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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival
From enrollment until disease progression or death
Time frame: 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
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
Survival rate
The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed
Time frame: 3 years
Disease control rate
Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment.
Time frame: 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.
Time frame: 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%.
Time frame: 3 months
The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale
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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.
Time frame: 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.
Time frame: 3 months