About this trial
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).
Eligibility criteria
Qualifiers
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.*
Disqualifiers
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.
Trial design
Treatments tested in this trial
- XLJDOD compound granule
- placebo (XLJDOD mimetic agent)
Treatment groups
Sponsors and collaborators
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