[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-metastasis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,42,72,100,132,159,185,211,236,259,284,307,333,355,374,400],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100528328","phase-3-18f-fluc-petmr-in-patients-with-brain-mets-100528328",false,"NCT06159335","18F-FLUC PET\u002FMR in Patients With Brain Mets","Use of 18F-Fluciclovine PET for Discerning Tumor From Treatment Change in Patients With Brain Metastases Undergoing Immunotherapy","Inclusion Criteria:\n\n* Age 18 years or older\n* Able and willing to provide informed consent\n* Has a brain metastasis diagnosis with at least one single visible contrast enhancing metastatic lesion on brain MRI\n* Received radiation therapy at some point in the last 2 years\n* Is currently being treated with or has been treated with any other concurrent systemic therapy (multi-modal therapy) in the past 6 months, which would include immunotherapy, targeted therapy, or systemic chemotherapy, immunotherapy, or chemotherapy following radiation therapy.\n* Patients are eligible for the study if their most recent standard-of-care MRI, used to assess disease location and extent, raises the question of tumor recurrence versus treatment-related changes. This concern can be noted by the radiologist or other members of the multidisciplinary care team, such as during a multidisciplinary conference. Additionally, if there are clinical concerns based on evolving exam findings or symptoms, and the treating physician suspects progression versus treatment-induced changes, the patient is also eligible for the study.\n* Be able to lie still for 30-60 minutes during the imaging procedure\n* Willing and able to undergo PET\u002FMRI or PET\u002FCT\n* Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:\n\n  * The subject has their own prescription for the medication\n  * The informed consent process is conducted prior to the self-administration of this medication\n  * They come to the research visit with a driver\n\nExclusion Criteria:\n\n* Subject unable or unwilling to provide informed consent\n* Subject is pregnant\n* Subject with contraindication(s) to or inability to undergo a PET\u002FMR or PET\u002FCT\n* Known allergy to 18F-Fluciclovine or any of its excipients","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The goal of this clinical trial is to use new imaging methods to help in finding out whether the imaging shows that there is a tumor in people with a brain metastasis. The main question it aims to answer is whether positron emission tomography (PET) and magnetic resonance imaging (MRI) find cancerous tissue better than other types of imagining.\n\nParticipants will undergo a single PET\u002FMRI scan, followed by a separate MRI scan with a tracer. Study participation will last about 3 hours.",[26,27,28],"Brain Metastasis","Radiation Therapy","Immunotherapy, Active","RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":33},"2024-01-10",{"date":37,"type":20},"2027-06",{"name":39,"class":40},"University of Wisconsin, Madison","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100641388","early-phase-1-qh101-cell-injection-in-patients-with-brain-brain-spinal-meninges-and-spinal-cord-metastatic-malignant-solid-tumors-100641388","NCT07656103","QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors","Exploratory Clinical Study of Dose Escalation for QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors Three Dose Groups Are Established: 1×10⁷ enTCR Vδ2T Cells Per Infusion (Low Dose), 3×10⁷ enTCR Vδ2T Cells Per Infusion (Medium Dose), and 6×10⁷ enTCR Vδ2T Cells Per Infusion (High Dose). The Dose Escalation Rules Are as Follows: The First Enrolled Subject Receives Low-dose Cell Infusion. If no Dose-limiting Toxicity (DLT) Events Occur After Infusion, the Second Enrolled Subject Receives Medium-dose Infusion; the Medium and Hig","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. ECOG ≤2 or KPS ≥60;\n3. Life expectancy ≥8 weeks as assessed by the investigator;\n4. Pathologically and\u002For histologically confirmed malignant tumors with brain, meningeal, and spinal cord metastases that have failed standard therapy or lack standard treatment options may be considered for enrollment;\n5. Intracranial metastases must meet the following characteristics:\n\n   Unresectable by craniotomy for solitary\u002Ffocal (≤3 lesions)\u002Fmultiple (\\>3 lesions) intracranial metastases; or inoperable leptomeningeal or spinal cord metastases; Inclusion Criteria Intracranial lesions that progressed after standard treatment, including whole-brain radiotherapy\u002Fstereotactic radiosurgery (WBRT\u002FSRS), and are not suitable for repeat radiotherapy;\n6. For brain\u002Fspinal cord parenchymal metastases, contrast-enhanced MRI must show at least one measurable lesion (according to iRANO criteria); for patients with meningeal lesions only, those deemed likely to benefit from this study by investigator judgment may also be considered for inclusion (efficacy assessed using RANO-LM criteria);\n7. Basic normal bone marrow reserve function and normal hepatic and renal function (laboratory tests must meet the following criteria prior to first QH101 administration):\n\n   White blood cell count (WBC) ≥ 3 × 10⁹\u002FL; Lymphocyte count (LY) ≥ 0.8 × 10⁹\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Platelet count (PLT) ≥ 90 × 10⁹\u002FL; Alanine aminotransferase (ALT) \\& aspartate aminotransferase (AST) \\\u003C 1.5×ULN; Serum creatinine (Cr) \\\u003C 1.5×ULN; Total bilirubin \\\u003C 1.5×ULN; PT \\& APTT ≤ 1.25×ULN.\n8. Pregnancy test must be negative for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;\n9. Ability to understand trial requirements and procedures, and willingness to participate in the clinical study as required;\n10. Signing of the trial informed consent form.\n\nExclusion Criteria:\n\n1. Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;\n2. Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;\n3. Patients with metastases in the brainstem and high cervical spinal cord, including midbrain, pons, medulla oblongata, and C1\u002F2 segments of the cervical spinal cord;\n4. Patients with significant mass effect from intracranial lesions and signs of increased intracranial pressure (such as severe headache, projectile vomiting, papilledema, altered consciousness, or imaging showing significant edema, midline shift ≥1 cm, compression of peribrain cisterns such as suprasellar cistern, quadrigeminal cistern, interpeduncular cistern, or ambient cistern);\n5. Patients with primary or secondary epilepsy\u002Fepileptic syndrome that is difficult to control with medication;\n6. Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric\u002Fsocial conditions limiting patient compliance with study requirements;\n7. Known psychiatric disorders or substance abuse disorders that may affect compliance with trial requirements;\n8. Currently receiving any other investigational treatments;\n9. Diagnosed with an immunodeficiency;\n10. Patients with active infections requiring systemic treatment;\n11. Inability to undergo magnetic resonance imaging (MRI);\n12. Severe cardiovascular damage: history of New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction or stroke within 6 months after first dosing, or clinically significant arrhythmias requiring treatment at screening;\n13. Allergic to immunotherapy or related cellular therapies;\n14. Previously received CAR-T or other cellular immunotherapies;\n15. Other reasons that the investigator considers make the patient unsuitable for participation in this study.",{"count":50,"type":20},7,[52],"EARLY_PHASE1","QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence.",[26,55,56],"Meningeal Metastasis","Spinal Cord Metastasis",[58,59,60,61],"TCR","BTN","γδT","allogeneic cell therapy","NOT_YET_RECRUITING","2026-06-14",{"date":65,"type":33},"2026-06-18",{"date":67,"type":20},"2026-05-31",{"date":69,"type":20},"2027-05-31",{"name":71,"class":40},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":41},"100640060","phase-2-sac-tmt-combined-with-bevacizumab-in-tnbc-with-brain-metastases-100640060","NCT07623577","Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases","An Open-label, Single-arm, Multi-center Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Combined With Bevacizumab in Triple-negative Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n1. Age ≥ 18 years old, regardless of gender;\n2. ECOG Performance Status of 0-2;\n3. Histologically or cytologically confirmed HR-negative and HER2-negative breast cancer; there is evidence of metastasis; not suitable with curative surgery or radiation therapy; HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \\\u003C 10%; HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-);\n4. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy; For lesions with prior radiotherapy, progressive disease post radiotherapy must be confirmed by MRI\n5. Any conditions deemed by the investigator to make the patient unnecessary for local therapy;\n6. Life-expectancy ≥ 3 months;\n7. Intraventricular catheter shunt to reduce intracranial pressure or treatment with mannitol, hormones, and anticonvulsants was permitted prior to the first dose, but the dose of medication was stable for at least one week without increment and neurological symptoms were stable for ≥1 week;\n8. Adequate function of major organs meets the following requirements:\n\n(1)Blood routine: ANC≥1.5×109\u002FL; PLT≥75×109\u002FL; Hb ≥90 g\u002FL(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) ; (2)Coagulation: INR≤1.5; APTT≤1.5×ULN ; (3)Blood biochemistry：TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); Urea nitrogen ≤1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL \u002F min (Cockcroft-Gault formula) ; (4)Cardiac ultrasound: LVEF≥50%; (5)12-lead ECG: females QTcF interval \\\u003C 470 ms and males \\\u003C 450 ms; 9. Willing to join the study, sign informed consent, have good compliance and can cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Pial metastases confirmed by MRI or lumbar puncture;\n2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);\n3. Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment;\n4. Prior use of bevacizumab or other anti-angiogenic agents is prohibited, except for the following scenarios:a)No disease progression occurred during bevacizumab treatment, no confirmed drug resistance was identified, and the investigator deems continued use beneficial for the participant;b)Short-course bevacizumab was administered solely for the management of cerebral edema\n5. Has received prior therapy with topoisomerase I inhibitors and ADC drugs regardless of targeting any target;\n6. Participation in any other clinical trials 2 weeks before enrollment;\n7. Strong inhibitors or inducers of CYP3A4 are not permitted during the study, which includes the 4-week period prior to the first administration.\n8. Concurrent use of any other Anti-cancer drugs;\n9. Bleeding tendency such as acute gastrointestinal bleeding, persistent bleeding disease or coagulation dysfunction;\n10. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma;\n11. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, a current ILD or non-infectious pneumonia, or a suspected ILD or non-infectious pneumonia that could not be ruled out by imaging at the time of screening; Clinically severe lung impairment due to co-occurring lung disease, including but not limited to any underlying lung disease (pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs , or prior total pulmonary resection;\n12. History of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal disease that interferes with delayed corneal healing;\n13. Severe infection within 4 weeks prior to initial dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Active infections requiring systemic anti-infective therapy were present within 2 weeks prior to initial administration;\n14. History of heart disease:\n\n    1. Arrhythmias requiring medical treatment or of clinical significance;\n    2. Myocardial infarction;\n    3. Heart failure;\n    4. Any heart diseases that investigator believes not suitable for this study;\n15. History of allergy or hypersensitivity to any of the study drugs or study drug components;\n16. History of immunodeficiency including HIV-positive, active hepatitis B\u002FC, other acquired, congenital immunodeficiency disease or history of organ transplantation;\n17. A clear history of neurological or mental disorders, including epilepsy or dementia;\n18. According to the investigators' judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs);\n19. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation;\n20. Any condition which in the investigators' opinion makes the subjects unsuitable for the study participation.",{"count":80,"type":20},24,[82],"PHASE2","This is a single-arm, multi-center phase II study to evaluate the safety and efficacy Sacituzumab Tirumotecan (Sac-TMT) plus bevacizumab in triple-negative breast cancer patients with brain metastases. Twenty-four participants are planned to be enrolled. The eligible patients should have histologically or cytologically confirmed TNBC with BM.",[85,26],"TNBC",[87,88,89,85,90],"trop2","Bevacizumab","Sacituzumab Tirumotecan","brain metastasis","2026-05-28",{"date":93,"type":33},"2026-06-03",{"date":95,"type":33},"2026-01-01",{"date":97,"type":20},"2027-12",{"name":99,"class":40},"Fudan University",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100635403","nk-cell-therapy-for-malignant-solid-brain-tumors-100635403","NCT07552233","NK Cell Therapy for Malignant Solid Brain Tumors","NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors","Inclusion Criteria:\n\n1. Male or female, age 18-70 years old (both ends included)\n2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment\n3. Karnofsky Performance Status (KPS) ≥ 60%\n4. Life expectancy \\> 4 weeks, and must be able to undergo an MRI with contrast\n5. Patients who completed radiotherapy or systemic therapies (including temozolomide\u002Fbevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)\n6. Dexamethasone dose ≤ 4 mg\u002Fday or equivalent corticosteroid dose, or no dexamethasone administered\n7. Must have adequate organ and marrow function as defined below:\n\n   * White blood cell count (WBC) ≥ 3 x 10\\^9\u002FL\n   * Absolute neutrophil count (ANC) \\> 1 x 10\\^9\u002FL\n   * Hemoglobin (Hb) ≥ 90 g\u002FL\n   * Platelet (PLT) ≥ 80×10\\^9\u002FL\n   * Albumin transaminase (ALT) \\& albumin transaminase (AST) \\\u003C 1.5 × institutional upper limit of normal (ULN)\n   * Serum creatinine (Cr) \\\u003C 1.5 x institutional ULN\n   * Total bilirubin \\\u003C 1.5 x institutional ULN\n   * PT \\& PTT ≤ 1.25 x institutional ULN\n8. No obvious hereditary diseases\n9. Normal cardiac function with left ventricular ejection fraction \\>55%\n10. No bleeding and coagulation disorders\n11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and\u002For there aren't any indications of meningitis\n12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n13. