The design of an adaptive clinical trial to evaluate the effect of metformin on radiation-induced lung injury and survival rate in locally advanced unresectable esophageal carcinoma

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026208

Enrollment

Unknown

Registered

2019-09-26

Start date

2019-10-20

Completion date

Unknown

Last updated

2020-03-23

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

Conditions

esophageal carcinoma

Interventions

exprimental group:Metformin plus Chemo-radiotherapy

control group:Chemo-radiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed esophageal squamous cell carcinoma. 2. Stage II to IVa disease as defined by UICC/AJCC 8th edition staging systerm. 3. Eastern Cooperative Oncology Group (ECOG) performance status of = 1.5 *10^9/L, platelet (>= 100 *10^9/L), hemoglobin (>= 9 g/dL). Liver: bilirubin = 45 mL/min) was calculated (using standard Cockcroft-Gault formula). 9. Life expectancy >= 6 months. 10. Have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Exclusion criteria: 1. Prior radiation therapy,systematic chemotherapy,surgery,target therapy, or immunotherapy for esophageal carcinoma. 2. Distant organ metastasis. 3. Diabetic patient or anyone currently taking Metformin, insulin or other anti-hyperglycemic therapy. 4. Have a history of lactic acidosis or metabolic acidosis. 5. Known hypersensitivity or allergy to Metformin. 6. Have a history of pumonary failure emphysema,Interstitial pneumonia and pumonary fibrosis. 7. Severe pumonary infection or chronic bronchitis. 8. Have signs of esophageal perforation, such as esophageal tracheal fistula and esophageal aortic fistula. 9. Have a history of unstable angina pectoris,Cardiac failure,Cardiac arrhythmia,cerebral infarction. 10. Severe liver disease and renal failure. 11. Poor physical condition can not tolerate radiotherapy and chemotherapy. 12. Known pregnancy or lactating female patient.

Design outcomes

Secondary

Measure	Time frame
Objective Response Rate;Progression free survival ;Overall survival;	—

Primary

Measure	Time frame
Incidence of radiation pneumonia;Pulmonary Function Changes;	—

Countries

China

Contacts

Public ContactWang Wei

Nanfang Hospital of Southern Medical University

29262574@qq.com+86 18520529179

Outcome results

None listed

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