This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
Colon carcinoma confirmed by pathology.*
Completion of surgical resection of tumors with negative margins (R0 resection) and at least 3 months of adjuvant chemotherapy based on 5-fluorouracil (5-FU). *
Within 3 months after the completion of adjuvant chemotherapy.
Patients with Stage IIIB or IIIC disease.*
Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.
Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.
Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.
Parallel
XLJDOD compound granule
DrugTreatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses.
placebo (XLJDOD mimetic agent)
DrugThe course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
Two-year disease-free survival (DFS)
2-year DFS is defined as the percentage of patients alive without disease recurrence at 2 years measured from the randomization date.
Three-year disease-free survival (DFS)
3-year DFS is defined as the percentage of patients alive without disease recurrence at 3 years measured from the randomization date.
One, two, three-year relapse rate (RR)
RR is defined as the fraction of followed patients who have disease recurrence. All disease recurrences and deaths from colon cancer are events. Second primary same cancers and other primary cancers will be ignored.
Three-year survival rate
3-year survival rate is defined as the percentage of patients alive at 3 years measured from the randomization date.
Overall survival (OS)
OS is measured from the date of enrollment to the date of death, irrespective of cause.
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Jiangsu Famous Medical Technology Co., Ltd.
Lead sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Ministry of Science and Technology of the People´s Republic of China
Collaborator
