[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549259":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":44,"centralContacts":49,"locations":59,"responsibleParty":76,"collaborators":79,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":79,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":79,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":79,"overallStatus":62,"whyStopped":79,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"whole brain LDRT + ICI + intrathecal chemotherapy","EXPERIMENTAL","The treatment regimen consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 30 mg, once per three weeks, 4 cycles in total), PD-1 inhibitor (Sintilimab, via intravenous infusion, once per three weeks, 4 cycles in total)), pemetrexed chemotherapy (via intravenous infusion, once per three weeks, 4 cycles in total) and radiotherapy. Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: 4 Gy\u002F2f of 2 fraction (administered a daily dose of 2 Gy for two days) in group 1; 4 Gy\u002F2f of 4 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 2 cycles in total) in group 2; 4 Gy\u002F2f of 8 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 4 cycles in total) in group 3.",[13,14,15,16],"Radiation: Whole Brain Low Dose Radiotherapy","Drug: Pemetrexed","Drug: Sintilimab","Drug: Chemotherapy",[18,25,32,38],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"RADIATION","Whole Brain Low Dose Radiotherapy","Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: Group 1: 4 Gy\u002F2f of one cycle; Group 2: 4 Gy\u002F2f of two cycles (Q3w); Group 3: 4 Gy\u002F2f of three cycles (Q3w). WB-LDRT will be administered in a 4 Gy of 2 fractions over two days, starting from Day 1 in the first cycle (a daily dose of 2 Gy, 4 Gy\u002F2f for one cycle, once per three weeks, at minmum in one cycle and maximum in four cycles in total).",[9],[24],"WB-LDRT",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Pemetrexed","Pemetrexed, 30 mg, intrathecal injection, once per three weeks, 4 cycles in total",[9],[31],"Intrathecal Chemotherapy",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Sintilimab","PD-1 inhibitor (Sintilimab, dose as recommended in the instruction manual), intravenous infusion, once per three weeks, 4 cycles in total",[9],[37],"PD-1 Inhibitor",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Chemotherapy","Pemetrexed at a dose of 500 mg\u002Fm\\^2, intravenous infusion, once per three weeks, 4 cycles in total",[9],[43],"One of the standard chemotherapy regimens",[45],{"name":46,"affiliation":47,"role":48},"You Lu, MD","West China Hospital","PRINCIPAL_INVESTIGATOR",[50,55],{"name":46,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","18980601763","+86","radyoulu@hotmali.com",{"name":56,"role":51,"phone":57,"phoneExt":53,"email":58},"Lisha Xiang, MD","13320943069","lishaxiang@foxmail.com",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"West China Hospital, Sichuan University","RECRUITING","Chengdu","Sichuan","610041","China","CN",{"type":69,"coordinates":70},"Point",[71,72],104.06667,30.66667,{"lat":72,"lon":71},[75],{"name":56,"role":51,"phone":57,"phoneExt":53,"email":58},{"type":48,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":79,"oldOrganization":79},"You Lu","Chair of Department of Thoracic Cancer",null,"100549259","phase-1-safety-and-efficacy-of-whole-brain-ldrticiintrathecal-chemotherapy-in-refractory-meningeal-metastasis-of-lung-cancer-100549259",false,"NCT06431685","Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer","Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer","Inclusion Criteria:\n\n1. ≥ 18 years old and ≤ 75 years old;\n2. Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.;\n3. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment;\n4. Efficacy of extracranial lesions SD;\n5. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy;\n6. Expected survival ≥3 months, PS score ≤3;\n7. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing;\n8. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases;\n9. One week before enrollment, bone marrow and liver and kidney function met the following criteria:\n\n   ① Hemoglobin ≥80 g\u002FL, neutrophils ≥1.5×10\\^9\u002FL and platelets ≥70×10\\^9\u002FL;\n\n   ② Renal function: Cr≤ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr)≥55 ml\u002Fmin; Liver function: total bilirubin ≤ULN × 1.5; ALT, AST≤ULN × 2.5; (In case of liver metastasis, total bilirubin should not be higher than 3 times the upper normal limit, and transaminase should not be higher than 5 times the upper normal limit);\n10. The fertile women agreed to use contraception during the study period and for 6 months after the study ended; Patients who tested negative for a serum or urine pregnancy test within 7 days prior to joining the study and were not breastfed; Men who agreed to use contraception during the study period and for 6 months after the study ended\n\nExclusion Criteria:\n\n1. Active autoimmune disease or history of autoimmune diseases;\n2. Congenital or acquired immunodeficiency;\n3. Uncontrolled cardiac clinical symptoms or diseases;\n4. Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes;\n5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n6. Other systemic malignancies within the last 5 years;\n7. Allergy to any test drug;\n8. Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator;\n9. Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures.","ALL","18 Years","75 Years",{"count":91,"type":92},10,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.",[98,99,37,100],"NSCLC","Low Dose Radiotherapy","Leptomeningeal Metastasis","2026-05-04",{"date":103,"type":104},"2026-05-08","ACTUAL",{"date":106,"type":104},"2024-04-25",{"date":108,"type":92},"2026-12-31",{"name":5,"class":6},1]