[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Affiliated Hospital of Xuzhou Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":614},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,46,74,99,121,154,183,204,229,258,276,299,320,344,365,386,410,432,454,477,504,525,548,565,590],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100645362","phase-2-orelabrutinib-combined-with-standard-immunochemotherapy-with-or-without-autologous-hematopoietic-stem-cell-transplantation-auto-hsct-for-newly-diagnosed-diffuse-large-b-cell-lymphoma-dlbcl-100645362",false,"NCT07680933","Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)","A Prospective, Phase II Clinical Study Protocol of Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n* Signed informed consent;\n\n  * Age 18-80 years at the time of signing informed consent, and willingness to comply with the study protocol procedures;\n\n    * Pathologically confirmed CD20-positive DLBCL;\n\n      ④ IPI score of 2-5;\n\n      ⑤ ECOG performance status of 0-2;\n\n      ⑥ Life expectancy ≥12 months;\n\n      ⑦ Left ventricular ejection fraction (LVEF) ≥50% as assessed by multigated acquisition (MUGA) scan or echocardiography (ECHO);\n      * Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or hypersplenism secondary to splenic involvement attributed to DLBCL as determined by the investigator; transfusion of blood products is permitted), defined as follows:\n\n        1. Hemoglobin ≥90 g\u002FL within 7 days prior to enrollment without packed red blood cell transfusion;\n        2. Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL;\n        3. Platelet count ≥75 × 10⁹\u002FL.\n\n           ⑨ Adequate organ function.\n\n           Exclusion Criteria:\n* Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.;\n\n  * Abnormal laboratory values at screening (unless attributable to lymphoma):\n\n    1. Coagulation function: INR \\> 1.5× the upper limit of normal (ULN); PT and APTT \\> 1.5× ULN;\n    2. Liver function: ALT or AST \\> 2× ULN; ALP and bilirubin \\> 1.5× ULN;\n    3. Renal function: Creatinine \\> 1.5× ULN; creatinine clearance \\\u003C 60 mL\u002Fmin (estimated by the Cockcroft-Gault formula);\n\n       ③ HIV-infected patients;\n\n       ④ For HBsAg-positive patients, HBV DNA must be negative prior to enrollment. In addition, if a patient is HBsAg-negative but HBcAb-positive (regardless of HBsAb status), HBV DNA testing is still required. If the result is positive, antiviral therapy is needed, and HBV DNA must be negative prior to enrollment;\n\n       ⑤ Requiring continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers. Patients who have taken strong or moderate CYP3A inhibitors or CYP3A inducers within 7 days prior to the first dose of study drug (or have not completed at least 5 half-lives since the last dose) are not eligible for enrollment;\n       * Inability to swallow capsules or presence of gastrointestinal conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction;\n\n         * Other concurrent and uncontrolled medical conditions that, in the investigator's opinion, may affect the patient's participation in the study, including patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol.","ALL","18 Years","80 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. Orelabrutinib combined with standard immunochemotherapy with or without autologous hematopoietic stem cell transplantation (auto-HSCT) for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.",[28],"DLBCL - Diffuse Large B Cell Lymphoma",[30,31,32],"Orelabrutinib","DLBCL","auto-HSCT","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2026-03-01",{"date":41,"type":22},"2028-12-31",{"name":43,"class":44},"The Affiliated Hospital of Xuzhou Medical University","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100634932","early-phase-1-an-open-label-single-arm-clinical-study-to-evaluate-the-safety-and-preliminary-efficacy-of-cd20-monoclonal-antibody-combined-with-nk042-cell-injection-in-the-treatment-of-multiple-sclerosis-ms-100634932","NCT07546110","An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined With NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).","Inclusion criteria：\n\n1. Able to understand research requirements, voluntary participation, and can provide written informed consent;\n2. Age ≥18 years and ≤65 years;\n3. Subjects diagnosed with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS, with or without recurrence), or primary progressive multiple sclerosis (PPMS) according to the 2017 revision of McDonald's diagnostic criteria (SPMS diagnostic criteria include an initial relapsing-remitting course, subsequent disease progression with or without incidental relapse, mild remission, and plateau; Progress refers to the continuous deterioration of neurological impairment for at least 6 months);\n4. Subjects in the Screening phase had an EDSS score of ≥2.5 and ≤6.5.