[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pemetrexed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pemetrexed":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29,30,31,32],"Leptomeningeal Metastasis","Pemetrexed","PD-1 Inhibitor","CTLA4","Solid Tumors",[34,35,36],"Leptomeningeal metastasis","dual checkpoint inhibitor","pemetrexed","RECRUITING","2025-05-14",{"date":40,"type":41},"2025-05-18","ACTUAL",{"date":43,"type":41},"2025-03-17",{"date":45,"type":21},"2026-07-01",{"name":47,"class":48},"Guangzhou Medical University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100574161","phase-2-neoadjuvant-befotertinib-combined-bevacizumab-or-platinum-based-double-chemotherapy-for-resectable-locally-advanced-egfr-mutation-positive-non-small-cell-lung-cancer-100574161","NCT06755684","Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer","Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial","Inclusion Criteria:\n\n* NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;\n* At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or\u002Fand EBUS;\n* No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);\n* With the feasibility to receive radical surgery ;\n* Good lung function that could tolerate surgical treatment;\n* Aged 18-75 years;\n* At least one measurable tumor foci (the longest diameter measured by CT shall be \\> 10 mm);\n* Other major organs shall function well (liver, kidney, blood system, etc.):\n* ECOG PS score shall be 0-1;\n* The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;\n* The patient shall sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;\n* The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \\[≥ Grade II specified by New York Heart Association (NYHA)\\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;\n* The patient is a carrier of HIV;\n* The patient has had or is currently suffering from interstitial lung disease;\n* The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;\n* The patient is allergic to befotertinib or its any excipients;\n* The patient is allergic to bevacizumab or its any excipients;\n* The patient is allergic to platinum-based double chemotherapy or its any excipients;\n* The female patient is in pregnancy or lactation period;\n* There are any conditions under which the investigator considers the patient is not suitable to be enrolled.","18 Years",{"count":58,"type":21},60,[25],"This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation",[62,63,64,29,65,66,67,68],"EGFR","Non-Small Cell Lung Cancer","Locally Advanced Non-Small Cell Lung Cancer","Carboplatin","Bevacizumab","Antineoplastic Agents","Tyrosine Kinase Inhibitor",[70,71,72,66,73],"EGFR-TKI","NSCLC","Chemotherapy","Locally advanced non-small cell lung cancer","2025-01-03",{"date":76,"type":41},"2025-01-06",{"date":78,"type":41},"2024-11-07",{"date":80,"type":21},"2028-12-31",{"name":82,"class":48},"Peng Zhang",1]