Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

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.

once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Jianpi Huatan dispensing granule

Placebo granule

Yu Wu, Master

Jianhua Zou, Doctor

Cui Ning, master

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.

Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer

Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics

From enrollment until disease progression or death

From enrollment until death or end of the follow-up

The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed

Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment.

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.

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%.

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.

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.

China Academy of Chinese Medical Sciences

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Xiyuan Hospital of China Academy of Chinese Medical Sciences

The test group will oral Jianpi Huatan dispensing granule , once a day in the morning and evening, once a month for a course of treatment, a total of three courses.

The control group will oral drug:low-dose control granules (containing 1/10 of the dose of the experimental group) , once a day in the morning and evening, once a month for a course of treatment, a total of three courses

once a day in the morning and evening, every month for a course of treatment, a total of three courses

yu wu, master

liusheng li, doctor

ning cui, master

yufei yang, doctor

This study will take disease-free survival time and recurrence and metastasis rate as the main evaluation indexes, to evaluate the clinical efficacy of strengthening the spleen and reducing phlegm method in patients with stage II high-risk and stage III colorectal cancer

The study enrolled 350 patients with stage II high-risk and stage III colorectal cancer who underwent adjuvant chemotherapy (based on a 5-fluorouracil（5-FU） regimen for at least 3 months) and patients who received chemotherapy for less than 3 months. The study will use a large sample, multicenter, randomized, double-blind study. The experimental group was given oral Jianpi Huatan dispensing granule, once a day in the morning and evening, 1 course per 1 month, a total of 3 courses; the control group of oral Chinese medicine formula low dose control granules (including the test group dose 1 /10), 1 time each morning and evening, 1 course per month, for a total of 3 courses.

The patients were followed up once a month during the treatment period and once every 3-6 months after the end of treatment until the patient relapsed, died or the study was over.Some patients in the study will be tested for circulating tumor cells.

Main outcome measures is Disease-free survival time（DFS）and Metastasis recurrence rate in 1 year；Secondary outcome measures：Quality of life score: applied quality of life scale.Metastasis recurrence rate in 2、3years.

This study was double-blind. According to the randomized results, the experimental group was given orally therapeutic granules, while the control group was given orally low-dose granules.

This study was double-blind. According to the randomized results, the experimental group was given orally therapeutic granules, while the control group was given orally low-dose granules. Random sequence was generated by professional statisticians of group leader unit by statistical software. 350 subjects were divided into experimental group and control group according to the ratio of 1:1, 175 cases in each group. Random seeds and random sequences are stored as confidential data in opaque envelopes, and emergency envelopes are handed over to a third party to ensure that patients, researchers and outcome evaluators are unaware of the patient group before blindness is uncovered. After successful screening and signing the informed consent form, the patient can open a random envelope in turn and record the subject's name, hospital number and admission time on the envelope.

Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer

Evaluation and Mechanism of Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer

from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.

The ratio of metastasis and recurrence to the patients was observed.

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%

The FACT-C scale was divided into five grades: none (0), one point (1), some (2), equivalent (3) and very (4). The positive items (i.e. the higher the grade, the better the quality of life.)

The scale used digital scoring method, each symptom scoring range of 0-10 points, 0 points for asymptomatic, 10 points for the most serious degree imaginable, patients choose a number to express their subjective feelings, the larger the number indicates the more serious the symptoms. 1\~10 points were divided into 3 degrees, mild, moderate and severe. 1\~3 were mild, 4\~6 were moderate, and 7\~10 were severe

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer	NCT05187481	Colorectal Neop...	Jianpi Huatan d... Placebo granule	18 Years -	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer	NCT03716063	Colorectal Canc...	Jianpi Huatan d...	18 Years - 80 Years	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer	NCT05187481	Colorectal Neop...	Jianpi Huatan d... Placebo granule	18 Years -	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer	NCT05187481	Colorectal Neop...	Jianpi Huatan d... Placebo granule	18 Years -	Xiyuan Hospital of China Academy of Chinese Medical Sciences

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