[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578302":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":63,"collaborators":21,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":21,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":21,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":44,"whyStopped":21,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intrathecal Dual Checkpoint Inhibition in Combination with Pemetrexed","EXPERIMENTAL","This study is a prospective, single-arm, Phase I\u002FII clinical trial. The primary objectives were to determine the recommended dose of intrathecal dual checkpoint inhibitor (PD-1 and CTLA-4, QL1706) in combination with pemetrexed and safety based on the incidence of treatment-related adverse events. Clinical response rate (CRR), progression-free survival related to leptomeningeal metastasis (LMPFS) and overall survival (OS) are also evaluated. Patients will have cerebrospinal fluid (CSF) and blood specimen collection for the evaluation of predictors (clinical, molecular, and\u002For immune) of the efficacy and safety of this regimen.",[13,14],"Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4)","Drug: Pemetrexed (Alimta)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","QL1706 (bispecific antibody targeting PD-1 and CLTA-4)","Intrathecal injection of PD-1\u002FCTLA-4 bispecific antibody was administered every 2 weeks for 6 weeks during the induction phase, followed by monthly injections during the maintenance phase, until recurrence or death.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Pemetrexed (Alimta)","Pemetrexed (Alimta, Eli Lilly and Company) was administrated by intrathecal injection, first as induction therapy, twice per week for 2 weeks, followed by consolidation therapy, once per week for 4 weeks, then maintenance therapy, once per month until the patient's death, leptomeningeal metastasis progresses, or intolerable severe adverse events occurred.",[9],[27],{"name":28,"affiliation":29,"role":30},"Zhenyu Pan, PhD,MD","The Affiliated HuizhouHospital, Guangzhou Medical University","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Zhenyu Pan","CONTACT","+8618718178286","dr-zypan@163.com",{"name":38,"role":34,"phone":39,"phoneExt":21,"email":40},"Guozi Yang, PhD,MD","+8615804302755","2023621057@gzhmu.edu.cn",[42,56],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":21},"The Affiliated Huizhou Hospital, Guangzhou Medical University","RECRUITING","Huizhou","Guangdong","516000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.41523,23.11147,{"lat":54,"lon":53},{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},{"type":51,"coordinates":58},[53,54],{"lat":54,"lon":53},[61,62],{"name":28,"role":34,"phone":35,"phoneExt":21,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":21,"email":40},{"type":30,"investigatorFullName":33,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Professor","100578302","phase-1-intrathecal-dual-checkpoint-inhibitor-pd-1-and-ctla-4-in-combination-with-pemetrexed-for-leptomeningeal-metastasis-100578302",false,"NCT06809530","Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis","Intrathecal Administration of Dual Checkpoint Inhibitor in Combination With Pemetrexed in Patients With Leptomeningeal Metastasis: a Phase I\u002FII Study","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.\n2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n3. No history of severe nervous system disease; No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \\>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.\n4. Patients with poor compliance or other reasons that were unsuitable for this study.","ALL","21 Years","75 Years",{"count":76,"type":77},34,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This phase I\u002FII study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.",[84,85,86,87,88],"Leptomeningeal Metastasis","Pemetrexed","PD-1 Inhibitor","CTLA4","Solid Tumors",[90,91,92],"Leptomeningeal metastasis","dual checkpoint inhibitor","pemetrexed","2025-05-14",{"date":95,"type":96},"2025-05-18","ACTUAL",{"date":98,"type":96},"2025-03-17",{"date":100,"type":77},"2026-07-01",{"name":5,"class":6},2]