\n5. Subjects who weighed ≥ 45 kg and had a body mass index (BMI) of ≥ 18.0 kg\u002Fm2.\n\nExclusion criteria：\n\n1. Subjects with a history of seizures or epilepsy (a history of febrile seizures in childhood was permitted);\n2. Subjects with known clinical relapses (acute or subacute new or exacerbating neurological dysfunction with subsequent complete or partial recovery without fever or infection) within 8 weeks prior to enrollment;\n3. Subjects with a history of neurological disorders other than MS, such as head trauma, cerebrovascular disease, and vascular dementia within 3 months;\n4. Recent history of severe infection (e.g., infectious pneumonia, sepsis) within 4 weeks prior to screening; Infections requiring hospitalization or intravenous antibiotics, antiviral drugs, or antifungal drugs within 4 weeks prior to screening; Or a subject with a chronic bacterial infection (e.g., tuberculosis) determined by the investigator to be unacceptable;\n5. Subjects with severe cognitive impairment, mental illness, other neurodegenerative disorders (such as Parkinson's disease or Alzheimer's disease), the presence of substance abuse or any other condition that would make a subject unsuitable for the study, or subjects the investigator believes may interfere with assessment or study completion;\n6. Subjects with a history of attempted suicide or Grade 4 or 5 suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) within 24 weeks prior to the screening visit, or subjects at risk for suicide as determined by the investigator;\n7. Subjects with a history of unstable or severe heart, lung, tumor, liver, or kidney disease or other conditions of medical significance other than MS that prevented safe participation in the study;\n8. Subjects who received live vaccine within 14 days prior to the screening visit or were scheduled to receive vaccine during the study;\n9. Subjects who were HIV-positive;\n10. Subjects with laboratory abnormalities at the screening visit:\n\n    * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3.0 × upper limit of normal (ULN)\n    * Bilirubin \\> 1.5×ULN；; Unless the subject had a history of Gilbert syndrome (bilirubin \\> 1.5×ULN acceptable if bilirubin was split in two and direct bilirubin \\\u003C 35%)\n    * serum albumin \\\u003C 3.5 g\u002FdL\n    * Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2 (modified diet for patients with renal disease \\[MDRD\\])\n    * other abnormal laboratory values or electrocardiogram (ECG) changes considered clinically significant at the investigator's discretion\n11. Subjects with hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) at the screening visit or 12 weeks prior to the first study intervention. If the serological results are consistent with a resolved infection or vaccination, for example, the presence of HBsAb, it may not exclude potential subjects from the trial;\n12. Subjects tested positive for hepatitis C antibodies at the screening visit or within 12 weeks prior to initiation of study drug administration. Note: Only subjects with positive hepatitis C antibodies due to previous disease remission after a confirmed negative hepatitis C ribonucleic acid (RNA) test were enrolled;\n13. Use of immunomodulatory monoclonal antibodies or study drugs within 3 months or 5 half-lives prior to the Screening Period, whichever is higher;\n14. The subject is known to be allergic to any component of study drug or any other NK cell injection drug;\n15. Subjects who were positive for hepatitis B and C screening tests received live or attenuated vaccines within 6 weeks prior to baseline;\n16. Subjects had MRI contraindications of pacemaker implantation, metal implants in high-risk areas (e.g., prosthetic heart valves, aneurysms\u002Fvascular clips), metal substances in high-risk areas (e.g., shrapnel), a known history of gadolinium allergy, or claustrophobia that would prevent completion of all MRI scans as defined in the protocol.\n\n    Note: Patients with contraindication to gadolinium may be included in the study, but gadolinium developer shall not be used for MRI scanning;\n17. Current or past medical history of primary immunodeficiency;\n18. Subjects who were pregnant or lactating, or who were scheduled to become pregnant with severe psychiatric disorders during the study or within 12 months after the last dose, and were not eligible for follow-up;\n19. Other circumstances that the investigator did not consider appropriate for participation in this study;\n20. Subjects currently on any of the following drugs\u002Ftreatments: aminopyridine\u002Fdavapyridine, fingolimod, cladribine, cilimod, ponesimod, ozanimod, alemtuzumab, mitoxantrone, ocrelizumab, natalizumab, or similar approved but different trade names for MS, and any unapproved treatment or regimen for MS. Any new DMT approved after July 2022 and marketed at any time during the study.","65 Years",{"count":54,"type":22},20,[56],"EARLY_PHASE1","This is an Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined with NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).",[59],"Multiple Sclerosis",[59,61,62,63,64],"NK cell therapy","CD20 monoclonal antibody","Cell immunotherapy","Multiple sclerosis (MS)、NK cell therapy、CD20 monoclo、Cell immunotherapynal antibody、","NOT_YET_RECRUITING","2026-04-20",{"date":68,"type":37},"2026-04-22",{"date":70,"type":22},"2026-05",{"date":72,"type":22},"2028-12-30",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100624761","efficacy-and-safety-of-hn2302-in-refractory-myasthenia-gravismg-100624761","NCT07413835","Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)","A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HN2302 in Patients With Refractory Myasthenia Gravis","Inclusion Criteria:\n\n* Age: 18-80 years, no gender restriction;\n* Confirmed diagnosis of generalized myasthenia gravis (MG) with positive AchR or MuSK antibodies, meeting at least one of the following conditions：(1) Repetitive nerve stimulation suggesting neuromuscular transmission defect; (2) Positive response to neostigmine test; (3) Clinically judged improvement of --MG symptoms after oral cholinesterase inhibitor therapy;\n* Clinical classification of MG according to MGFA types IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa, IVb);\n* Baseline MG-ADL score ≥6, ocular-related score \\\u003C50%;\n* Poor response and\u002For lack of efficacy under standard therapies;\n* Minimum life expectancy \\> 12 weeks;\n* Adequate bone marrow, coagulation, cardiopulmonary, liver, and renal function.\n\nExclusion Criteria:\n\n* Subjects positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA, positive for hepatitis C antibody (HCV Ab) with detectable or quantifiable HCV RNA, positive for HIV antibody, positive CMV DNA, or CMV DNA above the lower limit of detection; positive for syphilis antigen or antibody;\n* Presence of other uncontrolled active infections;\n* History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation;\n* Pregnant or breastfeeding women;\n* Receipt of any mRNA-LNP products or other LNP-based drugs within the past two years;\n* History of any of the following cardiovascular conditions within 6 months prior to screening: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease;\n* History of ≥Grade 2 bleeding events within 30 days prior to screening, or requiring long-term continuous anticoagulation therapy (e.g., warfarin, low molecular weight heparin, Xa factor inhibitors);\n* History of live vaccination within 30 days prior to screening;\n* Severe central nervous system diseases or pathological changes, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures\u002Fconvulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychosis;\n* History of asthma or severe allergies;\n* Any condition that, in the investigator's opinion, may increase the patient's risk or interfere with study assessments.",{"count":82,"type":22},6,[84],"NA","This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.",[87],"Refractory Myasthenia Gravis",[89,90],"MG","HN2302","2026-03-16",{"date":93,"type":37},"2026-03-18",{"date":95,"type":37},"2026-03-17",{"date":97,"type":22},"2027-12",{"name":43,"class":44},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":45},"100614884","phase-1-at1019-plus-sbrt-and-pd-1-inhibitor-for-advanced-solid-tumors-an-iit-study-100614884","NCT07285395","AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study","A Phase I Investigator-Initiated Trial (IIT) of AT1019 Combined With Stereotactic Body Radiation Therapy (SBRT) and PD-1 Inhibitor for Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female patients aged ≥ 18 years.