Colorectal cancer
Conditions
Interventions
Experimental group:mFOLFOX 6 (Calcium folinate + 5-fluorouracil + oxaliplatin)+ Zilongjin Tablets
Experimental group:CapeOx (Oxaliplatin + Carboplatin)+ Zilongjin Tablets
Control group:mFOLFOX 6 (Calcium folinate + 5-fluorouracil + oxaliplatin)+Placebo
Control group:CapeOx (Oxaliplatin + Carboplatin)+Placebo
Sponsors
Tianjin People 's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-70 years old, both sexes; 2.ECOG score of 0-2; 3. Patients diagnosed with colorectal cancer according to CSCO Guidelines for the Diagnosis and Treatment of Colorectal Cancer (2024 edition); 4.TNM staging was high-risk stage II and III. According to the Chinese Society of Clinical Oncology (CSCO) Guideline for the diagnosis and treatment of colorectal Cancer in 2024, the high-risk level II is: Stage T4, poorly differentiated histology (high-grade, excluding MSI-H), vascular invasion, perineural invasion, preoperative intestinal obstruction or tumor perforation, positive or indeterminate resection margin, inadequate resection margin distance, or fewer than 12 examined lymph nodes; 5. Patients who have not received postoperative chemotherapy within 6 weeks after radical resection of colorectal cancer and will receive adjuvant chemotherapy with mFOLFOX 6 or CapeOx regimen; 6. Have not participated in other therapeutic clinical trials within 60 days before randomization; 7. No previous or concurrent other primary tumors, except for adequate treatment of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or other tumors cured by surgery and without recurrence for at least 5 years; 8. Organ function meets the following criteria: Blood routine (no blood components and cell growth factor support therapy within 2 weeks before randomization) : absolute neutrophil count =1.5×10^9/L; Platelet count =100×10^9/L; Hemoglobin =90g/L; Liver and kidney function: total bilirubin =1.5×ULN; AST(SGOT), ALT(SGPT)=2.5×ULN; Serum creatinine =1.5×ULN. Heart: The New York Heart Association (NYHA) functional class I in patients with heart failure; After left ventricular ejection fraction (LVEF) =50%. 9. Good compliance, informed consent is required before enrollment.
Exclusion criteria
Exclusion criteria: 1. Those who are known or suspected to be allergic to the known components in the study drug, or those with allergic constitution; 2. Those who have developed intestinal obstruction during the screening period and cannot receive oral medication treatment, and require intravenous high-energy nutrition; 3. Any uncontrolled mental disorders or conditions that may endanger the patient's safety and their compliance with the study, such as severe depression, schizophrenia; 4. Those with severe, uncontrolled organic lesions or infections, and severe bleeding or active bleeding that cannot be controlled, such as patients with decompensated heart, lung, etc. that cannot tolerate chemotherapy; 5. Those who are expected to undergo major surgery (surgery requiring hospitalization) during the study period; 6. Those with autoimmune diseases, immunodeficiency diseases, or a history of organ transplantation; 7. Those who may need to receive treatment with drugs prohibited by the clinical trial protocol during the study period; 8. Those with severe digestive tract diseases that affect the efficacy and safety evaluation of the study: - Those who have had abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months, or active gastrointestinal bleeding. If the lesion causing gastrointestinal bleeding has been removed, it can be excluded; - Those with gastric, duodenal ulcers or ulcer malignancy, intestinal obstruction/irreversible obstruction; - Those with chronic enteritis and/or inflammatory bowel disease of the intestine; - Functional disorders of the colon or small intestine, manifested as more than 3 daily watery stools at baseline; - Chronic diarrhea with a history of extensive small intestine resection; - Those with a history of refractory peptic ulcer disease within 3 months. 9. Those who abuse drugs or are heavy drinkers; 10. Pregnant women, breastfeeding women, those with a possibility of pregnancy, and those planning pregnancy; 11. Those who the investigator considers to have any other conditions that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| EuroQol Five Dimensions Questionnaire;Functional Assessment of Cancer Therapy Colorcctal;Recurrent rate and metastasis rate of colorectal cancer;Chemotherapy completion rate;Tumor markers;Imaging examination;Edmonton Symptom Assessment Scale;Evaluation of Therapeutic Effects Based on Traditional Chinese Medicine Syndrome Classification;Score for the syndrome of spleen deficiency in traditional Chinese medicine;Score for the syndrome of kidney deficiency in traditional Chinese medicine;Score for Cold-Heat Syndrome in Colorectal Cancer; | — |
Countries
China
Contacts
Public ContactChunze Zhang
Tianjin People 's Hospital
Outcome results
None listed