Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir
A Open-label, Random, Multi-central Prospective Cohort of Observation Study on the Efficacy and Safety of Intraventricule Pemetrexed Disodium Via Ommaya Reservoir
Xiangya Hospital of Central South University
64 participants
Oct 30, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
Group 2(30mg):induction stage is 30 mg D1,every week.Consolidation stage is 30 mg D1,every 3 weeks.
Locations(1)
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NCT06399926