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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03716063
Study type Interventional
Source Xiyuan Hospital of China Academy of Chinese Medical Sciences
Contact yu wu, master
Phone 010-62835438
Email 18813084816@163.com
Status Not yet recruiting
Phase Phase 3
Start date October 30, 2018
Completion date December 30, 2021

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