Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2022-09-29
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental group
Eligible patients with advanced non-small cell lung cancer with leptomeningeal metastasis were treated with vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed).
pemetrexed
The efficacy of Furmonertinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was evaluated once a week during the treatment phase. After the brain lesions were evaluated as CR, the drug holiday study phase was added. During the study period, the patients were followed up once a week until the investigators deemed the subjects unfit to continue to participate in the study or the efficacy was evaluated as disease progression (PD).
Interventions
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pemetrexed
The efficacy of Furmonertinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was evaluated once a week during the treatment phase. After the brain lesions were evaluated as CR, the drug holiday study phase was added. During the study period, the patients were followed up once a week until the investigators deemed the subjects unfit to continue to participate in the study or the efficacy was evaluated as disease progression (PD).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who meet the requirements of OMMAYA cystlateral ventricle chemotherapy
* Age \> 18 years
* Complete serologic tumor markers (CEA, SCC) and imaging data (enhanced CT and/or MRI, PET-CT)
* Liver, kidney, and hematologic measures were normal (as measured by laboratory testing within 1 week before enrollment in the absence of ongoing supportive care), with a neutrophil count of more than 1.5×109/L, a platelet count of more than 100×109/L, and a hemoglobin level of more than 9.0g/dl ，Bilirubin normal or \<1.5×ULN; AST(SGOT), ALT(SGPT) \<2.5×ULN; Serum creatinine \<1.5×ULN
* The patients were fully aware of the study, provided voluntary written informed consent, and were able to adhere to the protocol-defined visit and follow-up procedures
Exclusion Criteria
* History of allergy to vormetinib and pemetrexed
* Severe complications occurred during the treatment
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* Severe infection in active stage or with poor clinical control
* Mentally ill, substance abusers and pregnant or lactating women
* No informed consent was signed
* Eligibility as judged by the other investigators
18 Years
ALL
No
Sponsors
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Jiangsu Province Nanjing Brain Hospital
OTHER
Responsible Party
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Principal Investigators
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fang S cun, M.D.
Role: STUDY_DIRECTOR
Nanjing Brain Hospital
Locations
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Nanjing Brain Hospital
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MA-ENDO-202209
Identifier Type: -
Identifier Source: org_study_id
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