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Clinical study on the effect of metformin on tumor immune microenvironment of oral squamous cell carcinoma

Clinical study on the effect of metformin on tumor immune microenvironment of oral squamous cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070257
Enrollment
Unknown
Registered
2023-04-06
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Squamous carcinoma

Interventions

Experimental group:Metformin after preoperative diagnosis of oral squamous carcinoma
control group:no intervention

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a clinical diagnosis of primary oral squamous cell carcinoma; 2. Patients for whom radical surgery is the preferred treatment option; 3. Aged 18-80 years; 4. Normal liver and kidney function; 5. Able to understand and complete a written informed consent form to sign; 6. Accept treatment and follow up.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes mellitus. (Patients with a history of gestational diabetes only will be allowed to be included in the study); 2. Patients with metformin allergy; 3. Patients with immune system disorders. (e.g. systemic lupus erythematosus, rheumatic heart disease, rheumatoid arthritis, scleroderma, primary platelet purple epilepsy, AIDS, etc.); 4. Patients with diseases that can cause tissue hypoxia (especially worsening of acute or chronic diseases), such as decompensated heart failure, respiratory failure, recent episodes of myocardial infarction, shock, etc.; 5. History of metformin administration in the last 6 months; 6. History of metabolic acidosis, including increased risk of ketoacidosis or lactic acidosis; 7. Pregnancy or lactation; 8. Patients with any other serious systemic disease; 9. Patients with a previous history of renal disease; 10. Patients with uncorrected vitamin B12 or folic acid deficiency; 11. Patients with other known active malignancies (excluding adequately treated basal cell/squamous cell skin cancer, carcinoma in situ or other cancers for which the patient has been disease-free for 2 years); 12. Patients receiving other experimental drug therapy. Unwilling to participate in this program without informed consent. Those who are unable to adhere to long-term medication and have difficulty following up with poor adherence.

Design outcomes

Primary

MeasureTime frame
blood Immune cell;organization Immune cell;

Secondary

MeasureTime frame
Blood routine;Liver and kidney function;lactic acid;Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactTong Su

Xiangya Hospital, Central South University

sutongs@163.com+86 138 0848 2877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026