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Active hepatitis B or C virus, HIV infection, or other untreated active infection\n2. Pregnant and lactating women\n3. Participants with organ failure\n4. Participants with a chronic disease requiring immunologic or hormonal therapy\n5. Participants with an allergy to immunotherapy and related cells\n6. Participants with uncontrolled intercurrent illness\n7. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n8. Participants with a history of organ transplantation or who are awaiting organ transplantation","70 Years",{"count":109,"type":20},27,[111],"NA","This is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of the immunological effects of NK cell infusion in the tumor microenvironment and peripheral blood.",[114,115,116,26,117],"Malignant Solid Brain Tumors","Glioblastoma (GBM)","Glioblastoma Multiforme (GBM)","Malignant Meningioma",[114,119,120,121],"Immunotherapy","Natural Killer Cell","NK Cell","2026-04-20",{"date":124,"type":33},"2026-04-27",{"date":126,"type":20},"2026-04",{"date":128,"type":20},"2030-12-31",{"name":130,"class":40},"Peking University Third Hospital",4,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100627503","phase-2-a-phase-ii-clinical-study-of-utidelone-and-bevacizumab-with-or-without-etoposide-in-patients-with-brain-metastases-from-malignant-solid-tumors-100627503","NCT07449481","A Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors","A Single-Arm, Open-Label, Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors","Inclusion Criteria:\n\n* Subjects must provide informed consent for the trial and voluntarily sign the written informed consent form (ICF) prior to the study.\n* Aged 18-75 years, male or female.\n* Patients with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC):The pathological type of NSCLC must be adenocarcinoma.For advanced NSCLC patients with positive EGFR sensitive mutations, ALK fusion, ROS1 fusion, RET fusion, BRAF V600E, or NTRK fusion mutations, they must have experienced disease progression after adequate targeted therapy for the corresponding mutation AND after at least one platinum-based chemotherapy regimen, or be intolerant to platinum-based therapy.Patients with NSCLC without driver gene mutations and patients with SCLC must have experienced disease progression after platinum-based chemotherapy with or without PD-1\u002FPD-L1 inhibitors, or be intolerant to the aforementioned therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-2.\n* At least one measurable lesion in the central nervous system (CNS).\n* Patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy, or immunotherapy within 4 weeks prior to enrollment.\n* All toxicities related to prior anti-tumor treatment must have recovered to ≤ Grade 1 (CTCAE v5.0), except for alopecia of any grade, which is permitted.\n* CNS patients, based on screening brain Magnetic Resonance Imaging (MRI), must meet one of the following conditions:Untreated brain metastases not requiring immediate local therapy；Previously treated brain metastases, assessed by the investigator as having progressed after prior local CNS therapy and without clinical manifestations requiring immediate local therapy.\n* Routine blood tests within 1 week prior to enrollment are essentially normal (based on the normal ranges of each research center's laboratory):\n\nWhite blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL；\n\nAbsolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL；\n\nPlatelet count (PLT) ≥ 100 × 10\\^9\u002FL；\n\nHemoglobin ≥ 9.0 g\u002FdL (Patients may receive blood transfusion or erythropoietin treatment to meet this criterion.)；\n\n-Liver and kidney function tests within 1 week prior to enrollment are essentially normal (based on the normal ranges of each research center's laboratory):\n\nTotal bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN)；\n\nAlanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)；\n\nAspartate aminotransferase (AST\u002FSGOT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)；\n\nCreatinine clearance (Ccr) ≥ 60 ml\u002Fmin；\n\n* Expected survival ≥ 12 weeks.\n* Men of reproductive potential and women of childbearing potential must agree to use reliable contraception from signing the ICF until 180 days after the last dose of study drug. Women of childbearing potential must have a negative serum pregnancy test result within ≤7 days before the first dose of study drug.\n\nExclusion Criteria for Lung Cancer with Brain Metastases:\n\n* History of other malignancies (including primary brain or leptomeningeal tumors) within the past 5 years, except for cured basal cell skin carcinoma or cervical carcinoma in situ.\n* Prior use of Utidelone injection or Bevacizumab.\n* Imaging shows tumor invasion of major blood vessels, unclear demarcation from vessels, or judged by the investigator as having a high probability of fatal massive hemorrhage due to tumor invasion of important vessels during the study (major thoracic vessels include the thoracic aorta, left pulmonary artery, right pulmonary artery, 4 pulmonary veins, superior vena cava, inferior vena cava, and aorta).\n* Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of study drug, or scheduled elective surgery during the trial period.\n* History of Grade 3 or higher severe neurological adverse reactions related to prior anti-microtubule drug use.\n* Any untreated brain lesion \\> 2.0 cm, unless discussed and approved for enrollment by the investigator.\n* Ongoing use of systemic corticosteroids to control brain metastasis symptoms, with a total daily dose \\> 2 mg dexamethasone (or equivalent). However, a chronic stable dose ≤ 2 mg dexamethasone daily (or equivalent) may be permitted after discussion and approval by the investigator.\n* Any brain lesion deemed to require immediate local treatment, including (but not limited to) lesions where increased size in an anatomical location or possible treatment-related edema may pose a risk to the patient (e.g., brainstem lesions). Patients receiving local treatment remain eligible for the study based on criteria described in the CNS inclusion criteria, as determined by screening contrast brain MRI.\n* More than 2 episodes of seizures within 4 weeks prior to enrollment.\n* Poorly controlled hypertension, or history of hypertensive crisis or hypertensive encephalopathy.\n* History of hemoptysis within 6 months prior to enrollment, or evidence of bleeding tendency or significant coagulation dysfunction within the past month.\n* Current use of full-dose warfarin or equivalent agents, or use of aspirin (325 mg\u002Fday) within 10 days.\n* Major surgery, open biopsy, or significant traumatic injury within 28 days, or anticipated need for such during the study.\n* Severe gastrointestinal toxicity prior to the first dose of study drug that has not recovered to below Grade 2; or confirmed presence of other clinically uncontrolled acute or chronic gastrointestinal diseases.\n* History or presence of interstitial lung disease, emphysema, chronic obstructive pulmonary disease, pulmonary interstitial fibrosis, drug-induced interstitial lung disease, or radiation pneumonitis; or uncontrolled respiratory symptoms prior to the first dose of study drug.\n* Clinically significant cardiovascular disease, including but not limited to:\n\nHeart failure, myocardial ischemia or infarction, unstable angina, arrhythmia within the past 6 months or currently present, and New York Heart Association (NYHA) Class III-IV cardiac function.\n\nBaseline ECG showing prolonged QT\u002FQTc interval (QTcF: \\>450 ms for males, \\>470 ms for females).\n\nBaseline echocardiogram (ECHO) showing left ventricular ejection fraction (LVEF) ≤ 50%.\n\nPoorly controlled hypertension despite medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).