Durvalumab, Leptomeningeal Metastasis
Conditions
Keywords
Leptomeningeal Metastasis, Durvalumab, Intrathecal chemotherapy
Brief summary
The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis
Interventions
DRUGDurvalumab
Intravenous infusion once every two weeks ,once 10mg/kg.
DRUGmethotrexate
Intrathecal chemotherapy specified dose on specified days
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. Male and Female age 18 or more 2. Pathologically proven non-small cell lung cancer 3. MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid 4. Patients have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. KPS score \<60 2. History of autoimmune diseases 3. With severe hepatic and renal dysfunction 4. Has a history of (non-infectious) pneumonitis that required steroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 36 months | OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive |
| Neurological Progression Free Survival(NPFS) | 36 months | NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause |
| The incidence of adverse reactions | 36 months | In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | 36 months | NPFS was defined as the time between the start of treatment to the date of the first documented tumor progression as determined by investigators per RECIST 1.1,or death due to any cause |
| Objective response rate (ORR) | 36 months | Investigator assessed ORR was defined as the number of subjects whose best objective response (OOR) was a confirmed complete response (CR) or confirmed partial response (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. |
Contacts
Primary ContactHui Bu
Outcome results
None listed