Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Sponsor

Hui Bu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04356118

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Leptomeningeal Metastasis	Drug: Recombinant Human Endostatin Drug: intrathcal methotrexate Drug: Targeted drugs for non-small cell lung cancer	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endostatin Therapy for NSCLC of LM Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted 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 .	Drug: Recombinant Human Endostatin 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. Other Names: Endostatin Drug: intrathcal methotrexate Intrathecal chemotherapy specified dose on specified days. Drug: Targeted 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 .

Arm

Intervention/Treatment

Experimental: Endostatin Therapy for NSCLC of LM

Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted 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 .

Drug: Recombinant Human Endostatin

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.

Other Names:

Endostatin

Drug: intrathcal methotrexate

Intrathecal chemotherapy specified dose on specified days.

Drug: Targeted 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 .

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Objective Response Rate [36 months]
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
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
Overall survival [36 months]
defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age over 18 years old
Pathologically proven non-small cell lung cancer
Karnofsky performance status ≥ 40
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 .
No severe abnormal liver and kidney function;
Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Evidence of bleeding diathesis or serious infection
Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
Pregnant or lactating women