[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554319":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":36,"responsibleParty":50,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":26,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Hunan Province Tumor Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Small Cell Lung Cancer patient with Refractory Brain Metastases",[13],"Drug: Intrathecal Pemetrexed",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Small Cell Lung Cancer patient with Leptomeningeal Metastasis",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Intrathecal Pemetrexed","Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly until progressive disease.",[9,15],[25],"Pemetrexed",null,[28,33],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Yongchang Zhang, MD","CONTACT","+8613873123436","zhangyongchang@csu.edu.cn",{"name":34,"role":30,"phone":35,"phoneExt":26,"email":26},"Liang zeng, MD","15974139200",[37],{"facility":38,"status":26,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":26},"Yongchang Zhang","Changsha","Hunan","410013","China","CN",{"type":45,"coordinates":46},"Point",[47,48],112.97087,28.19874,{"lat":48,"lon":47},{"type":51,"investigatorFullName":38,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Head of Medical Oncology, Director of Early Clinical Trial Center",[54],{"name":55,"class":6},"Second People's Hospital of Hunan","100554319","phase-2-intrathecal-pemetrexed-for-sclc-patients-with-refractory-brain-metastases-or-leptomeninges-metastatic-100554319",false,"NCT06497543","Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metastatic","The Efficacy and Safety of Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeningeal Metastasis: A Phase II Study","Inclusion Criteria:\n\n* 1\\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n* 2\\. Age ≥ 18 years.\n* 3\\. Histopathology is confirmed small cell lung cancer .\n* 4.Leptomeningeal metastasis (LM) is defined by the presence of typical clinical symptoms, positive cerebrospinal fluid (CSF) cytology, detection of cell-free DNA (cfDNA) in CSF by next-generation sequencing (NGS), or imaging findings consistent with typical meningeal metastases.\n* 5.Patients with brain progression after whole-brain radiotherapy.\n* 6\\. Predicted survival ≥ 12 weeks. .\n* 7\\. ECOG 0-2.\n* 8\\. Adequate bone marrow hematopoiesis and organ function.\n\nExclusion Criteria:\n\n* 1\\. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.\n* 2\\. Subjects who have received any of the following treatments must be excluded:\n* Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.\n* 3\\. Presence of spinal cord compression or meningeal metastasis.\n* 4\\. History of other malignant tumors within 2 years.\n* 5\\. Adverse events (except alopecia of any degree) of CTCAE \\> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n* 6\\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n* 7\\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n* 8\\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n* 9\\. Heart-related diseases or abnormalities\n* 10\\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n* 11\\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.\n* 12\\. Live vaccine was given 2 weeks before the first medication.\n* 13\\. Women who are breastfeeding or pregnant.\n* 14\\. Hypersensitivity to the test drug and the ingredients.\n* 15\\. Other conditions assessed by the investigator to be unsuitable for participation in the study.","ALL","18 Years",{"count":66,"type":67},80,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis.",[73],"Small-cell Lung Cancer","NOT_YET_RECRUITING","2024-09-17",{"date":77,"type":78},"2024-09-19","ACTUAL",{"date":80,"type":67},"2024-10-01",{"date":82,"type":67},"2026-04-30",{"name":5,"class":6},1]