\n\nHistory of cardiac surgery such as angioplasty, coronary artery bypass graft.\n\n* Peripheral neuropathy ≥ Grade 2, or skin abnormalities such as rash ≥ Grade 2 requiring treatment prior to the first dose of study drug, or any toxicity from prior anti-tumor treatment that has not recovered to ≤ Grade 1 per CTCAE v5.0 (except for Grade 2 alopecia).\n* History of drug abuse of psychotropic substances and inability to abstain, or patients with psychiatric disorders.\n* Pregnant or breastfeeding women.\n* Presence of any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that may interfere with treatment or follow-up.\n* Known or suspected allergy to any study drug or excipient.\n* Any reason that precludes the performance of brain magnetic resonance imaging with contrast.\n* Any other condition deemed by the investigator to make the patient unsuitable for participation in this trial.\n* Other conditions contraindicating the use of corticosteroids.","75 Years",{"count":141,"type":20},56,[82],"Brain metastasis represents one of the worst prognostic outcomes in advanced malignant tumors. Approximately 10% to 40% of patients with solid tumors develop brain metastases, a incidence rate significantly higher than that of primary malignant brain tumors. Over 80% of patients present with multiple brain metastases at diagnosis, often precluding surgical intervention.\n\nBrain metastases typically occur in the late stages of cancer. Patients have often received multiple prior therapies and developed resistance to first- and second-line drugs, leaving limited pharmacological options. The rapid growth of intracranial tumors poses an immediate threat to life. Consequently, radiotherapy and surgery currently form the cornerstone of clinical management for these patients. Thus, developing effective systemic therapies is an urgent and unmet medical need .\n\nUtidelone, a new-generation epothilone anticancer agent, has demonstrated good efficacy and safety. Previous studies indicate that utidelone achieves higher concentrations in most tissues, including the brain, compared to plasma, suggesting its ability to readily cross the blood-brain barrier . Furthermore, a Phase III clinical trial in metastatic breast cancer showed that utidelone in combination with capecitabine significantly improved the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to capecitabine alone in patients previously treated with anthracyclines and taxanes .\n\nA separate Phase II study demonstrated that bevacizumab combined with carboplatin achieved a central nervous system objective response rate (CNS ORR) of 63%, with a median PFS of 5.62 months and a median OS of 14.1 months in breast cancer patients with brain metastases . Regarding safety, utidelone has a relatively low incidence of adverse reactions aside from peripheral neurotoxicity .\n\nBased on this evidence, this proposed study aims to evaluate the efficacy and safety of utidelone and bevacizumab, combined with etoposide for breast cancer cohorts or without etoposide for lung cancer cohorts, in patients with malignant tumor brain metastases.",[145,26],"Malignant Solid Tumor",[147,148,149],"NSCLC","SCLC","brain metastases","2026-03-26",{"date":152,"type":33},"2026-04-01",{"date":154,"type":20},"2026-05-01",{"date":156,"type":20},"2030-02-01",{"name":158,"class":40},"Tianjin Medical University Cancer Institute and Hospital",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100447154","stereotactic-radiotherapy-in-oligometastatic-brain-disease-a-randomised-phase-iii-study-comparing-hypofractionated-stereotactic-radiation-therapy-310-gy-to-the-historical-single-dose-radiosurgery-120-to-25-gy-with-medico-economic-evaluation-100447154","NCT05102747","Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.","OligoBM-01","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* WHO performance status 0 or 1;\n* Patient eligible for SRT after a multidisciplinary committee decision; Patient with BMs from radioresistant cancer (renal cell carcinoma, sarcoma, melanoma) is eligible\n* Patient having up to 5 BM of solid tumours with an histologically proven diagnoses; patients who have had a metastasectomy and having 1 to 4 BM lesions is eligible (ANOCEF recommendations); post-operative cavity must be treated by radiosurgery according to local procedures with respect of non-inclusion criteria\\* (cavity will not be analyzed for efficacy)\n* Presence of at least one and no more than 5 target lesions for SRT, measuring between 10 and 25 mm. In the event of synchronous BM, lesions measuring less than 10mm or more than 25mm (1 to 4 lesions) will be treated at the discretion of the investigator\n* Max cumulative GTV of 30cm3\n* Normal complete blood count (CBC)\n* Absence of bleeding BM or meningeal carcinomatosis;\n* Symptomatic BM are allowed\n* DS-GPA score:\n\n  * Renal cancer: DS-GPA 2,5 or more\n  * Breast cancer: DS-GPA 2,5 or more\n  * Melanoma: DS-GPA 1.5 or more\n  * Gastro-instestinal (GI) cancer: DSGPA 3 or more\n  * Adenocarcinoma lung cancer: DS-GPA 2 or more (DS-GPAmol)\n  * Squamous lung cancer : DS-GPA 2,5 or more (DS-GPAmol)\n  * For cancers where the DS-GPA score is not applicable, the patient is eligible if eligibility criteria are met\n* Patient with no concomitant systemic treatment; in case of ongoing systemic treatment, wash out period of 3-7 days before and after SRT, depending of drug and at the discretion of investigator;\n* Patient sufficiently cooperating to perform the treatment with the use of a thermoformed mask;\n* Patient whose neuropsychological abilities allow to follow the requirements of the protocol;\n* Female with childbearing potential must use adequate contraception\n* Signed informed consent formOligoBM-01 Trial - ID-RCB number: 2021-A01622-39 - version 3.1 dated from 2023-06-22 Page 9 of 51\n* Patients affiliated to the social security system\n\nExclusion Criteria:\n\n* Patients with current or past history small cell lung cancer, germ-cell tumours, lymphoma, leukemia and multiple myeloma within the last 5 years;\n* Patients with metastases in the brain stem, or within 1 cm of the optic apparatus;\n* Patients with an associated neurodegenerative disease;\n* Any symptoms not attributable to BM or cancer disease requiring long term corticosteroid use (regardless of dose);\n* Contraindication to perform the brain MRI or gadolinium or iodinated contrast;\n* Known hypersensitivity to the contrast product or to any their excipients\n* Patients with previous brain stereotactic irradiation\n* Whole brain irradiation history;\n* Haemorrhagic metastasis;\n* Ongoing anti angiogenic treatment (treatment should be held 3-7 days before irradiation and re-initiated 3-7 days after irradiation for patient to be eligible);\n* Patients with too close brain lesions for whom a treatment plan on one target metastasis delivers a dose \\> 5 Gy on other concomitant metastasis ;\n* Patient deprived of liberty or under guardianship;\n* Known pregnancy or breastfeeding\n* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study;\n* Participation in a therapeutic trial for less than 30 days.\n* Patient deprived of freedom or under guardianship",{"count":167,"type":20},504,[111],"Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of \"oligometastatic\" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.\n\nStereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.\n\nHSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.\n\nCommon adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.\n\nTo investigators knowledge, SRS and HSRT have not been prospectively compared.",[26,171],"Oligoprogression",[173,174],"Stereotactic radiosurgery","Fractionated stereotactic radiotherapy","2026-01-26",{"date":177,"type":33},"2026-01-27",{"date":179,"type":33},"2023-01-12",{"date":181,"type":20},"2031-01",{"name":183,"class":40},"Centre Francois Baclesse",15,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":41},"100620263","feasibility-of-a-cognitive-stepped-care-program-for-adults-with-brain-metastases-100620263","NCT07355348","Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases","Codesign of a Cognitive Stepped Care Program (CSCP) to Enhance Quality of Life in Adults With Brain Metastases: Evaluation of Feasibility, Acceptability and Preliminary Efficacy","Patients:\n\nInclusion Criteria:\n\n* Diagnosed with a brain metastasis for any primary cancer\n* Receiving follow-up care in the Brain Metastases Clinic\n* Adult (≥ 18 years)\n* Able to speak, read, and write in English\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* History of significant developmental\u002Flearning disability or psychiatric disorder, acquired neurological disorder (e.g., traumatic brain injury)\n* Poor performance status (ECOG ≥ 3)\n* Life expectancy \\\u003C 3 months\n\nCaregivers:\n\nInclusion Criteria:\n\n* Self-identified or identified by consenting patient as a primary caregiver for a person with brain metastases receiving follow-up in the Brain Metastases Clinic\n* Adult (≥ 18 years)\n* Able to speak, read, and write in English\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n• N\u002FA\n\nStaff:\n\nInclusion Criteria:\n\n* Currently working as a clinician or administrative staff member in the Brain Metastases Clinic\n* Adult (≥ 18 years)\n* Able to speak, read, and write in English\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n• N\u002FA",{"count":193,"type":20},140,[111],"Background: Cognitive symptoms are common and often severe in patients with brain metastases, significantly impacting their quality of life and ability to manage cancer care. Currently, there is no standard approach for routinely assessing and managing these symptoms in oncology clinics.\n\nObjective: This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of the Cognitive Stepped Care Program (CSCP) in a Brain Metastases Clinic.\n\nMethods: This is a prospective, mixed-methods feasibility study involving patients with brain metastases, their caregivers, and clinic staff. Patients will undergo routine cognitive symptom screening using a standardized tool. Based on symptom severity, they will receive tiered interventions ranging from no support, to education materials, to computerized cognitive testing with individualized debrief, with group strategy training and\u002For neuropsychological consultation, as needed. Patients will complete questionnaires before and after the intervention regarding their symptoms and quality of life. Patients, caregivers and staff will provide their feedback about the intervention through questionnaires and interviews.\n\nOutcomes: Primary outcomes include feasibility and acceptability of the CSCP. Secondary outcomes include preliminary changes in cognitive symptoms, self-efficacy, and quality of life.\n\nSignificance: This study will inform the potential integration of a structured cognitive support program into standard care for patients with brain metastases and may provide a model for similar interventions in other oncology settings.",[197,26],"Brain Metastases",[199,149,90,200,201],"cancer-related cognitive impairment","stepped care","symptom management","2026-01-12",{"date":204,"type":33},"2026-01-21",{"date":206,"type":33},"2026-01-09",{"date":208,"type":20},"2026-06",{"name":210,"class":40},"University Health Network, Toronto",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":21,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100618285","phase-3-evaluation-of-neoadjuvant-stereotactic-radiosurgery-srs-and-multi-fraction-srs-alone-for-the-treatment-of-large-brain-metastases-100618285","NCT07329634","Evaluation of Neoadjuvant Stereotactic Radiosurgery (SRS) and Multi-fraction SRS Alone for the Treatment of Large Brain Metastases","Randomized Evaluation of Neoadjuvant Stereotactic Radiosurgery (SRS) and Multi-fraction SRS Alone for the Treatment of Large Brain Metastases: A Polish Multicenter Trial Protocol","RENESANS","Inclusion Criteria:\n\n* Age ≥18 years.\n* At least one brain metastasis appropriate for resection and not previously treated with SRS.\n* Lesions ≥2.5 cm and ≤6 cm in largest dimension.\n* Index lesion(s) will be treated, as outlined in the treatment section of the protocol.\n* Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate Neo-SRS, i.e., the ability to lie flat in a stereotactic head mask.\n* Any non-index lesion or lesions for which there is no possible resection must measure ≤4.0 cm in maximal dimension on the contrast MRI or CT brain scan obtained ≤35 days prior to pre-registration. Unresected lesions will be treated with SRS or mfSRS.\n* KPS \\>60\n* MRI confirms 1-10 lesions, one of which one is the index lesion. Each non-index lesion (up to nine) must measure ≤4 cm in maximal extent on contrast MRI and not otherwise require resection.\n* Known active or history of invasive primary non-central nervous system (CNS) cancer based on a documented histopathological diagnosis within the past three years.\n* Patient can tolerate surgery and SRS.\n* History\u002Fphysical examination within 14 days prior to registration.\n* A negative urine or serum pregnancy test (in persons of childbearing potential, defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months) within ≤14 days prior to registration.\n* Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment during this study to prevent pregnancy.\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* No resectable lesion ≥2.5 cm.\n* Unresectable \\>4 cm lesion.\n* Previous whole brain irradiation.\n* Progressive brain lesion treated with SRS.\n* Previous resection of brain metastases.\n* Leptomeningeal disease.\n* Lesion diameter \\>6.0 cm, or more than 20 lesions in the brain.\n* Required emergency decompressive surgery for life-threatening intracranial hypertension (with a preference towards adjuvant SRS\u002FmfSRS protocols).\n* Prior diagnosis of malignant brain tumor.\n* Pediatric patients (age \\\u003C18 years), pregnant women, and patients who are unable to give informed consent will be excluded.",{"count":220,"type":20},98,[23],"The prospective, two-arm, randomized, controlled, multicentric phase III RENESANS trial is designed to compare the efficacy and safety of neoadjuvant stereotactic radiosurgery (Neo-SRS) versus multi-fraction stereotactic radiosurgery (mfSRS) in patients with large brain metastases, with the primary objective of evaluating the incidence of central nervous system composite events.",[26],[225,173,226,227],"Brain metastasis","Neoadjuvant therapy","Multi-fraction therapy","2026-01-06",{"date":206,"type":33},{"date":231,"type":20},"2026-01",{"date":233,"type":20},"2032-09",{"name":235,"class":40},"Maciej Harat",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":255,"leadSponsor":257,"locationsCount":41},"100619350","phase-2-sacituzumab-tirumotecan-plus-third-generation-tki-withwithout-radiotherapy-for-egfr-mutant-nsclc-brain-metastases-100619350","NCT07343479","Sacituzumab Tirumotecan Plus Third-Generation TKI With\u002FWithout Radiotherapy for EGFR-Mutant NSCLC Brain Metastases","A Clinical Study of Sac-TMT for Injection Combined With Third-Generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) ± Radiotherapy in Subjects With EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer and Brain