Trials Sponsors Conditions Drugs Pricing

Conditions

SGLT 2 Inhibitors Solid Tumor

Keywords

solid tumorSGLT 2 inhibitors

Outcome Measures

Primary Outcomes (1)

Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Treatment-emergent adverse events will be assessed and summarized by number and percentage of participants, severity, seriousness, and relationship to study treatment.
Through study completion, an average of 1 year

Secondary Outcomes (4)

Overall survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression-Free Survival (PFS)
From date of randomization until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 100 months
Immunogenicity assessment
through study completion, an average of 1 year
Gut Microbiome Metagenomic Profiling
From baseline to treatment discontinuation, disease progression, death, or completion of study treatment, whichever occurs first.

Other Outcomes (3)

Percentage of Prescribed Canagliflozin Doses Taken During Study Treatment
From initiation of canagliflozin treatment through treatment discontinuation or completion of study treatment, up to 1 year
Change From Baseline in Blood Glucose Levels During Study Treatment
From baseline until treatment discontinuation, disease progression, death, withdrawal of consent, or completion of study treatment, whichever occurs first.
Change From Baseline in Hemoglobin Levels During Study Treatment
Baseline and during study treatment, up to 1 year

Study Arms (1)

Intervention group

EXPERIMENTAL

Canagliflozin: According to the drug's prescribing information, the recommended starting dose is 100 mg once daily (qd), taken orally before the first meal of the day. For patients who tolerate 100 mg qd and have an estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73 m² with a need for additional glycemic control, the dose may be increased to 300 mg qd. In this study's dose-escalation phase, two dose levels will be evaluated: Low-dose cohort: 100 mg qd, taken before the first meal of the day. High-dose cohort: Starting dose of 100 mg qd for 1 week. If tolerated, the dose will escalate to 300 mg qd, taken before the first meal of the day.

Drug: Canagliflozin

Interventions

CanagliflozinDrug

Low-dose cohort: 100 mg qd, taken before the first meal of the day. High-dose cohort: Starting dose of 100 mg qd for 1 week. If tolerated, the dose will escalate to 300 mg qd, taken before the first meal of the day.

Intervention group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 locally advanced or advanced solid tumors, including:

Sponsors & Collaborators

West China Hospital
Otherlead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Xuelei Ma, MDCONTACT18708305692 drmaxuelei@gmail.com

MeSH Terms

Interventions

Canagliflozin

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Central Study Contacts

Nan Lin, MD

CONTACT

18708305692 linnan@stu.scu.edu.cn

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinical Professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 14, 2026

Study Start

September 10, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

July 31, 2028

You may not qualify 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 tumors that have received radical treatment (at least 5 years prior to enrollment).
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 arrhythmias requiring treatment or intervention.
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.
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).
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 subjects with a pregnancy plan or male subjects whose partners have a pregnancy plan from the screening period to 12 months after medication.
Patients with primary peritoneal carcinoma.
Patients with type 1 diabetes or diabetic ketoacidosis.
History of peripheral vascular disease, neuropathy, or diabetic foot ulcers.
+5 more criteria

Safety and Efficacy of Canagliflozin in Patients With Locally Advanced or Advanced Solid Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (1)

Intervention group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Safety and Efficacy of Canagliflozin in Patients With Locally Advanced or Advanced Solid Cancer

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (1)

Intervention group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations