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

Leptomeningeal Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04356118
• Other study ID #: BH 005
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2020
• Est. completion date: June 2023

Study information

• Verified date: May 2020
• Source: Hebei Medical University
• Contact: Hui Bu
• Phone: 86-13831106903
• Email: buhuimy1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Leptomeningeal Metastasis
• Lung Neoplasms
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.
• 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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hui Bu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leptomeningeal Metastasis Overall survival	Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up	36 months
Primary	Neurological Progression Free Survival	From the start of treatment until central nervous system metastase progression or death due to any cause	36 months
Primary	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)	36 months
Secondary	Objective Response Rate	ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)	36 months
Secondary	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.	36 months
Secondary	progression-free survival	Proportion of patients progression-free by investigator assessment per RECIST v1.1	36 months
Secondary	Overall survival	defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up	36 months