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Efficacy and safety of intrathecal pemetrexed for treating leptomeningeal metastasis from lung adenoma cancer: Phase I clinical trial

Efficacy and safety of intrathecal pemetrexed for treating leptomeningeal metastasis from lung adenoma cancer: Phase I clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016615
Enrollment
Unknown
Registered
2018-06-12
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-06-18

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

Conditions

lung cancer

Interventions

Case series:intrathecal pemetrexed

Sponsors

The 2nd Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with meningeal metastasis from lung adenocarcinoma; 2. ECOG PS 0-2; 3. Aged 18 to 75 years; 4. Multiline treatment failures, including systemic chemotherapy or TKI treatment or receiving methotrexate and cytarabine intrathecal chemotherapy; 5. adequate organ function (absolute neutrophil count =1500/mm3, platelet count=100,000/mm3, hemoglobin concentration =9.0g/dL, serum total bilirubin concentration =1.5 mg/dL, serum transaminase concentration =2.5 times the upper normal limit, serum creatinine concentration =1.5 times the upper normal limit, SpO2 =90% on room air, and proteinuria =1+).

Exclusion criteria

Exclusion criteria: 1. HIV-positive patients; 2. history of severe pemetrexed allergies; 3. severe infection or severe comorbidities such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes; 4. Failure to observe test requirements; 5. Pregnancy (verified by serum or urine ß-human chorionic gonadotropin [ß-HCG]) or lactation.

Design outcomes

Primary

MeasureTime frame
Os;

Countries

China

Contacts

Public ContactTao Xin

the 2nd Affliated Hospital of Harbin Medical University

taoxinemail@126.com+86 13633655999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 25, 2026