Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06399926

Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Official title: A Open-label, Random, Multi-central Prospective Cohort of Observation Study on the Efficacy and Safety of Intraventricule Pemetrexed Disodium Via Ommaya Reservoir

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

64

Start Date

2023-10-30

Completion Date

2027-06-30

Last Updated

2024-05-06

Healthy Volunteers

No

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.

Locations (1)

Xiangya Hospital Central South University

Changsha, Hunan, China