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Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir

NCT06399926 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2024-05-06

No results posted yet for this study

Summary

This is a open-label, multi-center prospective observation study for the efficacy and safety of intraventricle pemetrexed disodium via ommaya reservoir in the treatment of leptomeningeal metastasis with lung cancer who have failed at least one targeted therapy. In detail: At least the treatment failure was after third-generation EGFR-TKIs in EGFR-mutated lung cancer; or at least the treatment failure was after second-generation ALK-TKIs in ALK-mutated lung cancer; or at least the treatment failure was after one-line of targeted-TKIs in ROS1-mutated non-squamous non-small lung cancer.

Conditions

Interventions

DRUG

Pemetrexed injection

Group 1（20mg）:induction stage is 20 mg per 24 hours for 72 hours, every 2 weeks; consolidation stage is 20mg per 24 hours for 72 hours, every 3 weeks.

DRUG

Pemetrexed

Group 2（30mg）:induction stage is 30 mg D1，every week.Consolidation stage is 30 mg D1,every 3 weeks.

Sponsors & Collaborators

  • First People's Hospital of Chenzhou

    collaborator OTHER

  • Xiangtan Central Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • bin Li, doctor · Xiangya Hospital of Central South University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2025-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06399926 on ClinicalTrials.gov