[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-metastasases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-metastasases":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,61,86,116,141,162,185,210,224,246,270,291,310],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100053384","phase-3-bevacizumab-versus-corticosteroids-as-first-line-treatment-in-patients-with-symptomatic-cerebral-radiation-necrosis-after-radiation-for-high-grade-glioma-or-brain-metastases-100053384",false,"NCT06888817","Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases","Bevacizumab for the Treatment of Cerebral RAdiation Induced NecrosiS (BRAINS) Study: a Multicenter, Open-label, Randomized Clinical Trial to Assess the Clinical Efficacy and Cost-effectiveness of Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases","BRAINS","Inclusion Criteria:\n\nInclusion all patients (both HGG and BM):\n\n1. Age ≥ 18 years old\n2. First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A clear working diagnosis of CRN without evidence of a combination with tumour progression is required\n3. KPS score ≤ 90 and either (a) a minimum loss of two points in at least one domain of the Neurologic Assessment in Neuro-Oncology (NANO) scale as compared to the maximum score of that domain due to sCRN, or (b) a headache attributable to sCRN with an average intensity ≥5\u002F10 on the NRS, persisting for ≥10 consecutive days, with inadequate relief despite an adequate trial of paracetamol and\u002For an NSAID unless these medications are contra-indicated or not tolerated\n4. Maximum daily dexamethasone use of 1 mg\u002Fday for the 8 weeks preceding randomization\n\n   1. Dexamethasone may have been prescribed for various indications, except for managing (ongoing) cerebral edema\n   2. Higher doses of dexamethasone are permitted 3 weeks immediately preceding randomization if used specifically for the treatment of sCRN\n5. Able to understand the patient information, online tests and questionnaires\n6. Written informed consent\n\nInclusion BM:\n\n1\\. BM of solid tumour, including all primary tumour types\n\nInclusion HGG:\n\n1\\. A confirmed histological diagnosis of high-grade diffuse glioma according to WHO 2021 criteria, including: astrocytoma, IDH-mutant, grade 3-4; astrocytoma, IDH-wildtype (sybtype molecular glioblastoma); oligodendroglioma, 1p\u002F19q codeleted, grade 3; diffuse glioma, NEC, grade 3-4; or glioblastoma, IDH-wildtype, grade 4\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study, both for the BM and HGG group:\n\n1. Prior treatment with bevacizumab \\\u003C6 months before diagnosis of sCRN\n2. Life expectancy \\\u003C3 months\n3. Impending radiological or clinical signs of brain herniation necessitating immediate decompressive surgery\n4. Any comorbidity or condition that prevents safe administration of the studied medication, determined by the treating physician, including but not limited to:\n\n   1. Intolerance for murine proteins\n   2. Hypersensitivity or allergy to the active substance or to any of the excipients of bevacizumab or dexamethasone\n   3. Nephrotic syndrome or abnormal renal function\n\n      o Calculated (Cockcroft-Gault) or measured creatinine clearance \\\u003C30 mL\u002Fmin; urine dipstick for proteinuria ≥ 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein\u002F24 hr.\n   4. Clinical significant cardiovascular disease\n\n      * Uncontrolled hypertension (systolic BP \\>150mmHg and\u002For diastolic \\>100mmHg) despite the use of ≥ 3 antihypertensive drugs\n      * Previous hypertensive crisis, hypertensive encephalopathy or previous reversible posterior leukoencephalopathy syndrome (RPLS)\n      * Non tumour related vascular event (e.g. cerebral or cardiac ischemia\u002Fbleeding (including transient ischemic attack, cerebral ischemia, unstable angina or angina requiring intervention, myocardial infarction), peripheral arterial thrombus, peripheral artery disease, deep venous thrombosis, lung embolism) \\\u003C 6 months\n      * History of aortic aneurysm or dissection\n      * Congestive heart failure NYHA II-IV\n   5. History of gastro-intestinal fistula, perforation or abscess \\\u003C 6 months\n   6. History of bleeding\n\n      * Relevant pulmonary hemorrhage\u002F hemoptysis \\\u003C 1 month or the presence of a pulmonary lesion with a high risk of bleeding (= central lung tumour and\u002For untreated squamous cell carcinoma) according to the treating physician\n      * Active gastrointestinal bleeding \\\u003C 6 months\n      * Evidence of recent intracranial hemorrhage on MRI brain \\\u003C3 months. Asymptomatic presence of hemosiderin depositions or punctate hemorrhage in the tumour do not serve as a ground for exclusion\n   7. Excess risk of bleeding\n\n      * History or evidence of inherited bleeding diathesis or significant coagulopathy with the risk of bleeding\n      * Decreased platelet count \\\u003C 75x109\u002FL\n   8. Risk of wound healing complications\n\n      * Significant non-healing wound, (peptic) ulcer or bone fracture\n      * Major surgical procedure (including open biopsy) or significant traumatic injury within 28 days prior to first study treatment or planned surgical procedure within the following next 28 days after planned study inclusion\n      * Minor surgical procedure, stereotactic\u002Fcore biopsy, fine needle aspiration within 7 days prior to first study treatment\n   9. High-dose radiotherapy to the mediastinum, abdomen, or lower pelvis; administration of bevacizumab should only be considered after prior consultation with a pulmonologist or oncologist\n   10. Pregnancy or lactation. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to randomization. WOCBP and female partners of male patients must comply with adequate contraception methods as requested by the study protocol\n   11. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the study treatment, affect patient compliance or place the patient at high risk for treatment-related complications according to the treating physician\n   12. Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another interventional study In case of uncertainty, consult the principal investigator of the study site.","ALL","18 Years",{"count":20,"type":21},408,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Cerebral radiation necrosis (CRN) is a severe complication of high-dose radiation for brain metastases (BM) or glioma, which can potentially cause significant neurologic symptoms leading to serious morbidity and impaired quality of life (QoL). The first-line therapy for symptomatic CRN (sCRN) is corticosteroids, primarily dexamethasone, which often leads to complications, refractory symptoms, and interference with anti-cancer treatment. Since 2017, bevacizumab, an antibody against Vascular Endothelial Growth Factor (VEGF), has been used in a second-line treatment setting for refractory sCRN. A small randomized clinical trial (RCT) has shown that bevacizumab significantly diminishes cerebral edema on MRI and decreases clinical symptoms of sCRN in irradiated glioma patients. Several non-randomized clinical studies demonstrated a beneficial radiological and clinical effect of bevacizumab in patients with sCRN after irradiation for BM. The optimal first-line treatment for sCRN is currently unknown. Effective and safe first-line treatment of sCRN will optimize the patient's well-being and health-related QoL. Furthermore, minimizing corticosteroid use will benefit the clinical treatment options and outcomes of concomitant or future anti-cancer treatment. This phase III multicenter, open-label, randomized clinical trial compares the clinical efficacy of first-line bevacizumab versus standard-of-care dexamethasone for sCRN in patients with high-grade glioma (HGG) or BM.",[27,28,29,30,31,32,33],"Radiation Necrosis","High Grade Glioma (III or IV)","Brain Metastasases","Radiation Toxicity","Radiation Effect","Radiation Injury","Radiation Injuries",[35,36,37,38,39,40,41,42,43,44,45,46,47],"Cerebral radiation necrosis","High Grade Glioma","Brain Metastases","Bevacizumab","Dexamethasone","Randomized Clinical Trial","First-line treatment","Anti-VEGF monocolonal antibody","Corticosteroids","Radiation induced necrosis","Radiation effects","Radiation injury","Radiation toxicity","RECRUITING","2026-07-09",{"date":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":52},"2025-06-19",{"date":56,"type":21},"2030-07",{"name":58,"class":59},"The Netherlands Cancer Institute","OTHER",6,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100629600","csf-and-blood-plasma-liquid-biopsy-in-patients-with-metastatic-solid-tumours-and-cns-metastases-or-no-cns-metastases-100629600","NCT07476781","CSF and Blood Plasma Liquid Biopsy in Patients With Metastatic Solid Tumours and CNS Metastases or no CNS Metastases","Exploring the Feasibility of Cerebrospinal Fluid (CSF) Liquid Biopsy in Patients With Metastatic Solid Tumours and Leptomeningeal Disease (Cohort A), Parenchymal Brain Metastases (Cohort B), or No Evidence of Central Nervous System (CNS) Metastases (Cohort C): A Pilot Study","Inclusion Criteria:\n\n* Diagnosed with a metastatic solid tumour in one of the following scenarios:\n\n  1. Patients in Cohort A will have previously untreated or progressing leptomeningeal metastatic disease (LMD) with or without parenchymal brain metastases (BrM).\n  2. Patients in Cohort B will have previously untreated or BrM but no evidence of LMD.\n  3. Patients in Cohort C will have progressing extra-cranial metastatic disease with no LMD or BrM.\n* Patient is suitable for lumbar puncture and\u002For has an Ommaya reservoir that is accessible for CSF collection.\n* Patient is eligible at any time point in their treatment course, including whether or not they have already started treatment for LMD. Considering the poor prognosis associated with LMD, rapid clinical deterioration, and the fact that available local and systemic therapies have not been shown to completely eradicate LMD, there is a high likelihood of detecting CSF biomarkers regardless of the timing of assessment. This flexible enrollment strategy is particularly important to support feasibility and recruitment in this less common and clinically challenging population. However, efforts will be made to collect CSF samples prior to treatment initiation and\u002For at the time of disease progression whenever possible.\n* Patients with active brain metastases, defined as newly diagnosed and previously untreated lesions, or lesions that were previously treated and are now progressing.\n* Patients who were previously enrolled in the study and had negative CSF biomarkers may be re-enrolled at a later time point (e.g., upon progression of CNS disease).\n\nExclusion Criteria:\n\n* Inability to understand or unwillingness to provide written informed consent (language barriers are not exclusionary; the use of a translator is permitted).\n* Patients with contraindications to lumbar puncture (e.g., infection at the LP site, uncontrolled bleeding diathesis \\> 1.5\\], severe thrombocytopenia \\[platelet count \\\u003C40,000\u002FµL\\], use of anticoagulant or antiplatelet medications cannot be safely interrupted, significant mass effect with risk of herniation, or presence of vertebral hardware)",{"count":69,"type":21},60,[71],"NA","This is a prospective, single-centre feasibility study of CSF ctDNA conducted at the Sunnybrook Odette Cancer Centre (SOCC), Toronto, Canada, including multiple solid tumor, stratified into cohorts according to CNS disease involvement, including leptomeningeal disease (Cohort A), parenchymal brain metastases (Cohort B), and no evidence of CNS metastases (Cohort C).",[74,29,75],"Solid Tumor Malignancies","Leptomeningeal Disease (LMD)","2026-06-23",{"date":78,"type":52},"2026-06-26",{"date":80,"type":52},"2025-12-12",{"date":82,"type":21},"2026-12",{"name":84,"class":59},"Sunnybrook Health Sciences Centre",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":85},"100641571","phase-2-study-of-radiotherapy-combined-with-platinum-adebrelimab-and-bevazumab-in-the-treatment-of-tnbc-bm-100641571","NCT07638852","Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of TNBC-BM.","A Prospective, Single-arm, Multi-centre, Phase II Clinical Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of Patients With Brain Metastasis of Triple Negativebreast Cancer","ABC-R","Inclusion Criteria:\n\n1. Age ≥18 years and ≤70 years, gender not limited;\n2. ECOG score 0-2;\n3. Pathologically confirmed HR-negative\u002FHER2-negative breast cancer patients with evidence of local recurrence or metastasis, unsuitable for curative surgical resection or radiotherapy; HR-negative is defined as ER-negative and PR-negative, with positive tumor cells accounting for \\\u003C10% of all tumor cells;\n4. Must not have previously used platinum-based drugs, or must have previously used platinum-based drugs (cisplatin or carboplatin and only one regimen) and meet the following definition of platinum sensitivity: no progression during at least 4 cycles of platinum-based therapy, and subsequent disease progression occurring more than 3 months after the last platinum-based therapy;\n5. Expected survival ≥8 weeks;\n6. MRI confirms brain metastasis, with at least one previously untreated intracranial brain parenchymal metastatic lesion with a longest diameter ≥1.0 cm;If the brain metastatic lesion has previously undergone radiotherapy, MRI is required.\n7. Confirm progression after radiotherapy;\n8. Provide sufficient fresh tissue specimens or tumor samples (primary lesion and\u002For metastatic lesions) ≥10 smears before treatment (preferably brain metastatic lesion specimens) for biomarker analysis.\n9. Use mannitol, hormones, or anticonvulsants before the first dose, but the drug treatment dose must be stable for at least one week without needing to be increased.Neurological symptoms stable for ≥1 week are required for enrollment.\n10. Organ function levels must meet the following requirements:\n\n1\\) Complete blood count:\n\n* ANC ≥1.5×10⁹\u002FL;\n* PLT ≥75×10⁹\u002FL;\n* Hb ≥90 g\u002FL (blood transfusion or drug treatment is allowed to ensure hemoglobin levels); 2) Coagulation function: INR ≤1.5, APTT ≤1.5×ULN; PT not exceeding the upper limit of normal.\n\n  3\\) Blood Biochemistry\n* TBIL ≤ 1.5 × ULN;\n* ALT and AST ≤ 3 × ULN (liver metastases ≤ 5.0 × ULN);\n* Cr ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula); 3) Echocardiography: LVEF ≥ 50%; 4) 12-lead ECG: Fridricia-corrected QT interval (QTcF) \\\u003C 470 ms for women and \\\u003C 450 ms for men; 10. Voluntary participation in this study, signing informed consent, good adherence, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Leptomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;\n2. Presence of third-space effusion (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;\n3. Received whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to treatment with the investigational drug, or received endocrine therapy within one week prior to treatment;\n4. Previous use of bevacizumab and PD-1\u002FPD-L1 inhibitors, excluding the following: no disease progression during bevacizumab and PD-1\u002FPD-L1 inhibitor use, investigators believe no drug resistance has been confirmed, and continued use would benefit the subject; short-term bevacizumab use to relieve cerebral edema;\n5. Participation in other drug clinical trials within 2 weeks prior to enrollment;\n6. Concurrent anti-tumor treatment for any other tumor;\n7. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n8. History of any heart disease, including: (1) arrhythmia requiring medication or of clinical significance; (2) myocardial infarction; (3) heart failure; (4) any other heart disease deemed unsuitable for participation in this trial by the investigator;\n9. A known history of allergy to any component of the medications in this regimen;\n10. A history of immunodeficiency, including a positive HIV test, active hepatitis B\u002FC, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n11. A history of a defined neurological or psychiatric disorder, including epilepsy or dementia;\n12. Pregnant or lactating women, women of childbearing age with a positive baseline pregnancy test, or patients who do not wish to use effective contraception throughout the trial;\n13. In the investigator's judgment, a serious comorbidity that would jeopardize patient safety or affect the patient's ability to complete the study (including but not limited to severe hypertension uncontrolled by medication, severe diabetes, active infection, thyroid disease, etc.);\n14. Any other circumstances deemed unsuitable for participation in this study by the investigator.","70 Years",{"count":96,"type":21},58,[98],"PHASE2","This is an open-label, prospective, single-arm, multicenter phase II clinical trial. The aim is to explore the efficacy and safety of radiotherapy combined with cisplatin\u002Fcarboplatin, adebrelimab, and bevacizumab in patients with triple-negative breast cancer and brain metastases.",[101,29],"TNBC, Triple Negative Breast Cancer",[103,104,105,38,106],"TNBC","brain metastatic","radiotherapy","adebrelimab","2026-06-16",{"date":109,"type":52},"2026-06-17",{"date":111,"type":52},"2026-02-02",{"date":113,"type":21},"2028-12-31",{"name":115,"class":59},"Fudan University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":126,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":85},"100643485","impact-of-radiotherapy-immunotherapy-timing-in-nsclc-brain-metastases-100643485","NCT07638709","Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases","Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.","(RT-ICI)","Inclusion Criteria:\n\n* Age ≥ 18 years; no gender restriction;\n* Histologically or cytologically confirmed NSCLC, with brain metastases confirmed by contrast-enhanced cranial MRI;\n* Scheduled to receive radiotherapy combined with a PD-1\u002FPD-L1 inhibitor, in accordance with real-world clinical treatment plans;\n* Negative for driver gene mutations, or positive for mutations but with documented failure of prior targeted therapy;\n* ECOG Performance Status score of 0-2, with an estimated life expectancy of ≥ 3 months;\n* Voluntarily signs the informed consent form and agrees to cooperate with blood\u002Fimaging data collection and follow-up procedures.\n\nExclusion Criteria:\n\n* History of whole-brain radiotherapy, stereotactic radiotherapy for brain metastases, or brain surgery;\n* Presence of contraindications to MRI or inability to tolerate gadolinium-based contrast agents (e.g., severe hepatic or renal insufficiency);\n* Presence of active autoimmune disease requiring systemic treatment, or requirement for long-term use of high-dose immunosuppressive agents;\n* Pregnant or lactating women;\n* Other circumstances deemed by the investigator to involve severe complications or render the patient unsuitable for enrollment.",{"count":125,"type":21},150,"2 Years","OBSERVATIONAL","The goal of this observational study is to learn about the effects of the timing of radiation therapy and immunotherapy in adults with non-small cell lung cancer (NSCLC) that has spread to the brain. The main questions it aims to answer are:\n\n1. Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live?\n2. What medical problems do participants have when receiving these treatments at different times?\n3. How does the timing of treatments affect the body's immune system?\n\nResearchers will compare participants who receive radiation and immunotherapy 30 days or less apart to those who receive them more than 30 days apart to see if the timing affects the treatment's success and safety.\n\nParticipants already receiving radiation and immunotherapy as part of their regular medical care will:\n\n1. Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups.\n2. Give a small blood sample during their routine blood draws.\n3. Have standard magnetic resonance imaging (MRI) scans of their brain.",[130,29],"Non Small Cell Lung","NOT_YET_RECRUITING","2026-06-09",{"date":134,"type":52},"2026-06-10",{"date":136,"type":21},"2026-06-05",{"date":138,"type":21},"2030-06-01",{"name":140,"class":59},"Xiangya Hospital of Central South University",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":160,"locationsCount":4},"100639332","phase-3-precision-radiotherapy-for-refractory-brain-metastases-a-multicenter-study-100639332","NCT07586657","Precision Radiotherapy for Refractory Brain Metastases: A Multicenter Study","Precision Radiotherapy With Novel Technologies and Strategies for Refractory Brain Metastases: A Multicenter Prospective Study","Inclusion Criteria:\n\n1. Pathologically diagnosed non-small cell lung cancer or small cell lung cancer;\n2. Brain metastases diagnosed by contrast-enhanced MRI;\n3. KPS ≥ 60, or KPS ≥ 40 if caused solely by intracranial tumors;\n4. Brain metastases with a diameter ≥ 2 cm or volume ≥ 6 cm³, with 1-3 lesions;\n5. No prior brain radiotherapy;\n6. Able to undergo MRI examination;\n7. Good compliance and ability to lie flat for more than 45 minutes;\n8. No major organ dysfunction, etc.;\n9. Signed informed consent and agreement to receive post-treatment follow-up;\n10. All patients must be willing to provide tumor tissue samples before randomization;\n11. At least one measurable tumor lesion according to RECIST v1.1 or iRECIST criteria.\n\nExclusion Criteria:\n\n1. Other serious illnesses;\n2. Presence of implants in the patient's body, such as cardiac pacemakers, prostheses, or surgical stents, particularly cerebrovascular stents;\n3. Presence of shrapnel, bullets, or other foreign objects anywhere in the body;\n4. Severe back pain when lying supine;\n5. Severe claustrophobia;\n6. Inability to complete treatment or estimated survival \\\u003C 3 months;\n7. Currently participating in other clinical trials for the treatment of brain metastases;\n8. Prior history of intracranial radiotherapy;\n9. Unstable angina, myocardial infarction, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack, pulmonary embolism) within 3 months prior to enrollment;\n10. Persistent arrhythmia (CTCAE grade ≥ 2), atrial fibrillation of any degree, prolonged QTc interval ( \\> 450 ms in males, \\> 470 ms in females);\n11. Refractory hypertension (blood pressure still \\> 150\u002F100 mm Hg despite optimal medical therapy);\n12. Known history of human immunodeficiency virus (HIV) infection;\n13. Pregnant or breastfeeding women;\n14. Receipt of a live vaccine within 30 days prior to the first dose of study drug. Live vaccines include, but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines for injection are typically inactivated virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not permitted;\n15. Active autoimmune disease requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive drugs) within the past 2 years (autoimmune diseases include, for example: autoimmune hepatitis, interstitial pneumonia, uveitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators, etc., i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment and is permitted;\n16. Concomitant medical contraindications to receiving any contrast-enhanced imaging examination (CT or MRI);\n17. Severe hypersensitivity (grade ≥ 3) to the study intervention and\u002For any of its excipients;\n18. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases, or secondary responses to cancer that may lead to increased medical risk and\u002For uncertainty in survival assessment;\n19. Major surgery (as determined by the investigator) or significant trauma within 4 weeks prior to randomization; or elective major surgery planned during the study period. Biopsy for diagnostic purposes is permitted.","75 Years",{"count":150,"type":21},200,[24],"Conventional image-guided techniques (such as cone-beam CT) have poor soft tissue contrast and unsatisfactory treatment outcomes. MRgART offers high-resolution imaging of brain tissue and, by acquiring daily MR images, successfully achieves real-time image monitoring, displaying tumor position and volume changes during treatment. This may improve local control rates for brain metastases, reduce toxicities, and translate into survival benefits. Our research team has already conducted a phase II prospective study and achieved favorable results, with a 1-year local control rate of 100% for intracranial brain metastases, significantly superior to historical controls of conventional radiotherapy, no severe late toxicities, and real-time individualized precision treatment. Based on the phase II study results, this phase III single-arm prospective study was designed. This study aims to conduct a multicenter prospective study to establish an MR-guided adaptive radiotherapy (MRgART) technical platform, enabling real-time monitoring of tumor position and volume changes and individualized plan adaptation. Through technological innovation, we aim to significantly improve local control rates for large and complexly located brain metastases while reducing severe adverse effects such as radiation brain necrosis, thereby laying the technical foundation for precise and safe treatment. This study will establish a new technical system for adaptive radiotherapy (ART) for brain metastases based on per-fraction MR images acquired during radiotherapy, using adaptive radiotherapy to improve target dose coverage and reduce radiation doses to organs at risk such as normal brain tissue. It is anticipated to validate the phase II findings of high local control, low toxicity, and significantly prolonged survival. Based on the obtained results, combined with multicenter clinical practice and application experience, domestic and international expert symposiums and special sessions will be conducted, and a multicenter consensus on MRI-linac guided adaptive radiotherapy for brain metastases from lung cancer will be developed.\n\nFurthermore, this study recognizes that MRI generates high noise levels and that without appropriate hearing protection, repeated treatments may cause hearing damage to patients. Therefore, the study will simultaneously collect hearing-related scales from patients before, during, and after treatment (through pure-tone audiometry tests performed in the otolaryngology department or self-administered pure-tone screening via a mini-program) to explore the impact of performing or not performing strict hearing protection on changes in patients' hearing scales, as well as its effect on treatment interruption or repeated setup.\n\nCompared to conventional cone-beam CT-guided radiotherapy, MRI-guided adaptive radiotherapy still has some shortcomings. MR image acquisition is slow, and after each fraction's images are acquired, they require manual registration with CT images, followed by manual re-contouring and manual plan calculation, and finally, execution requires triple review by physicians, physicists, and therapists. Currently, each patient requires approximately 40 minutes to 1 hour from lying on the treatment couch to the end of treatment. If there are setup errors or significant target volume changes requiring adaptive re-contouring, even more time may be needed to complete the treatment, posing significant challenges to patients' physical strength and mental state, and limiting its potential application value in patients with altered consciousness, the elderly and frail, or those unable to cooperate. Additionally, it consumes substantial medical resources. To address this situation, our research group plans to develop an artificial intelligence-assisted system for target contouring, treatment planning, and treatment decision-making. Based on our center's previously published results, we aim to establish a full-process AI-assisted model for MRgART in the treatment of lung cancer brain metastases, and compare its efficacy and treatment time differences with manual-only radiotherapy delivery. On this basis, we will explore the feasibility of exempting a small subset of patients (approximately 10-20 patients) in the phase III study from conventional CT and MR simulation, contouring targets and generating plans on simulation CT and MRI images, and then directly using ATS (adaptive target shaping based on interfractional target deformation) to generate radiotherapy plans within the MRgART workflow and proceed with subsequent treatment.",[29],"2026-05-07",{"date":156,"type":52},"2026-05-14",{"date":158,"type":21},"2026-04-28",{"date":113,"type":21},{"name":161,"class":59},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":85},"100558020","phase-1-phase-ib-study-of-alpelisib-with-pembrolizumab-in-patients-with-metastatic-breast-cancer-or-melanoma-selena-100558020","NCT06545682","Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)","Inclusion Criteria:\n\n1. Patients must be 18 years or older.\n2. Patients must be willing and able to provide informed consent.\n3. In the dose escalation, patients must have histologically documented locally advanced, unresectable, or metastatic melanoma or TNBC that has progressed on treatments that are known to prolong survival or for which no standard treatment is available or refused such therapy. Presence of active brain metastases is not required. Patients with active metastases as defined below can be eligible in the dose escalation.\n4. In the dose expansion, patients must have histologically documented locally advanced, unresectable, or metastatic melanoma or TNBC that has progressed on treatments that are known to prolong survival or for which no standard treatment is available or refused such therapy.\n\n   1. Melanoma patients without brain metastases who have progressed on an anti-PD-1 or anti-PD-L1-based regimen.\n   2. Melanoma patients with active and untreated brain metastases who have progressed on an anti-PD-1 or anti-PD-L1-based regimen.\n   3. TNBC patients (defined as ER \\\u003C1%, HER2 0, 1+, 2+, and fluorescence in situ hybridization negative) with active untreated brain metastases. Prior treatment with anti-PD-1\u002Fanti-PD-L1 is not required.\n5. All patients must have had a brain magnetic resonance imaging (MRI) scan in the previous 28 days to confirm eligibility for the following cohorts:\n\n   1. Dose escalation and dose expansion Cohort 1: Confirmed absence of untreated brain metastases in patients with histologically confirmed advanced melanoma. Prior surgery for brain metastases must have been completed at least 4 weeks prior study treatment initiation, whole brain radiation therapy must have been completed at least 3 weeks prior to study treatment initiation, and stereotactic radiosurgery must have been completed within 7 days prior to study treatment initiation.\n   2. Dose escalation and dose expansion Cohorts 2 and 3: At least one confirmed measurable untreated brain lesion ≥ 0.5 cm and \\\u003C 3.0 cm in the longest axis.\n6. Has measurable disease based on the RECIST v1.1.\n7. Has adequate organ function as defined in Table 2:\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 4).\n9. Has a life expectancy of at least 12 weeks.\n10. Able to swallow and retain orally administered medication.\n11. In the dose expansion, patients with EC disease must be willing to provide tissue from a newly obtained, safely accessible core or excisional biopsy lesion at pre-treatment and at least one time point while on study treatment. Correlative biopsies will be optional in the dose escalation portion of the study. Newly obtained biopsy is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of study treatment on Day 1 without intervening systemic therapy.\n12. Women of childbearing potential (WOCBP) should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n13. Alpelisib and pembrolizumab can cause fetal harm when administered to a pregnant woman. Therefore, WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of screening through 4 months after the last dose of study treatment. Refer to Pregnancy Assessment Policy MD Anderson Cancer Center (MDACC) Institutional Policy # CLN1114. This includes all female patients between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor such as one of the following:\n\n    1. Postmenopausal (no menses in ≥ 12 consecutive months)\n    2. History of hysterectomy or bilateral salpingo-oophorectomy\n    3. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy)\n    4. History of bilateral tubal ligation or another surgical sterilization procedure\n14. Approved methods of birth control are as follows: hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy, patient\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the study and the study treatment washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n15. Male patients with partner(s) of childbearing potential must agree to use adequate contraception from the time of screening through 4 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Has a history of or active autoimmune disease, as follows: history of inflammatory bowel disease, history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's granulomatosis\\]), motor neuropathy considered of autoimmune origin (e.g., Guillain-Barré syndrome and myasthenia gravis), or history of autoimmune thyroiditis (patients may be eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy).\n2. Has active infection or had a serious general medical condition(s) (such as vascular accident) in the past 6 months.\n3. Any unresolved \\> Grade 1 toxicity (per CTCAE v5.0) from previous anticancer therapy or previously administered agent at the time of enrollment, except for alopecia and Grade 2 anemia (if hemoglobin is \\> 9 g\u002FdL). Note: If the patient received major surgery, he\u002Fshe must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n4. Patients who received chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment.\n5. Presence of any clinically significant gastrointestinal abnormality or other condition(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) that may alter absorption such as malabsorption syndrome or major resection of the stomach or substantial portion of the small intestine based on investigator discretion.\n6. Previous major surgery within 14 days prior to enrollment.\n7. Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).\n8. Established diagnosis of diabetes mellitus type I or uncontrolled type II (based on fasting blood glucose and HbA1c \\[see inclusion criteria #4\\]).\n9. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.\n10. History of severe cutaneous reaction, such as SJS, erythema multiforme (EM), TEN, or drug reaction with eosinophilia and systemic symptoms (DRESS).\n11. Based on average of triplicate 12-lead electrocardiogram (ECG), a mean resting QTc interval using Fridericia formula \\> 450 msec for males and \\> 470 msec for females at screening or a history of congenital long QT syndrome or QTc \\> 480 msec for patients with a bundle branch block.\n12. History or evidence of cardiovascular risk including any of the following:\n\n    1. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to enrollment.\n    2. Class III or IV heart failure as defined by the New York Heart Association functional classification system.\n    3. Known left ventricular ejection fraction \\\u003C 50%.\n    4. Known cardiac metastases.\n13. Poorly controlled hypertension (defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure \\>100 mmHg based on a mean of three measurements taken at approximately 2-minute intervals).\n\n    Note: Initiation or adjustment of antihypertensive medication(s) is permitted if done 30 or more days prior to enrollment.\n14. For dose expansion Cohorts 2 and 3 with active brain metastases:\n\n    1. Patients must not have any of the following on the screening brain MRI:\n\n       * Any untreated brain lesions \\> 3.0 cm in size.\n       * Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to the patient (e.g., brainstem lesions). Patients who undergo local treatment for such lesions may still be eligible for the study.\n    2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of dexamethasone (or equivalent) \\> 4 mg.\n\n       * Poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifestation of neurologic progression due to brain metastases notwithstanding CNS-directed therapy.\n15. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorder that in the opinion of the treating physician or principal investigator (PI) would interfere with cooperation with the requirements of the trial.\n18. Known history of hepatitis B or C or positive test for human immunodeficiency virus.\n19. Has received a live vaccine within 30 days of planned start of study treatment.\n\n    Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; COVID-19 vaccines are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n20. Current use of or anticipated requirement during the study of any prohibited medication(s) (See Section 5.5.2).\n21. History of allergic reactions attributed to compounds of similar chemical or biologic composition to alpelisib and pembrolizumab.\n22. Pregnant or nursing.",{"count":169,"type":21},50,[171],"PHASE1","To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.",[174,175,29],"Melanoma (Skin Cancer)","Breast Cancer","2026-04-13",{"date":178,"type":52},"2026-04-16",{"date":180,"type":52},"2024-10-15",{"date":182,"type":21},"2029-08-03",{"name":184,"class":59},"M.D. Anderson Cancer Center",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":85},"100613550","early-phase-1-a-phase-01-clinical-trial-with-an-expansion-phase-of-gsk5764227-a-b7-h3-targeted-antibody-drug-conjugate-adc-in-patients-with-recurrent-grade-4-glioma-and-patients-with-brain-metastases-100613550","NCT07268053","A Phase 0\u002F1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases","Inclusion Criteria:\n\n* 1\\. Diagnosed with: (a) GBM according to the 2021 WHO criteria, who have progressed on or following standard of care therapy, including maximal safe resection (biopsy allowed if resection was deemed unsafe) and concurrent chemoradiation; OR (b) Brain metastasis requiring surgical resection, whether treated or untreated, and must have well-controlled systemic disease or NED other than the brain metastases, in the opinion of the patient's primary oncologist.\n* 2\\. Has archival or biopsy brain tumor tissue available.\n* 3\\. Has measurable disease (preoperatively) defined as at least one contrast-enhancing lesion with two perpendicular measurements of at least 1 cm.\n* 4\\. Age ≥18 at time of consent.\n* 5\\. Has a performance status of ≤2 on the ECOG scale.\n* 6\\. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):\n* Adequate Bone Marrow Function: Absolute neutrophil count ≥1500\u002FμL (≥1.5 x 109\u002FL), Platelets (at time of surgery) ≥100,000\u002FμL (≥100 x 109\u002FL), Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without pRBC transfusion within prior 2 weeks.)\n* Adequate Hepatic Function: Total Bilirubin ≤1.5x ULN (Participants with Gilbert's syndrome with a total bilirubin \\>1.5x ULN and direct bilirubin ≤1.5x ULN will be permitted.), AST (SGOT) ≤2.5x institutional ULN, ALT (SGPT) ≤2.5x institutional ULN (Participants with liver metastases with ALT ≤5x ULN will be permitted.)\n* Adequate Renal Function: eGFR ≥50 mL\u002Fmin\u002F1.73 m2 (Calculated as individualized eGFR using the CKD-EPI formula \\[2021\\]); If measured or calculated GFR (e.g., creatinine clearance; mGFR) is required or used: ≥60 mL\u002Fmin\n* Adequate Metabolic Function: Albumin ≥2.8 g\u002FdL\n* Adequate Coagulation: INR or PT and aPTT ≤1.5x ULN\n* 7\\. For females of childbearing potential: (a) Must have a confirmed negative serum pregnancy test (β-hCG) before starting study treatment (within 24 hours of first infusion); in rare cases where hCG is suspected to be elevated in the absence of pregnancy (e.g., due to a tumor producing hCG), an ultrasound must be performed to rule out possible pregnancy. (b) Must use a highly effective method of contraception (with a failure rate of \\\u003C1% per year and low user dependency) for at least 28 days prior to treatment, and agree to use such a method during study participation and for an additional 8 months after final study drug administration. (c) Agrees not to breastfeed starting at screening, during study participation, and for 8 months after final study drug administration. (d) Agrees not to donate eggs (ova, oocytes) for the purpose of reproduction starting at screening, during study participation, and for 8 months after final study drug administration.\n* 8\\. For females of non-childbearing potential, is no longer of childbearing potential due to surgical, chemical, or natural menopause.\n* 9\\. For males: (a) Agrees not to donate sperm starting at screening, during study participation, and for 5 months after final study drug administration. (b) Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agrees to remain abstinent starting at screening, during study participation, and for 5 months after final study drug administration; OR Must use a male condom and their female partner must use an additional highly effective method of contraception (with a failure rate of \\\u003C1% per year and low user dependency) starting at screening, during study participation, and for 5 months after final study drug administration.\n* 10\\. Agrees to adhere to Lifestyle Considerations throughout study duration.\n* 11\\. Able and willing to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n* 12\\. Understands the informed consent document and has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.\n\nExclusion Criteria:\n\n* 1\\. Evidence of leptomeningeal metastasis or spinal cord compression.\n* 2\\. Unable to undergo through MRI of the brain with IV contrast.\n* 3\\. Known active systemic bacterial infection (requiring IV antibiotics or fever \\>38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\] (screening of viral infection is not required for enrollment).\n* 4\\. Serious infections within 4 weeks prior to the first infusion of study drug, including but not limited to infectious complications, bacteremia, severe pneumonia treated with IV antibiotics for ≥2 weeks; active infections with therapeutic IV antibiotics within 2 weeks prior to the first infusion of study drug. (Individuals who are receiving or have received prophylactic antibiotics \\[e.g., prophylaxis against urinary infections\\] are allowed).\n* 5\\. Known other concurrent severe psychiatric and\u002For an uncontrolled medical condition that, in the Investigator's judgement, would cause unacceptable safety risks, contraindicate participation in the clinical study, or compromise compliance with the protocol.\n* 6\\. Have any unresolved toxicities from prior therapy greater than NCI-CTCAE v5 Grade 1 at the time of starting study treatment (exceptions include: alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, Grade 2 neuropathy, and any chronic Grade 2 toxicities following discussion with the Principal Investigator).\n* 7\\. Has received treatment with any of the following:\n* a. Orlotamab, enoblituzumab, I-Dxd, or otherB7-H3 targeted agents.\n* b. Investigational agent within 4 weeks prior to the first infusion of study drug.\n* c. Cytotoxic chemotherapy or anticancer drugs within 14 days prior to the first infusion of study drug.\n* d. Monoclonal antibody within 28 days prior to the first infusion of study drug.\n* e. Immunosuppressive agents within 30 days prior to the first infusion of study drug, or requires long-term (30 days or longer) glucocorticoid therapy. NOTE: A stable or reduced daily dose of 8 mg dexamethasone for management of GBM-related edema and its associated symptoms within 14 days prior to dosing is permitted; however, additional weekly CBC monitoring is required during concomitant administration of dexamethasone with GSK5764227, as outlined in the SoA (see section 1.3). NOTE: Low dose corticosteroids (prednisone ≤10 mg\u002Fday or equivalent) may be administered and use of inhaled or topical steroids and prophylactic corticosteroids for procedures are permitted.\n* f. Strong\u002Fmoderate inhibitors of CYP3A4, CYP2D6, P-gp, or BCRP, within 7 days prior to the first infusion of study drug; or need to continue treatment with these drugs (should be discontinued for at least 14 days prior to the first study infusion).\n* g. Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including G-CSF, granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) with 14 days prior to enrollment.\n* 8\\. Major surgery within 4 weeks prior to the first infusion of study drug that, in the Investigator's judgement, would cause unacceptable safety risks.\n* 9\\. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first infusion of study drug.\n* 10\\. Allergy or hypersensitivity to any component of GSK5764227 (ADC, antibody, payload GSK5757810) or its excipients, history of severe allergies (e.g., anaphylactic shock), severe IRRs, or idiosyncrasy to recombinant humanized or mouse proteins.\n* 11\\. History of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* 12\\. Has evidence of current ILD or pneumonitis, or history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids.\n* 13\\. History of moderate to severe lung disease.\n* 14\\. Has serious or poorly controlled hypertension including:\n* a. History of hypertensive crisis.\n* b. Hypertensive encephalopathy.\n* c. Adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first infusion of study drug.\n* d. Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during screening period.\n* 15\\. Has any of the following cardiac examination abnormalities:\n* a. Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree AV block, second-degree AV block, PR interval \\>250 msec).\n* b. Risk factors of prolonged QTc or arrhythmia events, such as: heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death of any direct relative under 40 years old, or any concomitant medications that prolong the QT interval.\n* c. Has QTc \\>450 msec or \\>480 msec for participants with bundle branch block (QTcF can be machine-calculated or manually over-read).\n* d. Known reduced LVEF fraction \\\u003C50%.\n* 16\\. Has severe, uncontrolled or active cardiovascular disorders, including but not limited to:\n* a. Myocardial infarction within 6 months prior to first infusion of study drug.\n* b. Unstable angina within 6 months prior to the first infusion of study drug, not controlled by standard of care therapy.\n* c. Congestive heart failure (NYHA Class III or IV congestive heart failure) within 6 months prior to the first infusion of study drug.\n* d. Cerebrovascular accident or transient ischemic attack within 6 months prior to the first infusion of study drug.