Phase II Clinical Study for Stereotactic Radiosurgery Combined with Tyrosine Kinase Inhibitors in Treatment of Brain Metastases with EGFR-mutant non–small-cell lung cancer of Patients

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025626

Enrollment

Unknown

Registered

2019-09-03

Start date

2019-09-01

Completion date

Unknown

Last updated

2019-09-09

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

Conditions

lung cancer

Interventions

Experience group:before SRS

control group:after SRS

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged > 18 years old; 2. EGFR positive non-small cell lung cancer patients with brain metastasis confirmed by pathology, gene detection and imaging, and brain metastasis lesions ( 3 months); The main organs were functioning well without severe hypertension, diabetes and heart disease. That is to say, within the first 14 days of randomization, the relevant examination indexes meet the following requirements: (1) blood routine examination: hemoglobin (> 90 g/L) (no blood transfusion within 14 days); neutrophil count > 1.5x10^9/L; platelet count (> 100x10^9/L); (2) biochemical examination: total bilirubin ( 60 ml/min) (Cockcroft-Gault formula); (3) Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) > 50%; (4) blood sugar control in fasting blood sugar < 7.2 mmol/L, non-fasting blood sugar < 10 mmol/L, glycation Hemoglobin < 7%. Sign the informed consent; Good compliance, family members agree to cooperate with survival follow-up.

Exclusion criteria

Exclusion criteria: (1) Participated in clinical trials of other drugs within four weeks, and used TKI treatment; (2) Meningeal metastasis was confirmed; (3) There were many factors influencing oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction); (4) those who had a history of psychotropic drug abuse and could not be cured or had mental disorders; (5) had clinical symptoms; (6) Pleural effusion or peritoneal effusion requiring clinical intervention; (7) history of immunodeficiency, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation; (8) according to the judgement of researchers, there are serious complications that endanger patients'safety or affect patients' completion of the study.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Secondary

Measure	Time frame
ORR;DCR;OS;AEs;	—

Countries

China

Contacts

Public ContactShen Erdong

The People's Hospital of Yueyang

2397637101@qq.com+86 15273077122

Outcome results

None listed

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