This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Intrathecal pemetrexed 50mg,twice per week (d1, d8) for 1 week, then once per 4 weeks
Intrathecal bevacizumab, once (d8)for 1 week, then once per 4 weeks.The initial dose of intrathecal bevacizumab is 5 mg, escalated to 10 mg, and then 25 mg, and then 37.5mg, and then 50mg.
Shanghai Chest Hospital
Shanghai, China
RECRUITINGIncidence of Adverse Events (Safety and Tolerability)
Number of participants with adverse events, treatment emergent adverse events,and serious adverse events assessed by CTCAE v5.0 as a measure of safety and tolerability.
Time frame: From the beginning of the treatment until two months after the treatment.
Overall Survival (OS)
Kaplan-Meier method used to estimate the distribution of OS from the start of study treatment.
Time frame: Up to 2 years
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