\n* e. History of clinically significant (as determined by the Investigator) atrial arrhythmia, not controlled by standard of care therapy.\n* f. History of clinically significant (as determined by the Investigator) ventricular arrhythmia, or occurrence of any clinically significant ventricular arrhythmia during screening.\n* g. Serious arteriovenous thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.) within 3 months prior to the first infusion of study drug (except for implantable venous port, catheter-related thrombosis, or superficial vein thrombosis, which are not considered \"serious\" thromboembolism).\n* 17\\. Known active infectious diseases requiring systemic treatment or known HIV. No active screening needed for active infectious diseases.\n* 18\\. Has documented presence HBsAg, hepatitis B core antibody (HbcAb), or hepatitis B surface antibody (HbsAb) (except for presence of HbsAb attributable to previous vaccination) at screening or within 3 months prior to the first infusion of study intervention.\n* 19\\. Has a positive HCV antibody test result at screening or within 3 months prior to the first infusion of study intervention. NOTE: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled if a confirmatory negative HCV RNA test is obtained and the participant otherwise meets entry criteria.\n* 20\\. Has a positive HCV RNA test result at screening or within 3 months prior to the first infusion of study intervention. NOTE: The HCV RNA test is optional, and participants with a negative HCV antibody test are not required to undergo HCV RNA testing as well.\n* 21\\. Has cirrhosis or current unstable livery or biliary disease (as determined by the Investigator) defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice (individuals with stable non-cirrhotic chronic liver disease \\[including Gilbert's syndrome or asymptomatic gallstones\\] or hepatobiliary involvement of malignancy are permitted).\n* 22\\. History of autoimmune disease that has required systemic treatments in the 2 years prior to screening (individuals with prior history of autoimmune disease must be discussed with the Medical Monitor; replacement therapy is not considered a form of systemic therapy \\[e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary\\]).\n* 23\\. Has any active renal condition (e.g., requirement for dialysis, or any other significant renal condition that could affect the participant's safety \\[renal obstruction successfully managed by stenting is permitted\\]).\n* 24\\. Is unable to adhere to the protocol-defined Schedule of Activities, including requirements for the Follow-up Period of the study, study procedures, restrictions, and requirements as determined by the Investigator.\n* 25\\. Known vaccination or hypersensitivity of any level within 4 weeks prior to the first infusion of study drug.\n* 26\\. Has received any live vaccine within 30 days prior to the first infusion of study drug.\n* 27\\. Is pregnant or breastfeeding.\n* 28\\. Has donated blood or blood products in excess of 500 mL (approximately 1 pint) within 1 month prior to first infusion of study intervention.",{"count":192,"type":21},15,[194],"EARLY_PHASE1","This will be an open-label Phase 0\u002F1 study that will enroll approximately 15 participants, 9 participants with recurrent WHO Grade 4 glioma (rGBM) and 6 participants with brain metastases, who will receive the investigational drug risvutatug rezetecan (GSK5764227), a B7-H3-targeted antibody-drug conjugate (ADC) with the GSK5757810 payload.\n\nThe trial will consist of a Phase 0 component (subdivided into Arms A and B) and an Expansion Phase 1 component. Participants with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component will be eligible to enroll in the Expansion Phase to receive therapeutic dosing of risvutatug rezetecan.",[197,29],"Glioblastoma (GBM)",[199,200],"ADC","Antibody Drug Conjugate","2026-03-04",{"date":203,"type":52},"2026-03-06",{"date":205,"type":52},"2026-02-11",{"date":207,"type":21},"2029-07",{"name":209,"class":59},"Nader Sanai",{"id":211,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":25,"conditions":215,"keywords":216,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":222,"locationsCount":223},"100584398","Inclusion Criteria:\n\nInclusion all patients (both HGG and BM):\n\n1. Age ≥ 18 years old\n2. First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A clear working diagnosis of CRN without evidence of a combination with tumour progression is required\n3. KPS score ≤ 90 and a minimum loss of two points in at least one domain of the NANO scale as compared to the maximum score of at that domain due to sCRN\n4. Maximum daily dexamethasone use of 1 mg\u002Fday for the 8 weeks preceding randomization\n\n   1. Dexamethasone may have been prescribed for various indications, except for managing (ongoing) cerebral edema\n   2. Higher doses of dexamethasone are permitted during the week immediately preceding randomization if used specifically for the treatment of sCRN\n5. Able to understand the patient information, online tests and questionnaires\n6. Written informed consent\n\nInclusion BM:\n\n1\\. BM of solid tumour, including all primary tumour types\n\nInclusion HGG:\n\n1\\. A confirmed histological diagnosis of high-grade diffuse glioma according to WHO 2021 criteria, including: astrocytoma, IDH-mutant, grade 3-4; astrocytoma, IDH-wildtype (sybtype molecular glioblastoma); oligodendroglioma, 1p\u002F19q codeleted, grade 3; diffuse glioma, NEC, grade 3-4; or glioblastoma, IDH-wildtype, grade 4\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study, both for the BM and HGG group:\n\n1. Prior treatment with bevacizumab \\\u003C6 months before diagnosis of sCRN\n2. Life expectancy \\\u003C3 months\n3. Impending radiological or clinical signs of brain herniation necessitating immediate decompressive surgery\n4. Any comorbidity or condition that prevents safe administration of the studied medication, determined by the treating physician, including but not limited to:\n\n   1. Intolerance for murine proteins\n   2. Hypersensitivity or allergy to the active substance or to any of the excipients of bevacizumab or dexamethasone\n   3. Nephrotic syndrome or abnormal renal function\n\n      o Calculated (Cockcroft-Gault) or measured creatinine clearance \\\u003C30 mL\u002Fmin; urine dipstick for proteinuria ≥ 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein\u002F24 hr.\n   4. Clinical significant cardiovascular disease\n\n      * Uncontrolled hypertension (systolic BP \\>150mmHg and\u002For diastolic \\>100mmHg) despite the use of ≥ 3 antihypertensive drugs\n      * Previous hypertensive crisis, hypertensive encephalopathy or previous reversible posterior leukoencephalopathy syndrome (RPLS)\n      * Non tumour related vascular event (e.g. cerebral or cardiac ischemia\u002Fbleeding (including transient ischemic attack, cerebral ischemia, unstable angina or angina requiring intervention, myocardial infarction), peripheral arterial thrombus, peripheral artery disease, deep venous thrombosis, lung embolism) \\\u003C 6 months\n      * History of aortic aneurysm or dissection\n      * Congestive heart failure NYHA II-IV\n   5. History of gastro-intestinal fistula, perforation or abscess \\\u003C 6 months\n   6. History of bleeding\n\n      * Relevant pulmonary hemorrhage\u002F hemoptysis \\\u003C 1 month or the presence of a pulmonary lesion with a high risk of bleeding (= central lung tumour and\u002For untreated squamous cell carcinoma) according to the treating physician\n      * Active gastrointestinal bleeding \\\u003C 6 months\n      * Evidence of recent intracranial hemorrhage on MRI brain \\\u003C3 months. Asymptomatic presence of hemosiderin depositions or punctate hemorrhage in the tumour do not serve as a ground for exclusion\n   7. Excess risk of bleeding\n\n      * History or evidence of inherited bleeding diathesis or significant coagulopathy with the risk of bleeding\n      * Decreased platelet count \\\u003C 75x109\u002FL\n   8. Risk of wound healing complications\n\n      * Significant non-healing wound, (peptic) ulcer or bone fracture\n      * Major surgical procedure (including open biopsy) or significant traumatic injury within 28 days prior to first study treatment or planned surgical procedure within the following next 28 days after planned study inclusion\n      * Minor surgical procedure, stereotactic\u002Fcore biopsy, fine needle aspiration within 7 days prior to first study treatment\n   9. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein\u002F24 hr.\n   10. Previous, current or planned high dose radiotherapy in the abdomen\n   11. Pregnancy or lactation. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to randomization. WOCBP and female partners of male patients must comply with adequate contraception methods as requested by the study protocol\n   12. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the study treatment, affect patient compliance or place the patient at high risk for treatment-related complications according to the treating physician\n   13. Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another interventional study In case of uncertainty, consult the principal investigator of the study site.",{"count":20,"type":21},[24],[27,28,29,30,31,32,33],[35,36,37,38,39,40,41,42,43,44,45,46,47],"2026-02-24",{"date":219,"type":52},"2026-02-25",{"date":54,"type":52},{"date":56,"type":21},{"name":58,"class":59},5,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":85},"100605417","phase-2-combined-gamma-knifelinac-radiosurgery-for-large-brain-tumors--metastases-100605417","NCT07162246","Combined Gamma Knife\u002FLinac Radiosurgery for Large Brain Tumors \u002F Metastases","Combined Gamma Knife\u002FLinac Hypofractionated Stereotactic Radiosurgery for Large Intracranial VolumEs (GK-LIVE): A Prospective Phase II Single-Arm Trial","GK-LIVE","Inclusion Criteria:\n\n* Presence of up to two large intracranial lesions\n* Up to 10 (previously untreated, or progressing after previous treatment) brain metastases at the time of enrollment on the diagnostic MRI (which includes the ILLs) to be treated with SRS\u002FHSRS\n* Age =\\> 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Expected survival \\>3 months\n* Patients that are deemed suitable for both GK and Linac based treatment\n* Patients that are able to hold systemic cancer chemotherapy\u002Fimmunotherapy at least 2 days prior and following an SRS fraction\n\nExclusion Criteria:\n\n* Prior SRS to the ILLs\n* Prior WBRT, or plan for concurrent WBRT with the protocol treatment\n* Presence or history of any leptomeningeal\u002Fpachymeningeal disease\n* Metastatic disease within the ventricles of the brain or corpus callosum\n* Small cell, hematopoietic or germ cell primaries\n* Patient with absolutely contraindications for MRI\n* Severe symptoms that preclude MRI or treatment using standard procedures for Linac or GK\n* Pregnant or lactating patient\n* Inability or unwillingness to undergo informed consent or post-treatment follow-up",{"count":69,"type":21},[98],"When cancer spreads to the brain, doctors often use a precise type of radiation therapy called stereotactic radiosurgery (SRS) to treat these tumors. This treatment can effectively control brain tumors while helping protect healthy brain tissue. However, when brain tumors or the areas where tumors were surgically removed are larger, treatment outcomes in terms of side effects and tumour control can become worse. Specifically, standard SRS on larger areas can have lower tumour control and higher risk of side effects, particularly a condition called radiation necrosis, which can cause swelling and damage in nearby healthy brain tissue.\n\nCurrently at Sunnybrook, large brain tumors are typically treated with SRS spread over 5 daily treatments using a machine called a linear accelerator. While this approach works well for many patients, it may be possible to improve results by combining two different types of radiation therapy machines - the linear accelerator and another specialized machine called the Gamma Knife.\n\nIn this study, the investigators want to test a new treatment approach where patients first receive 4 daily treatments using the linear accelerator, followed by a 1-2 week break, and then a final treatment using the Gamma Knife. The break between treatments allows the study doctors to take new scans and precisely target any remaining tumor, which may shrink during the break, thereby potentially reducing the amount of healthy brain tissue exposed to radiation. The Gamma Knife is also particularly good at delivering very precise radiation while sparing nearby healthy tissue. Lastly, there may be unique biological mechanisms between the two technologies that could be taken advantage of, by combining the technologies in the participant's treatment plan, to improve cancer control.\n\nThe investigators believe this combined approach might help achieve better tumor control while reducing the risk of side effects compared to using just the linear accelerator. This study will help the investigators understand if this new treatment strategy is safe and effective for patients with large brain tumors or surgical cavities, and whether it leads to better outcomes than the current treatment approach.",[236,29,237],"Brain (Nervous System) Cancers","SRS","2025-09-05",{"date":240,"type":52},"2025-09-09",{"date":242,"type":52},"2025-07-14",{"date":244,"type":21},"2030-06",{"name":84,"class":59},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":253,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":85},"100572045","study-investigating-the-role-of-routine-screening-and-molecular-characterisation-of-brain-metastasis-in-the-management-of-high-risk-metastatic-breast-cancer-100572045","NCT06728150","Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer","STORM","Inclusion Criteria:\n\n* Metastatic breast cancer with visceral, nodal or bone metastasis\n* Human epidermal growth factor type2 (HER2-positive disease)\n* Triple negative breast cancer (TNBC) with metastatic disease\n* Oestrogen Receptor Positive disease (ER-positive disease) after second-line therapy and cyclin dependent kinase 4\u002F6 inhibitors (CDK4\u002F6 inhibitors), plus more than two sites of bone metastasis or visceral metastasis\n* Diagnosis of metastatic disease in the last 3 months and free of symptoms or disease (with brain MRI confirmation) • Medicare Eligible\n\nExclusion Criteria:\n\n* Symptomatic brain metastasis\n* Inability to provide consent\n* Inadequate organ function\n* Pregnancy.","FEMALE",{"count":255,"type":21},45,"The purpose of this study is to improve outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging.\n\nIn patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. However, there is emerging evidence suggesting that patients diagnosed without symptoms of brain metastases may have a better outcome than those with symptoms such as headache, vomiting and weakness.\n\nIn current practice, if signs and symptoms suggestive of brain metastases are to develop, then the doctor will arrange imaging of the brain, which may be a computerised tomography (CT scan) and\u002For a magnetic resonance imaging (MRI) scan. Should brain metastasis be detected, local radiotherapy, chemotherapy or targeted treatments will be offered.\n\nWhen initially diagnosed with metastatic or advanced breast cancer, participant will or would have undergone a brain scan by either MRI or CT during normal standard full-body CT scan (chest, abdomen and pelvis) imaging. In this study, each time participants have a regular full-body CT scans to assess treatment progress, they will also have an additional CT scan of the brain.\n\nParticipants will have a total of 12 extra brain scans, with scans taking place every three months for the first 2 years, and every 6 months for the following years. These scans will occur at the same location as your current treatment. There will be no extra costs involved in the study and participants will be in the study for 4 years and following their follow-up details will be collected from medical records.\n\nSome participants who develop brain metastases during the followup will have neurosurgery to remove these metastases. The investigators will collect either fresh or archived tissues and a cerebrospinal fluid (CSF) sample at the time of surgery from those patients.\n\nIf the treating investigators do not think neurosurgery is an option, they will ask participants to have a lumbar puncture for the collection of CSF. The purpose of this optional CSF collection is to take a liquid biopsy to check for markers (or biomarkers) potentially expressed by the breast cancer tumour cells in the brain. Participants will also be asked to provide a blood sample as well as old tumour from breast surgery (other metastatic tumour tissue).\n\nThe information obtained from this component of the study will not impact a parcipants current management, but it will help researchers to develop better treatments for breast cancer brain metastases in the future.",[258,29],"Breast Cancer Metastatic",[260],"Breast cancer brain metastases","2024-12-10",{"date":263,"type":52},"2024-12-11",{"date":265,"type":21},"2024-12-01",{"date":267,"type":21},"2029-12-31",{"name":269,"class":59},"Monash University",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":85},"100568718","phase-2-a-multicenter-single-arm-open-label-study-evaluating-the-safety-and-efficacy-of-ak112-combined-with-chemotherapy-as-first-line-treatment-for-non-squamous-nsclc-patients-with-brain-metastases-and-negative-driver-genes-ivo-brain-100568718","NCT06684873","A Multicenter, Single-arm, Open-label Study Evaluating the Safety and Efficacy of AK112 Combined With Chemotherapy as First-line Treatment for Non-squamous NSCLC Patients With BRAIN Metastases and Negative Driver Genes (IVO BRAIN)","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the clinical study and had not received any systemic anti-tumor treatment (including any chemotherapy, targeted therapy, immunotherapy, etc.)\n2. Male or female subjects aged 18-75 years (including the cutoff) at the time of signing the ICF\n3. patients with histopathologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer (nsqNSCLC) with brain metastases\n4. Patients were required to provide a genetic testing report that showed negative driver genes, i.e., no EFGR sensitive gene mutation, no ALK or ROS1 gene fusion, no BRAF V600E sensitive gene mutation, and no RET gene fusion\n\n5\\. If not, qualified tumor tissue or blood should be provided for genetic testing. 