Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer

Study Overview
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Brief Summary
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immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe

Detailed Description
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We will recruit 20 patients with leptomeningeal metastases from lung cancer.

Official Title
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Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer

Conditions
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Leptomeningeal Metastasis, Immune Checkpoint Inhibitor, Endostatin

Intervention / Treatment
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* Drug: Camrelizumab or envafolimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old, gender unlimited; A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis; A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging; Proper organ function (neutrophil count ≥1.5× 109 /L, platelet count ≥100× 109 /L, hemoglobin concentration ≥90g/L, serum transaminase concentration ≤2.5 times the limit of normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normal value, proteinuria ≤1+) Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone Signed the informed consent and was willing to follow the experimental protocol and follow-up Exclusion Criteria: Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes; Be allergic to PD-1 inhibitor and recombinant human endostatin The female patient planned to be pregnant, was pregnant and lactating -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin<br>Camrelizumab 200mg intravenously, once every 21 days or envafolimab 150mg subcutaneous injection,once a week Endostatin 30mg/d was administered intravenously for 7 days (d1-d7). The interval between Endostatin and next was 2 weeks. | Drug: Camrelizumab or envafolimab<br>* combine Camrelizumab or envafolimab with Recombinant human vascular endostatin<br>* Other names: Recombinant human vascular endostatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month overall survival rate | The 3-month survival rate after treatment | 3 month | 
| safty | Adverse events related to treatment | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iPFS | Intracranial progression-free survival | 2 years | 
| extracranial PFS | extracranial progression-free survival | 2 years | 
| DCR | disease control rate | 2 years |