The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
endostatin 7.5mg/㎡/d,Once a day for two weeks, take a week off,start the next cycle, up to four cycles .We advocate a highly individualized treatment plan according to each patients specific manifestations of the disease process.
Intrathecal chemotherapy specified dose on specified days.
EGFR Mutation: Erlotinib,Afatinib,Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
Leptomeningeal Metastasis Overall survival
Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
Time frame: 36 months
Neurological Progression Free Survival
From the start of treatment until central nervous system metastase progression or death due to any cause
Time frame: 36 months
The incidence of adverse reactions
From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
Time frame: 36 months
Objective Response Rate
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
Time frame: 36 months
Neurological assessment
In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome.
Time frame: 36 months
progression-free survival
Proportion of patients progression-free by investigator assessment per RECIST v1.1
Time frame: 36 months
Overall survival
defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up
Time frame: 36 months
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