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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leptomeningeal Metastasis | Experimental | Durvalumab + Intrathecal chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Intravenous infusion once every two weeks ,once 10mg/kg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 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 | 36 months |
| Neurological Progression Free Survival(NPFS) | NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause | 36 months |
| The incidence of adverse reactions | In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | 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 | 36 months |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Bu | Contact | 86-13831106903 | buhuimy1@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Bu | The Second Hospital of Hebei Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D055756 | Meningeal Carcinomatosis |
| ID | Term |
|---|---|
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| methotrexate |
| Drug |
Intrathecal chemotherapy specified dose on specified days |
|
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) |
| 36 months |
| 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 |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |