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Analysis of safety and efficacy of ametinib combined with pemetrexed intrathecal injection in the treatment of meningeal metastases of EGFR mutant lung cancer after failure of first-line TKI treatment

Analysis of safety and efficacy of ametinib combined with pemetrexed intrathecal injection in the treatment of meningeal metastases of EGFR mutant lung cancer after failure of first-line TKI treatment

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041527
Enrollment
Unknown
Registered
2020-12-27
Start date
2020-12-27
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Lung cancer meningeal metastases

Interventions

experimental group:ametinil combined with pemetrexed intrathecal injection

Sponsors

The Second Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The study population consisted of 20-25 patients with histologically confirmed clinical stage IV EGFR positive lung adenocarcinoma; 2. Patients with meningeal metastasis confirmed by CSF cytology after first-line TKI treatment; 3. Patients with ECoG PS score 0-2; 4. Determine the patients without contraindications of chemotherapy and lumbar puncture; 5. Patients whose expected survival time is more than 3 months; 6. Collect the clinical data needed for the study.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications of lumbar puncture; 2. Patients with allergic history of pemetrexed; 3. HIV positive subjects; 4. Patients with autoimmune diseases; 5. Patients with severe infection or severe underlying diseases, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, renal failure or poorly controlled diabetes, etc.; 6. Patients who can not comply with the test requirements; 7. Pregnant (confirmed by serum or urine ß - hCG) or lactating subjects.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Progression-free survival;Objective mitigation rate;

Countries

China

Contacts

Public ContactTao Xin

The Second Affiliated Hospital of Harbin Medical University

xintao123456x@163.com+86 13633655999

Outcome results

None listed

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