Trials Sponsors Conditions Drugs Pricing

Conditions

Colorectal Cancer SGLT-2 Inhibitor

Keywords

colorectal cancerSGLT-2 inhibitor

Outcome Measures

Primary Outcomes (1)

Adverse Effect
Adverse Effect
through study completion, an average of 1 year

Secondary Outcomes (2)

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 progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (1)

Intervention group

EXPERIMENTAL

PD-1 Inhibitor: Tislelizumab will be administered intravenously at the recommended dose of 200 mg every 3 weeks until disease progression or intolerable toxicity occurs. 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.

Also known as: ICIs

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 colorectal cancer, including:

Sponsors & Collaborators

West China Hospital
Otherlead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Nan LinCONTACT+86 18708305692 sculinnan@qq.com

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Thiophenes

Central Study Contacts

Nan Lin, MD

CONTACT

+86 18708305692 sculinnan@qq.com

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: Deputy Director (Medical) of the Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University; Associate Director of the Stem Cell Research and Translational Research Laboratory; PhD Supervisor; Professor/Researcher

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 22, 2025

Study Start

July 31, 2025

Estimated (date passed)

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

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.
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.
+5 more criteria

Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal 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 (2)

Study Arms (1)

Intervention group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

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 (2)

Study Arms (1)

Intervention group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations