collaboration Group (ECOG) score scale(3 months)
- Survival rate(3 years)
- Disease control rate(3 months)
- Traditional Chinese Medicine(TCM )symptom grading table(3 months)