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Novel mechanisms of acquired resistance to EGFR-TKI in non-small cell lung cancer based on multi-site magnetic sphere enrichment of CTC-high-throughput detection system: a prospective, multicenter clinical study

Novel mechanisms of acquired resistance to EGFR-TKI in non-small cell lung cancer based on multi-site magnetic sphere enrichment of CTC-high-throughput detection system: a prospective, multicenter clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055370
Enrollment
Unknown
Registered
2022-01-08
Start date
2022-01-08
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

non-small cell lung cancer (NSCLC)

Interventions

case series:None

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed inoperable advanced (IIIB or IV) NSCLC patients; 2. Tissue samples confirmed the presence of EGFR sensitive mutations; 3. Receiving first-line EGFR-TKI targeted therapy; 4. Aged >= 18 years; 5. The test results of the patient within 2 weeks before receiving EGFR-TKI treatment meet the following criteria: (1) Neutrophil count > 1,500/mcL Heathco-Pioneer Cancer Research Fund; (2) Platelets > 50,000/mcL; (3) Total bilirubin 1+, the 24-hour total urine protein must be < 500 mg; (7) The coagulation function test results are within the normal range; 6. Understand and voluntarily sign the written informed consent; 7. The investigator judged that the patient had good compliance.

Exclusion criteria

Exclusion criteria: 1. There are uncontrollable concurrent diseases, including but not limited to: symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetes and blood sugar, arrhythmia, mental illness or social conditions, etc.; 2. Patients who are pregnant or breastfeeding; 3. Participate in any other drug research test; 4. HIV-positive patients who are receiving combined antiretroviral combination therapy; 5. The patient has received any malignant tumor surgery (including but not limited to lung cancer); 6. Disease progression within 1 month of treatment or other conditions that consider primary drug resistance; 7. Disease progression judged by discontinuation of drug due to adverse reactions during treatment.

Design outcomes

Primary

MeasureTime frame
Circulating Tumor Cells;Gene Sequencing;

Countries

China

Contacts

Public ContactJiang Liyan

Shanghai Chest Hospital

jiang_liyan2000@126.com+86 13916146759

Outcome results

None listed

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