5) MRI confirmed brain parenchymal metastasis, with ≥3 brain lesions\n\n6: Or patients with 1-2 brain lesions who are not suitable for local treatment or refuse local treatment. At least one measurable brain lesion had to be at least 5mm in diameter. 6) For asymptomatic brain metastases or those with controlled intracranial hypertension after treatment with dehydration, medication could be continued at enrollment or during the study to maintain symptom stability\n\n7\\) At least one measurable target lesion as assessed by investigator according to RECIST v1.1 within 4 weeks before the first dose\n\n8\\) ECOG PS score of 0-1\n\n9\\) predicted survival time ≥12 weeks\n\n10\\) good vital organ function\n\n11\\) Female subjects must have a negative serum pregnancy test within 3 days before treatment, agree to use effective contraception during and after treatment for 6 months, and refrain from breastfeeding during treatment\n\n12: Male patients provided consent to use contraception during treatment.\n\nExclusion Criteria:1) known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 \\> 3) Or known hypersensitivity to carboplatin\u002Fpemetrexed components\n\n2: any active infection requiring systemic anti-infective therapy within 14 days before the first dose\n\n3\\) myocardial infarction with uncontrolled arrhythmia (including QTc interval ≥450 ms in men and ≥470 ms in women) within 6 months before the first dose (QTc interval was calculated with Fridericia's formula)\n\n4: Or grade III-IV cardiac dysfunction according to the New York Heart Association (NYHA) standard or left ventricular ejection fraction \\\u003C50% by echocardiography\n\n5\\) subjects with ≥ grade 2 CTCAE peripheral neuropathy\n\n6\\) subjects had uncontrolled or symptomatic hypercalcemia (\\>1.5 mmol\u002FL ionized calcium or calcium \\>12 mg\u002FdL or corrected serum calcium \\>ULN)\n\n7\\) subjects with previous or screening history of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired pulmonary function, which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity according to the investigator's judgment\n\n8\\) untreated active hepatitis B subjects (HBsag-positive and HBV-DNA \\> 1000 copies \u002FmL (200 IU\u002FmL) or higher than the lower limit of detection, whichever is higher) and, for those with hepatitis B, required to receive anti-HBV treatment for the duration of the study treatment\n\n9: Active hepatitis C subjects (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection)\n\n10: Or patients with known active syphilis infection (excluding patients with positive heterologous antibody test, negative non-heterologous antibody test and inactive infection confirmed by clinical judgment)\n\n11 Or a known history of human immunodeficiency virus (HIV) positivity or screening positive for HIV\n\n12\\) the subject has a known active or suspected autoimmune disease. Subjects who were in a stable state and did not require systemic immunosuppressive therapy were allowed to enroll.\n\n13\\) patients with other active malignant tumors within 5 years or at the same time. Localized tumors that had been cured for more than 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, were eligible for inclusion.\n\n14\\) Recipients of a live or attenuated vaccine within 28 days before the first dose, or having a plan to receive such vaccine during the study period. However, inactivated virus vaccines for seasonal influenza are permitted\n\n15\\) radical radiotherapy or whole brain radiotherapy (WBRT) to the skull within 3 months before the first dose\n\n16\\) subjects with spinal cord compression that could not be cured by surgery and\u002For radiotherapy\n\n17\\) patients with deep vein thrombosis, current anticoagulant or platelet therapy, or previous use of antiangiogenic drugs for deep vein thrombosis or severe bleeding\n\n18\\) poorly controlled (poorly controlled defined as BP ≥160\u002F100 MMHG despite optimal hypertension treatment)\n\n19\\) had undergone major surgery within 28 days before the first dose (major surgery was defined for this study as a procedure requiring at least 3 weeks of recovery before being able to undergo study treatment)\n\n20\\) who are participating in another clinical study, or who have participated in any other clinical trial (including drugs, devices, etc.) and received intervention within 3 months before screening or within 5 half-lives (whichever is longer)\n\n21\\) candidates for or prior recipients of organ or bone marrow transplantation\n\n22\\) subjects had a known history of psychotropic drug abuse or drug use\n\n23\\) subjects with any factors considered by the investigator to be ineligible for the trial.\n\n\\-",{"count":277,"type":21},55,[98],"A multicenter, single-arm, open-label study evaluating the safety and efficacy of AK112 combined with chemotherapy as first-line treatment for non-squamous NSCLC patients with BRAIN metastases and negative driver genes",[281,29],"NSCLC","2024-11-10",{"date":284,"type":52},"2024-11-12",{"date":286,"type":21},"2024-11-02",{"date":288,"type":21},"2027-12-01",{"name":290,"class":59},"Sun Yat-sen University",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":85},"100562555","ai-guided-prognostication-and-cranial-radiotherapy-optimization-in-egfr-tki-treated-non-small-cell-lung-cancer-patients-with-baseline-brain-metastases-100562555","NCT06604689","AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases","Artificial Intelligence-guided Prognostication and Cranial Radiotherapy Optimization in First-line Third-generation EGFR-TKI-treated EGFR-mutant Non-small Cell Lung Cancer With Baseline Brain Metastases: a Multicenter, Observational Study","Inclusion Criteria:\n\n* Pathologically confirmed non-small cell lung cancer;\n* clinical stage IV (AJCC, 8th edition, 2017);\n* EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;\n* age≥18 years old;\n* KPS score≥70;\n* brain metastases at diagnosis;\n* complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;\n* received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);\n* willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;\n* informed consent of the patient.\n\nExclusion Criteria:\n\n* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);\n* Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;\n* EGFR sensitive mutations were negative or EGFR mutation status was not detected.\n* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.",{"count":299,"type":21},800,"The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy.\n\nParticipants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.",[302,29],"NSCLC (Advanced Non-small Cell Lung Cancer)","2024-11-08",{"date":284,"type":52},{"date":306,"type":52},"2024-09-30",{"date":308,"type":21},"2025-10-01",{"name":115,"class":59},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":253,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100561185","phase-2-jk-1201i-in-triple-negative-breast-cancer-patients-with-brain-metastases-100561185","NCT06586866","JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases","A Multicenter, Single-Arm, Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases","Inclusion\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.\n2. Female aged ≥18 years.\n3. Has ECOG PS of ≤1.\n4. Life expectancy ≥ 3months.\n5. Histological or cytological confirmation of triple-negative breast cancer (TNBC).\n6. At least one prior chemotherapy regimen with anthracyclines and taxanes for advanced disease.\n7. Has at least 1 measurable brain metastatic lesion according to RANO-BM.\n8. Adequate biological function.\n9. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.\n\nExclusion\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Patients who have received prior anti-cancer treatment within 4 weeks.\n2. . Patients must not have previously received JK-1201I or any other form of irinotecan, SN38.\n3. Hypersensitivity to any ingredient of JK-1201I and Topotecan.\n4. Current use or any use in the last two weeks of strong CYP3A-enzyme inducers \u002F in the last two weeks of strong CYP3A-enzyme inhibitors and \u002F or strong UGT1A inhibitors.\n5. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.\n6. History of other malignancies within last 5 years.\n7. History of immunodeficiency disease, or positive human immunodeficiency virus antibody.\n8. Severe infections within 4 weeks before the first use of the study drug.\n9. Active hepatitis B virus infection, or active hepatitis C virus infection.\n10. Patients who received surgery within last 4 weeks before the initiation of study treatment.\n11. Patients with brain stem, meningeal or spinal cord metastasis.\n12. Severe symptoms by tumor aggressive important organ.\n13. Uncontrolled hydrothorax and ascites.\n14. Uncontrolled concomitant systemic disorder as defined in the protocol.\n15. Serious cardiac condition or uncontrolled high blood pressure.\n16. History of mental illness, drug abuse, alcoholism.\n17. Pregnant or breast-feeding.\n18. Other conditions that the investigator considers unsuitable to participate in this clinical trial.",{"count":318,"type":21},25,[98],"This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.",[322,29],"Triple Negative Breast Cancer (TNBC)","2024-09-04",{"date":325,"type":52},"2024-09-19",{"date":327,"type":21},"2024-09-26",{"date":329,"type":21},"2026-10-26",{"name":331,"class":332},"JenKem Technology Co., Ltd.","INDUSTRY"]