Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| China Academy of Chinese Medical Sciences | OTHER |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
|
| Control Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jianpi Huatan dispensing granule | Drug | once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From enrollment until disease progression or death | 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 |
| Overall survival | From enrollment until death or end of the follow-up | From date of randomization until the date of death from any cause, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed | 3 years |
| Disease control rate | Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wu, Master | Contact | 010-62835438 | zoujianhua2021@163.com | |
| Jianhua Zou, Doctor | Contact | 18810209092 | 490943558@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Wu, Master | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo granule | Drug | once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses. |
|
| 3 months |
| Cancer fatigue score | Piper Fatigue Scale will be used.The fatigue of patients will be evaluated from 22 items of behavioral dimension, emotional dimension, sensory dimension and cognitive dimension. The higher the score of each dimension, the more serious the fatigue degree. | 3 months |
| Traditional Chinese Medicine(TCM )symptom grading table | Effective: after treatment, TCM symptom score decreased by more than 50% compared with that before treatment. Effective: decrease < 50% and equal to 30%; Invalid: decrease < 30%. Note: the formula is: (before treatment - integral after treatment) / before treatment by 100%. | 3 months |
| The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale | The raw scores for the scales and single items were linearly transformed to values between 0 and 100 as described in the EORTC QLQ scoring manual. The mean and standard deviation of each scale/single item were calculated. A higher score for a functioning scale represented a healthier level of functioning, a higher score for the global health status scale represented a higher QOL, and a higher score for a symptom scale/item represented a worse level of symptomatology. | 3 months |
| the United States Eastern Oncology Collaboration Group (ECOG) score scale | ECOG scoring standard is an indicator of patients' general health status and tolerance to treatment based on their physical strength. ECOG physical condition rating standard score 0-5 points. A minimum score of 0 indicates normal activity, a higher score indicates less physical activity, and a score of 5 indicates death. | 3 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |