Colorectal cancer
Conditions
Interventions
Intervention group:According to the canagliflozin drug label, the recommended starting dose is 100 mg once daily, taken before the first meal of the day. For patients who tolerate 100 mg once daily, h
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be eligible for inclusion: 1.Aged >=18 years and =10 mm on CT scan; lymph node lesion: short diameter >=10 mm on CT scan, with a scan slice thickness of =3 months. 5.Patients with Type 2 Diabetes Mellitus (T2DM) who meet the indications for canagliflozin; or patients without a diabetes diagnosis, no history of Type 1 diabetes or diabetic ketoacidosis. Diagnosis of T2DM: Typical diabetic symptoms plus random plasma glucose >=11.1 mmol/L, or fasting plasma glucose >=7.0 mmol/L, or 2-hour plasma glucose in oral glucose tolerance test (OGTT) >=11.1 mmol/L, or HbA1c >=6.5%. For those without typical diabetic symptoms, rechecking on another day is required for confirmation (excluding random plasma glucose). 6.Good major organ function, with relevant test indicators within the following ranges within 14 days before randomization (without blood or blood product transfusion, hematopoietic stimulating factors, albumin, or blood products): (1) Hematology: Hemoglobin >=80 g/L; neutrophil count >1.5×10?/L; platelet count >=90×10?/L. (2) Biochemistry: Total bilirubin =50 mL/min (Cockcroft-Gault formula). (3) Coagulation: Prothrombin time (PT), international normalized ratio (INR) =50%. (5) Renal function: Estimated glomerular filtration rate (eGFR) >=60 mL/min/1.73 m². (6) Blood glucose: HbA1c =18.5 kg/m² during the screening period. 9.If complicated with hypertension, blood pressure must be controlled to a stable level with other medications. 10.No history of peripheral vascular disease, neuropathy, or diabetic foot ulcers. 11.Patients voluntarily agree to participate in the study, sign the informed consent form, demonstrate good compliance, and the patient and family agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Participation in other drug clinical trials within 4 weeks. 2. History of other malignancies, except for: In situ cervical cancer, treated cutaneous squamous cell carcinoma, bladder epithelial tumors, or other malignant tumors that have received radical treatment (at least 5 years prior to enrollment). 3. Symptomatic or rapidly progressing central nervous system metastases; patients with extensive lung metastases causing dyspnea; patients with tumors approaching or invading major blood vessels or nerves. 4. Uncontrolled cardiac clinical symptoms or diseases, such as: New York Heart Association (NYHA) class >=II heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular/ventricular arrhythmias requiring treatment or intervention. 5. Pregnant or lactating women. 6. Active tuberculosis, bacterial/fungal infection (>=grade 2, based on NCI-CTCAE 5.0), or HIV infection. 7. History of substance abuse (psychotropic drugs) with inability to quit, or mental disorders. 8. Active autoimmune diseases or history of autoimmune diseases (including but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions: Vitiligo or childhood asthma completely resolved without adult intervention is allowed; asthma requiring bronchodilator intervention is excluded. 9. Previous treatment with SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin, canagliflozin). 10. Long-term steroid use or combined use of insulin/insulin sensitizers. 11. Baseline HbA1c >10%; history of stroke or transient ischemic attack within 5 years with uncontrolled comorbidities. 12. Female subjects planning to become pregnant, or male subjects whose partners plan to become pregnant, from screening to 12 months after medication. 13. Known BRAF V600E-mutated CRC patients or peritoneal cancer patients. 14. Type 1 diabetes or diabetic ketoacidosis. 15. History of peripheral vascular disease, neuropathy, or diabetic foot ulcers. 16. Severe renal insufficiency (eGFR <30 mL/min/1.73 m²). 17. Recurrent genitourinary infections within 6 months or patients requiring long-term anti-infective therapy. 18. History of lower limb amputation, severe peripheral vascular disease, or neuropathy. 19. Uncontrolled hypothyroidism. 20. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response reate (ORR) (RECIST v1.1);Overall survival ;Adverse events; | — |
Countries
China
Contacts
Public ContactXuelei Ma
West China Hospital of Sichuan University
Outcome results
None listed