Diabetes drug shows promise in fighting advanced cancers
NCT ID NCT07703163
First seen Jul 14, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This trial investigates whether canagliflozin, a diabetes drug, can be safely combined with the immunotherapy tislelizumab to treat advanced solid tumors. The study includes adults with unresectable, recurrent, or metastatic cancers who have not responded to standard treatments. Researchers will monitor side effects and measure how long patients live without their cancer worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- canagliflozin combined with tislelizumab
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors by combining metabolic and immune therapy.
- What could go wrong
- This is an early-phase trial with only 15 participants, so results may not apply broadly. Side effects from the combination are not yet well understood.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥18 years and ≤80 years old at the time of signing the written informed consent form, regardless of gender. 2. Patients with histologically or cytologically confirmed locally advanced or advanced solid tumors, including: 1. Patients with unresectable locally advanced, recurrent, or distant metastatic solid tumors. 2. Patients who have failed, are intolerant to, or are unsuitable for standard therapy, or for whom no standard therapy is available. 3. Patients considered suitable for treatment with tislelizumab-based immunotherapy by the investigator. 3. 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 lesions with a short diameter ≥10 mm on CT scan, and a scan slice thickness of no more than 5 mm). Lesions that have received local treatments such as radiotherapy can be used as target lesions after clear progression is confirmed. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1, with an expected survival period of ≥3 months. 5. 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 type 2 diabetes mellitus is defined as typical diabetic symptoms plus random blood glucose ≥11.1 mmol/L, or plus fasting blood glucose ≥7.0 mmol/L, or plus 2-hour post-load blood glucose in oral glucose tolerance test (OGTT) ≥11.1 mmol/L, or plus HbA1c ≥6.5%. For those without typical diabetic symptoms, reexamination on another day is required for confirmation (excluding random blood glucose). 6. 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 hematopoietic stimulating factors, and without the use of albumin or blood products): * 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 ≥50 mL/min (Cockcroft-Gault formula). * 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%. 7. 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. 8. Body mass index (BMI) ≥18.5 kg/m² during the study 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 join this study, sign the informed consent form, have good compliance, and patients and their families agree to cooperate with survival follow-up. Exclusion Criteria: 1. Participation in other drug clinical trials within 4 weeks. 2. 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 to enrollment). 3. 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. 4. 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 arrhythmias requiring treatment or intervention. 5. Pregnant or lactating women. 6. Patients with active tuberculosis, bacterial or fungal infections (≥ grade 2, based on NCI-CTCAE 5.0), or HIV infection. 7. Patients with a history of psychoactive drug abuse that cannot be 戒除 (abstained from) or with mental disorders. 8. Subjects with any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has fully remitted and requires no intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators shall not be included). 9. Previous treatment with SGLT2 inhibitors (such as 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, and uncontrolled comorbidities. 12. Female subjects with a pregnancy plan or male subjects whose partners have a pregnancy plan from the screening period to 12 months after medication. 13. Patients with primary peritoneal carcinoma. 14. Patients with type 1 diabetes or diabetic ketoacidosis. 15. History of peripheral vascular disease, neuropathy, or diabetic foot ulcers. 16. Patients with severe renal insufficiency (eGFR \<30 mL/min/1.73 m²). 17. Patients with recurrent genitourinary infections within six months or requiring long-term anti-infective treatment. 18. Patients with a history of lower limb amputation, severe peripheral vascular disease, or neuropathy. 19. Patients with uncontrolled hypothyroidism. 20. Other conditions deemed unsuitable for enrollment by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital
RECRUITINGChengdu, Sichuan, 610041, China
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