Leptomeningeal Metastasis
Conditions
Keywords
Recombinant Human Endostatin, Non-Small Cell Lung Cancer with Leptomeningeal Metastasis
Brief summary
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
Interventions
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.
DRUGintrathcal methotrexate
Intrathecal chemotherapy specified dose on specified days.
DRUGTargeted drugs for non-small cell lung cancer
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 .
Sponsors
Hui Bu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years old 2. Pathologically proven non-small cell lung cancer 3. Karnofsky performance status ≥ 40 4. LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI . 5. No severe abnormal liver and kidney function; 6. Patients have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. Evidence of bleeding diathesis or serious infection 2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) 3. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leptomeningeal Metastasis Overall survival | 36 months | Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up |
| Neurological Progression Free Survival | 36 months | From the start of treatment until central nervous system metastase progression or death due to any cause |
| The incidence of adverse reactions | 36 months | From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 36 months | ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR) |
| Overall survival | 36 months | defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up |
| Neurological assessment | 36 months | 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. |
| progression-free survival | 36 months | Proportion of patients progression-free by investigator assessment per RECIST v1.1 |
Contacts
Primary ContactHui Bu
Outcome results
None listed