Efficacy and safety of intrathecal pemetrexed combined with dexamethasone for treating leptomeningeal metastasis from lung adenoma cancer: phase II clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050621

Enrollment

Unknown

Registered

2021-09-01

Start date

2021-09-07

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

lung cancer

Interventions

Experimental group:intrathecal pemetrexed combined with dexamethasone

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with meningeal metastasis from lung adenocarcinoma; 2. ECOG PS 0-4; 3. Aged 18 to 75 years; 4. Firstline 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 =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

Measure	Time frame
overall survival;	—

Countries

China

Contacts

Public ContactXin Tao

The Second Affliated Hospital of Harbin Medical University

xintao1234@263.net+86 13633655999

Outcome results

None listed

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