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Tests treatment safety and results for Colorectal Cancer
Official title Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer
ClinicalTrials.gov ID: NCT07076823
What this study is testing
What is Canagliflozin?
Canagliflozin is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Also referred to as ICIs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colorectal cancer (CRC), ranking third in incidence among men and second in women globally with third-highest mortality in the US, remains a major health challenge despite multimodal therapies, particularly for advanced-stage patients with poor prognosis where immune checkpoint inhibitors (ICIs) like PD-1/PD-L1 blockers have emerged as transformative agents by reinvigorating anti-tumor immunity through PD-1/PD-L1 pathway inhibition. While MSI-H CRC's high mutational burden renders it susceptible to immunotherapy, clinical trials demonstrate durable responses with domestic ICIs such as tislelizumab showing 41.2% ORR, 14.4-month PFS, and 28.7-month OS in metastatic MSI-H CRC, yet unmet needs persist.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Aged ≥18 years and ≤80 years old at the time of signing the written informed consent form, regardless of gender.
- Patients with histologically or cytologically confirmed colorectal cancer, including:
- Patients with unresectable locally advanced, recurrent, or distant metastatic colorectal cancer.
- Patients with wild-type RAS/RAF and BRAF V600E genotypes in tumor tissues.
- Patients with microsatellite instability-high (MSI-H) colorectal cancer confirmed by MSI testing.
You likely can't join if
- Participation in other drug clinical trials within 4 weeks.
- History of other tumors, except for in-situ cervical cancer, treated cutaneous squamous cell carcinoma, bladder epithelial tumors, or other malignant...
- Patients with symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, or tumors approaching...
- Uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class 2 or above, unstable angina, myocardial infarction within 1...
- Pregnant or lactating women.
- Patients with active tuberculosis, bacterial or fungal infections (≥ grade 2, based on NCI-CTCAE 5.0), or HIV infection.
See the full eligibility criteria
Who can join
- Aged ≥18 years and ≤80 years old at the time of signing the written informed consent form, regardless of gender.
- Patients with histologically or cytologically confirmed colorectal cancer, including:
- Patients with unresectable locally advanced, recurrent, or distant metastatic colorectal cancer.
- Patients with wild-type RAS/RAF and BRAF V600E genotypes in tumor tissues.
- Patients with microsatellite instability-high (MSI-H) colorectal cancer confirmed by MSI testing.
- Patients who have experienced disease progression after receiving at least two lines of standard treatment, or who cannot tolerate the toxic side effects.
- According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), patients must have at least one target lesion with measurable diameters (tumor lesions with a long diameter ≥10 mm on CT scan, lymph node...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1, with an expected survival period of ≥3 months.
- Patients must be type 2 diabetes mellitus (T2DM) patients and meet the indications for canagliflozin; or patients have no diagnosis of diabetes, no history of type 1 diabetes or diabetic ketoacidosis. The diagnosis of...
- Good function of major organs, that is, the relevant examination indicators within 14 days before randomization meet the following requirements (without blood or blood product transfusion, without the use of...
- Routine blood test: Hemoglobin ≥80 g/L; neutrophil count \>1.5×10⁹/L; platelet count ≥90×10⁹/L.
- Biochemical test: Total bilirubin ≤1.5×ULN (upper limit of normal value); serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; serum creatinine (SCr) ≤1.5×ULN or creatinine clearance rate...
- Prothrombin time (PT), international normalized ratio (INR) ≤1.5×ULN (unless warfarin anticoagulation is being used).
- Cardiac Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥50%.
- Renal function: eGFR ≥60 mL/min/1.73 m².
- Blood glucose: HbA1c ≤9%.
- Patients of childbearing potential (both male and female) must use effective medical contraceptive measures during the study period and within 6 months after the end of drug administration.
- Body mass index (BMI) ≥18.5 kg/m² during the study screening period.
- If complicated with hypertension, blood pressure must be controlled to a stable level with other medications.
- No history of peripheral vascular disease, neuropathy, or diabetic foot ulcers.
- Patients voluntarily join this study, sign the informed consent form, have good compliance, and patients and their families agree to cooperate with survival follow-up.
What rules you out
- Participation in other drug clinical trials within 4 weeks.
- History of other tumors, 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...
- Patients with symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, or tumors approaching or invading major blood vessels or nerves.
- Uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class 2 or above, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular...
- Pregnant or lactating women.
- Patients with active tuberculosis, bacterial or fungal infections (≥ grade 2, based on NCI-CTCAE 5.0), or HIV infection.
- Patients with a history of psychoactive drug abuse that cannot be 戒除 (abstained from) or with mental disorders.
- people with any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; people with vitiligo or...
- Previous treatment with SGLT2 inhibitors (such as dapagliflozin, empagliflozin, canagliflozin).
- Long-term steroid use or combined use of insulin/insulin sensitizers.
- Baseline HbA1c \>10%, history of stroke or transient ischemic attack within 5 years, and uncontrolled comorbidities.
- Female people with a pregnancy plan or male people whose partners have a pregnancy plan from the screening period to 12 months after medication.
- CRC patients with known BRAF V600E mutation or peritoneal cancer patients.
- Patients with type 1 diabetes or diabetic ketoacidosis.
- History of peripheral vascular disease, neuropathy, or diabetic foot ulcers.
- Patients with severe renal insufficiency (eGFR \<30 mL/min/1.73 m²).
- Patients with recurrent genitourinary infections within six months or requiring long-term anti-infective treatment.
- Patients with a history of lower limb amputation, severe peripheral vascular disease, or neuropathy.
- Patients with uncontrolled hypothyroidism.
- Other conditions deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.