[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567063":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":54,"id":58,"slug":25,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Shanghai Chest Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Enrolled patients were treated with pemetrexed intrathecal injection",[13],"Drug: Pemetrexed",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B","Enrolled patients were treated with pemetrexed combined with bevacizumab intrathecal injection",[13,18],"Drug: Bevacizumab",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pemetrexed","Intrathecal pemetrexed 50mg,twice per week (d1, d8) for 1 week, then once per 4 weeks",[9,15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Bevacizumab","Intrathecal bevacizumab, once (d8)for 1 week, then once per 4 weeks.The initial dose of intrathecal bevacizumab is 5 mg, escalated to 10 mg, and then 25 mg, and then 37.5mg, and then 50mg.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Hua Zhong, MD","CONTACT","+86 021-22200000","eddiedong8@hotmail.com",[37],{"facility":5,"status":38,"city":39,"state":25,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Shanghai","200030","China",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},[49],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Hua Zhong","Chief of Respiratory Department",[55],{"name":56,"class":57},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY","100567063",false,"NCT06663306","Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC","Efficacy and Safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases.\n* Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and\u002For MRI diagnosis of leptomeningeal metastasis(LM);\n* Unsatisfactory efficacy of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment;\n* Expected survival time ≥ 1 month;\n* The laboratory test results meet the following criteria:Hemoglobin ≥ 90 g\u002FL, neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN ; Creatinine≤ 2.0 × ULN,or Creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin;\n* Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study;\n* Understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Positive for human immunodeficiency virus (HIV) ;\n* History of allergy to pemetrexed or bevacizumab;\n* History of pemetrexed and\u002For bevacizumab intrathecal Injection;\n* Presence of contraindication of bevacizumab:\n\n  1. Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy;\n  2. Urine protein≥2+,or 24-hour urine protein≥2g；\n  3. Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia;\n  4. Major hemoptysis within the past 1 month; History of coagulation disorders;\n  5. Presence of serious non-healing wounds, ulcers, or bone fractures\n  6. Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction;\n  7. Presence of macrovascular invasion；\n  8. Some neurological disorders unrelated to tumors，such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis;\n* Brain\u002Fspinal cord radiation therapy within 1 week before enrollment;\n* Pregnant and lactating female;\n* Refuse to use contraception during the study period;\n* Individuals considered by the investigator to be unsuitable for enrollment.","ALL","18 Years",{"count":67,"type":68},19,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.",[74,75],"Lung Cancer (NSCLC)","Leptomeningeal Metastasis",[77,78,79],"Leptomeningeal Metastases","NSCLC","Intrathecal Injection","2026-02-26",{"date":82,"type":83},"2026-03-02","ACTUAL",{"date":85,"type":83},"2024-12-09",{"date":87,"type":68},"2027-12-30",{"name":5,"class":6},1]