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Safety and efficacy analysis of accumitinib combined with pemetrexed intrathecal injection in the treatment of EGFR mutant lung cancer with meningeal metastasis after first-line TKI treatment failed

Safety and efficacy analysis of accumitinib combined with pemetrexed intrathecal injection in the treatment of EGFR mutant lung cancer with meningeal metastasis after first-line TKI treatment failed

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053724
Enrollment
Unknown
Registered
2021-11-28
Start date
2021-11-18
Completion date
Unknown
Last updated
2022-10-17

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:Amitinib 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 43 histologically confirmed clinical stage IV EGFR-positive lung adenocarcinoma patients with cerebrospinal fluid cytology confirmed meningeal metastasis after first-line TKI therapy; 2. ECOG PS score 0-2 points; 3. Make sure that there is no contraindication to chemotherapy and lumbar puncture; 4. Expected survival time greater than 3 months.

Exclusion criteria

Exclusion criteria: 1. There are contraindications for lumbar puncture; 2. Have a history of allergy to pemetrexed; 3. HIV positive; 4. The existence of autoimmune system diseases; 5. Complicated with serious infection or serious underlying diseases, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, renal failure or poorly controlled diabetes, etc.; 6. Failure to comply with the test requirements; 7. Pregnancy (confirmed by serum or urine beta human chorionic gonadotropin [beta-HCG]) or lactation.

Design outcomes

Primary

MeasureTime frame
Overall survival;Progression-free survival;

Secondary

MeasureTime frame
Objective mitigation rate;

Countries

China

Contacts

Public ContactXin Tao

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