Metastasis Who Have Failed Prior EGFR-TKI Treatment","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF), regardless of gender;\n* Histologically or cytologically confirmed non-squamous NSCLC, and metastatic (Stage IV);\n* Confirmed EGFR sensitizing mutation including exon 19 deletion (19-Del) or exon 21 point mutation (L858R);\n* Subject has previously received EGFR-TKI therapy for locally advanced or metastatic disease and has experienced radiological PD;\n* Subjects with new or previously diagnosed brain metastasis confirmed by contrast-enhanced cranial MRI;\n* ECOG performance status scale of 0 or 1;\n* Life expectancy ≥ 12 weeks;\n* Adequate organ and bone marrow function;\n\nExclusion Criteria:\n\n* Tumor histology or cytology confirms combined small cell lung cancer (SCLC), neuroendocrine carcinoma, carcinosarcoma components, or squamous cell carcinoma;\n* Known leptomeningeal metastases;\n* Other malignant tumors within 3 years prior to the first dose (except for tumors cured by local treatment, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, etc.);\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>470 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention;\n* Uncontrolled systemic diseases as judged by the investigators;\n* Clinically severe pulmonary impairment due to concurrent lung disorders, including but not limited to any underlying lung disorder (e.g., pulmonary embolism within 3 months before the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, sicca syndrome, sarcoidosis, etc.), or prior pneumonectomy;\n* Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage;\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease;\n* Active infection requiring systemic therapy;\n* Active hepatitis B \\[hepatitis B surface antigen (HBsAg) positive, requiring hepatitis B virus deoxyribonucleic acid (HBV-DNA) testing; HBV-DNA ≥500 IU\u002FmL or above the lower limit of detection, whichever is higher\\] or hepatitis C \\[hepatitis C antibody positive, and hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection\\];\n* Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;\n* History of allogeneic tissue\u002Fsolid organ transplant.",{"count":244,"type":20},45,[82],"This is a prospective, open-label, multi-center, single-arm clinical trial",[248,249,26],"NSCLC (Advanced Non-small Cell Lung Cancer)","EGFR Gene Mutations",[251],"NSCLC with brain metastasis",{"date":253,"type":33},"2026-01-15",{"date":154,"type":20},{"date":256,"type":20},"2029-12-20",{"name":258,"class":40},"Zhejiang Cancer Hospital",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":41},"100560883","phase-2-elimination-of-ptv-margins-based-on-mri-guided-adaptive-stereotactic-radiotherapy-for-non-small-cell-lung-cancer-with-brain-metastasis-100560883","NCT06582940","Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis","Inclusion Criteria:\n\n* Aged 18-75 years\n* Histologically or cytologically confirmed non-small cell lung cancer\n* 1-10 metastases on contrast-enhanced MRI\n* Radiotherapy for extracranial lesions is permitted\n* Tyrosine kinase inhibitors (TKI) are permitted in patients with progression of\n* intracranial metastases during previous TKI therapy\n* Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells\u002Fmm3; creatinine clearance rate(CCR) ≥45 mL\u002Fmin; Platelet count≥50,000 cells\u002Fmm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN\n* Informed-consent\n\nExclusion Criteria:\n\n* Small cell carcinoma of lung\n* Intracranial metastases needed surgical decompression\n* Patients with contraindications for MRI\n* Previous radiotherapy or excision for intracranial metastases\n* Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months\n* Uncontrolled hypertension (systolic \\> 150mmHg and\u002For diastolic \\> 100mmHg)\n* Major surgery within 28 days or minor surgery or needle biopsy within 48 hours\n* Urine protein 3-4+, or 24h urine protein quantitative \\>1g\n* Severe uncontrolled disease\n* Uncontrollable seizure or psychotic patients without self-control ability\n* Women in pregnancy, lactation period\n* Other not suitable conditions determined by the investigators",{"count":266,"type":20},168,[82],"This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis.",[270,271,26],"MRI-guided Adaptive Radiotherapy","Non-small Cell Lung Cancer",[273,274,90],"MRI-guided radiotherapy","lung cancer","2025-11-14",{"date":277,"type":33},"2025-11-17",{"date":279,"type":33},"2024-03-01",{"date":281,"type":20},"2026-03-01",{"name":283,"class":40},"Sun Yat-sen University",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":21,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":306,"locationsCount":4},"100581568","efficacy-of-the-rayerknife-x-stereotactic-radiotherapy-system-in-the-treatment-of-brain-metastases-100581568","NCT06852001","Efficacy of the RayerKnife X Stereotactic Radiotherapy System in the Treatment of Brain Metastases","A Prospective, Multi-center, Single-Arm Study on the Efficacy of the RayerKnife X Stereotactic Radiotherapy System in the Treatment of Brain Metastases","Inclusion Criteria:\n\n1. Age between 18 and 80 years (inclusive), regardless of gender.\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n3. Diagnosis of brain metastasis confirmed by histopathological examination and\u002For imaging, and deemed suitable for stereotactic radiotherapy according to the investigator's judgment.\n4. Tumor diameter of brain metastasis ≤ 4 cm, with ≤ 10 metastatic lesions.\n5. At least one measurable tumor lesion as defined by the RECIST 1.1 criteria for assessment of treatment efficacy.\n6. Ability to understand the study objectives, voluntarily consent to participate, and sign a written informed consent; willingness to undergo all necessary examinations and follow-up assessments.\n\nExclusion Criteria:\n\n1. Expected survival time \\\u003C 6 months.\n2. Patients requiring surgical treatment or other local therapies for the target lesions during radiotherapy.\n3. Patients who have received other local treatments (including radiofrequency ablation, cryoablation, particle therapy, etc.) within 30 days prior to screening, or those who have received systemic therapy (chemotherapy, endocrine therapy, immunotherapy) within 14 days or less than five half-lives of a drug prior to screening (whichever is longer).\n4. Patients who have previously received radiotherapy at the same site or for the same lesion.\n5. Patients with extensive metastasis, severe cachexia, or clear signs of malignant cachexia.\n6. Patients deemed by the investigator to be unable to tolerate radiotherapy.\n7. Patients with psychiatric disorders or who are unable to accurately describe their condition or cooperate with required examinations.\n8. Patients with systemic active infections or infections of the pericardium or lungs.\n9. Patients with severe liver or renal dysfunction, or those with significant concurrent diseases in other systems.\n10. Patients with septic hemorrhagic shock.\n11. Patients with esophageal cancer at risk for deep ulceration or perforation, or those with large pleural effusion in lung cancer or significant ascites in abdominal tumors.\n12. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or unwilling to take appropriate contraceptive measures (acceptable methods include hormonal therapies (oral, implant, etc.), intrauterine devices, barrier methods (spermicide + condom), spermicide + diaphragm\u002Fcervical cap, abstinence, etc.).\n13. Low blood counts (leukocyte count \\\u003C 2.0 × 10⁹\u002FL, platelet count \\\u003C 50 × 10⁹\u002FL, or hemoglobin \\\u003C 80 g\u002FL), or abnormal laboratory values exceeding the normal range with clinical significance.\n14. Participation in any drug or medical device clinical trial within 30 days prior to screening or currently enrolled in another clinical study.\n15. Any other condition deemed by the investigator to be inappropriate for participation in this study.","80 Years",{"count":293,"type":20},34,[111],"The goal of this clinical trial is to evaluate the efficacy of stereotactic radiotherapy in the treatment of brain metastases. The main question it aims to answer is: Did stereotactic radiotherapy improve LC rate in the treatment of brain metastases? Participants will be recorded for local control rates during follow-up.",[26,297],"SRS",[299],"Radiotherapy","2025-02-24",{"date":302,"type":33},"2025-02-28",{"date":304,"type":20},"2025-03-01",{"date":281,"type":20},{"name":158,"class":40},{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100551591","phase-2-sacituzumab-govitecan-combined-with-head-radiotherapy-for-her2-negative-breast-cancer-brain-metastases-100551591","NCT06462079","Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases","A Phase II Clinical Study of Sacituzumab Govitecan Combined With Head Radiotherapy for the Treatment of Brain Metastases From Her2-negative Breast Cancer","Inclusion Criteria:\n\n1. Have a definitive pathologic diagnosis of breast cancer with subtype Her2- (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);\n2. Have a measurable intracranial lesion;\n3. Age ≥ 18 years;\n\nExclusion Criteria:\n\n1. Patients with cerebrospinal membrane metastases;\n2. Patients with acute\u002Fsubacute hemorrhagic metastasis;\n3. Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10\\^9\u002FL, PLT ≤ 90 x 10\\^9\u002FL, Hb ≤ 90g\u002FL; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal;\n4. Presence of serious and\u002For uncontrolled comorbidities that may affect participation: 1) allergy to study medications or adjuvant materials; 2) history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases; 3) serious concomitant illnesses;\n5. Pregnant and lactating female patients; female patients of childbearing age who are unwilling to use effective contraception during the trial period;\n6. Patients who are unable to complete enhanced contrast MRI;\n7. Patients who have been treated with Sacituzumab Govitecan and are resistant to the drug;\n8. Any other condition that, in the opinion of the investigator, makes the patient ineligible for study participation.",{"count":315,"type":20},43,[82],"The incidence of brain metastasis of Her2-negative breast cancer is high, which seriously affects the prognosis of patients.The treatment of brain metastasis of Her2-negative breast cancer is still tricky. The local efficacy of head radiotherapy for breast cancer brain metastases is remarkable, and systemic tumor progression in patients with brain metastases is the main reason for treatment failure. Sacituzumab Govitecan is the only Trop-2 antibody-coupled drug (ADC) approved for the treatment of unresectable locally advanced or metastatic Her2-negative breast cancer. However, the objective remission rate of Sacituzumab Govitecan for intracranial metastatic lesions has not been satisfactory. This study is an open, uncontrolled phase II clinical study to observe the efficacy and safety of Sacituzumab Govitecan combined with intracranial radiotherapy in the treatment of patients with brain metastases from Her2-negative breast cancer, in order to find a more effective treatment method.",[26],[320,321,225,322,323],"Breast cancer","Her2- (Human Epidermal Growth Factor Receptor 2 Negative)","Sacituzumab Govitecan","Radiation therapy","2024-06-12",{"date":326,"type":33},"2024-06-17",{"date":328,"type":20},"2024-06-15",{"date":330,"type":20},"2027-07-15",{"name":332,"class":40},"Guangzhou Medical University",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":340,"minAge":4,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":41},"100541515","brain-metastasis-development-mechanism-in-bcbm-patients-100541515","NCT06330870","Brain Metastasis Development Mechanism in BCBM Patients","Evaluation of Brain Metastasis Development Mechanism in Patients With Breast Cancer With Brain Metastasis(BCBM)","Inclusion Criteria:\n\n* Breast cancer\n* Brain metastasis curative surgery patient\n\nExclusion Criteria:\n\n* Gamma Knife surgery patient","FEMALE",{"count":19,"type":20},[111],"This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis",[345,26],"Breast Cancer","2024-03-19",{"date":348,"type":33},"2024-03-26",{"date":350,"type":33},"2023-04-06",{"date":352,"type":20},"2027-12-31",{"name":354,"class":40},"Samsung Medical Center",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":41},"100532256","phase-2-shr-a1921-combined-with-bevacizumab-in-triple-negative-breast-cancer-with-brain-metastases-100532256","NCT06210438","SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases","SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases：a Prospective, Single-arm, Single-center Phase II Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years old, both genders\n2. ECOG Performance Status of 0-2\n3. Pathological tests confirm HR-negative\u002FHER2-negative breast cancer；there is evidence of local recurrence or metastasis；not suitable with curative surgery or radiation therapy；HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \\<10%；HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-)\n4. Must have life-expectancy of ≥ 3 months\n5. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy；\n6. Intraventricular catheter shunting or mannitol、steroid hormone、anticonvulsant drug is allowed before enrollment, but the dose of drug should be stable for at least one week and the neurological symptoms are stable for ≥1 week\n7. Adequate function of major organs meets the following requirements (1)Blood routine\n\n   * ANC≥1.5×109\u002FL；\n   * PLT≥75×109\u002FL；\n   * Hb≥90 g\u002FL(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation\n   * INR≤1.5，APTT≤1.5×ULN (3)Blood biochemistry\n   * TBIL≤1.5 × ULN;\n   * ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN);\n   * Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL \u002F min (Cockcroft-Gault formula) (4)Cardiac ultrasound\n   * LVEF≥50%; (5)12-lead ECG:\n   * females QTcF interval \\<470msec and males \\<450ms;\n8. Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture\n2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);\n3. Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment\n4. Has received prior therapy with bevacizumab and TROP-2 ADC drugs\n5. Participation in any other clinical trials within 2 weeks of enrollment\n6. Concurrent use of any other Anti-cancer drugs\n7. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma\n8. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study\n9. History of allergy or hypersensitivity to any of the study drugs or study drug components\n10. History of immunodeficiency including HIV-positive, active hepatitis B\u002FC, other acquired, congenital immunodeficiency disease or history of organ transplantation\n11. A clear history of neurological or mental disorders, including epilepsy or dementia\n12. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation\n13. According to the investigator\\'s judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)\n14. Any condition which in the investigator\\'s opinion makes the subjects unsuitable for the study participation",{"count":80,"type":20},[82],"This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases",[85,26],"2024-01-17",{"date":368,"type":33},"2024-01-18",{"date":370,"type":20},"2024-02-01",{"date":372,"type":20},"2026-06-30",{"name":99,"class":40},{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":4,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":41},"100247838","a-prospective-study-of-the-impact-of-hippocampal-avoidance-during-whole-brain-radiotherapy-on-neurocognitive-function-decline-100247838","NCT02504788","A Prospective Study of the Impact of Hippocampal Avoidance During Whole Brain Radiotherapy on Neurocognitive Function Decline","Inclusion Criteria:\n\n* Patients with pathologically-confirmed non-hematopoietic malignancy who are referred for therapeutic or prophylactic WBRT\n* Good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky Score (KPS) at least 70 %\n* The number and extent of brain metastatic lesions should be no more than three metastatic foci with a greatest diameter no more than 4 cm\n\nExclusion Criteria:\n\n* Patients with MRI-identified metastasis within 5 mm perihippocampally\n* Clinical suspicion of leptomeningeal spreading\n* History of prior radiotherapy including stereotactic radiosurgery delivered to brain\u002Fhead region for any reasons","84 Years",{"count":382,"type":20},100,[111],"Whole brain radiotherapy (WBRT) has long been a practical and effective therapeutic modality for various settings of management in radiation oncology. For example, the indications for WBRT should include brain metastasis or metastases, the setting of prophylactic cranial irradiation (PCI) used mainly for patients with limited-stage small cell lung cancer, and even some patients with extensive-stage small cell lung cancer. The rationales for WBRT are essentially based on that it can target both microscopic and gross intracranial disease.\n\nIn addition to providing rapid alleviation of neurologic symptoms and enhanced intracranial disease control, WBRT might also prolong the time to develop neurocognitive function (NCF) decline. However, paradoxically NCF decline can also occur due to a sequel of WBRT. In terms of the time course of WBRT-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline occurs within the first 1 - 4 months after WBRT for brain metastases. The domains of early neurocognitive decline principally involve verbal and short-term memory recall.\n\nSince several decades ago, it has been understood that hippocampus plays an essential role in memory function. Not little evidence supports that radiation-induced damage to hippocampus should be strongly associated with NCF impairment. Furthermore, several studies have shown that isodose distribution in hippocampus is closely related to neurocognitive function in patients with benign or low-grade brain tumors. As a consequence, it is hypothesized that conformal hippocampal sparing during the course of WBRT (HS-WBRT) might provide significant preservation in terms of cognitive function.\n\nThis prospective cohort study aims to explore and evaluate the impact of the delivery of HS-WBRT on the pattern of NCF change and the extent of NCF decline in patients receiving prophylactic or therapeutic WBRT. As compared with previous related and relevant studies, it will also be investigated whether neurocognitive functional preservation can be achieved via the integration of hippocampal sparing with the course of WBRT.",[26,197],[387,388,389,390],"Whole Brain Radiotherapy (WBRT)","Neurocognitive Functions (NCFs)","Hippocampus","Hippocampus Sparing during Whole Brain Radiotherapy (HS-WBRT)","2023-04-27",{"date":393,"type":33},"2023-05-01",{"date":395,"type":33},"2013-01-18",{"date":397,"type":20},"2028-12-31",{"name":399,"class":40},"Chang Gung Memorial Hospital",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":291,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":41},"100243565","phase-2-hippocampal-sparing-prophylactic-cranial-irradiation-in-pathologically-nodal-positive-non-small-cell-lung-cancer-100243565","NCT02448992","Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer","Neuropsychological and Oncological Outcomes After Hippocampal-Sparing Prophylactic Cranial Irradiation in Postoperative Patients With Pathologically Nodal Positive Non-Small-Cell Lung Cancer - A Prospective Follow-up Study","Inclusion Criteria:\n\n* Clinical diagnosis of NSCLC\n* Must be adult patients (≥ 18 years old) who have received definitive surgery and have a permanent pathology of nodal metastasis\n* Platinum-based chemotherapy is mandatory\n* Good performance status better than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky (KPS) \\> 70 %\n* Should have sufficient proficiency in Mandarin language\n\nExclusion Criteria:\n\n* Have received prior cranial irradiation\n* Presence of other active primary cancer (exception of basal cell carcinoma of skin and cervical carcinoma in situ)\n* Radiographic evidence of brain metastasis\u002Fmetastases\n* Clinical evidence of extracranial metastatic disease\n* Hypersensitivity to magnetic resonance (MR) contrast enhancer\n* Serious medical or psychiatric illness",{"count":408,"type":20},90,[82,23],"Background. During the clinical course of patients with locoregionally advanced non-small-cell lung cancer (LA-NSCLC) who have undergone aggressive treatment, brain metastasis (BM) is a frequent seen pattern of disease relapse, which cannot be ignored. It still remains unresolved whether prophylactic cranial irradiation (PCI) via whole brain radiotherapy (WBRT) should be recommended for NSCLC patients with stage III or pathologically nodal positive disease. Actually, PCI would significantly decrease the incidence of BM; however, potential WBRT-related neurocognitive function (NCF) sequelae are indeed a concern, which has made PCI seldom applied in clinical practice. In terms of the time course of WBRT-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involve impairments of episodic memory, which has been significantly associated with functions of the hippocampus. This study thus aims to explore the impact of PCI on the subsequent risk of developing BM and the multi-domain neurobehavioral functions in our eligible patients.\n\nMethods. Potentially eligible subjects are postoperative NSCLC patients with a status of pathologically nodal metastasis (pN+). Patients randomly assigned to the PCI arm will undergo the course of hippocampal-sparing PCI after they complete the fourth course of adjuvant platinum-based chemotherapy. Radiotherapy dose will be 3000 cGy in 15 fractions during three weeks. Except for the administration of hippocampal-sparing PCI, patients assigned to the observation arm should receive the same baseline and follow-up brain imaging examinations and neurocognitive assessments as those in PCI arm. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal \\& non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurobehavioral functions for our registered patients.\n\nExpected results. This randomized controlled study aims to verify that the incidence of BM still can significantly be reduced by hippocampal-sparing PCI; additionally, NCF preservation regarding neurobehavioral assessments might also be achieved by hippocampal-sparing PCI as compared with the observation arm without PCI. No matter what the final results present, it is believed that this randomized controlled trial (RCT) will provide us solid evidence concerning the exact value of hippocampal-sparing PCI in our patient setting.",[412,26],"Non-Small-Cell Lung Cancer (NSCLC)",[414,415,416,389,417],"Neurobehavioral Assessments","Neurocognitive Functions (NCF)","Prophylactic Cranial Irradiation (PCI)","Hippocampal-Sparing PCI",{"date":393,"type":33},{"date":420,"type":33},"2015-08-01",{"date":422,"type":20},"2026-12-31",{"name":399,"class":40}]