Endostatin, Immune Checkpoint Inhibitor, Leptomeningeal Metastasis
Conditions
Brief summary
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
We will recruit 20 patients with leptomeningeal metastases from lung cancer.
Interventions
DRUGCamrelizumab or envafolimab
combine Camrelizumab or envafolimab with Recombinant human vascular endostatin
Sponsors
Hebei Medical University
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 ≥18 years old, gender unlimited; 2. A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis; 3. A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging; 4. 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+) 5. Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone 6. Signed the informed consent and was willing to follow the experimental protocol and follow-up
Exclusion criteria
1. Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation 2. Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes; 3. Be allergic to PD-1 inhibitor and recombinant human endostatin 4. The female patient planned to be pregnant, was pregnant and lactating -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safty | 2 years | Adverse events related to treatment |
| 3-month overall survival rate | 3 month | The 3-month survival rate after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| iPFS | 2 years | Intracranial progression-free survival |
| extracranial PFS | 2 years | extracranial progression-free survival |
| DCR | 2 years | disease control rate |
Countries
China
Contacts
Primary Contacthui bu, PhD
Backup Contactjiao xue qi, master
Outcome results
None listed