\n2. Signed the informed consent form and have the psychological capacity to understand it.\n3. Patients with advanced solid malignant tumors (such as non-small cell lung cancer, renal cell carcinoma, head and neck cancer, cervical cancer, and urothelial carcinoma) who are receiving immunotherapy and planned to undergo SBRT. Patients are eligible if they achieved at least stable disease during previous immunotherapy.\n4. Patients' disease must be evaluated according to RECIST v.1.1.\n5. Presence of metastatic lesions amenable to radiation therapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.\n7. No evidence of clinically significant conduction abnormalities or active ischemia on electrocardiogram (ECG), as judged by the investigator.\n8. Acceptable organ and bone marrow function as demonstrated by the following criteria:\n\n(1) Absolute neutrophil count \\> 1500 cells\u002FμL; (2) Platelet count \\> 50,000 cells\u002FμL; (3) Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); (4) Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 2.5 times the ULN; if hepatic metastasis exists, AST\u002FALT \\\u003C 5 times the ULN; (5) Serum creatinine \\\u003C 1.5 mg\u002FdL and creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault formula; (6) Prothrombin time (PT)\u002Fpartial thromboplastin time (PTT) ≤ 1.5 times the ULN.\n\n9\\. Females of childbearing potential (defined as those who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or are not postmenopausal (defined as at least 12 months of amenorrhea with appropriate clinical documentation, such as age \\> 45 years)) must undergo a serum pregnancy test prior to the first administration of study treatment and confirm a negative result.\n\n10\\. Male and female patients of childbearing potential must agree to use two effective contraceptive methods throughout the study period.\n\nExclusion Criteria:\n\n1. Previous therapeutic radiotherapy to the same lesion.\n2. Failure to recover to grade 1 or lower from clinically significant adverse events related to prior anticancer therapy, as judged by the investigator.\n3. Previous grade 4 toxicity attributed to immunotherapy.\n4. Known untreated brain metastases or treated but unstabilized brain metastases (central nervous system lesions shown on scan to be non-progressive and not requiring corticosteroid use) ≥ 4 weeks prior to enrollment.\n5. QT\u002FQTc interval prolongation (QTc interval \\> 470 milliseconds).\n6. Uncontrolled intercurrent illnesses (including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric\u002Fsocial conditions) that, in the investigator's judgment, would limit the patient's compliance with study requirements.\n7. Pregnant or lactating women.\n8. The Sponsor reserves the right to exclude any patient based on pre-study medical history, physical examination findings, clinical laboratory results, prior medications, or other enrollment criteria.",{"count":107,"type":22},12,[109],"PHASE1","The goal of this clinical trial is to assess the safety and tolerability of AT1019 when used in combination with SBRT and PD-1 inhibitor, and determine the maximum tolerated dose (MTD) of AT1019 in the combination therapy of SBRT and PD-1 inhibitor in patients with advanced solid tumors. The main questions it aims to answer are:\n\nIs the combination of AT1019, SBRT and PD-1 inhibitor safe and well-tolerated in patients with advanced solid tumors? What is the maximum tolerated dose (MTD) of AT1019 when combined with SBRT and PD-1 targeted immunotherapy?\n\nParticipants will:\n\n* First receive PD-1 inhibitor treatment as scheduled.\n* Undergo SBRT, which will be given in 3 to 5 fractions, with each fraction ranging from 6Gy to 18Gy, and the treatment will be administered once a week.\n* Receive intratumoral injection of AT1019 within 1 to 2 days after each SBRT session.\n* Undergo imaging examinations every 6 weeks (with a tolerance of ±1 week) to evaluate the treatment effect.",[112],"Advanced Solid Tumors","2025-12-02",{"date":115,"type":37},"2025-12-16",{"date":117,"type":37},"2025-11-12",{"date":119,"type":22},"2027-12-31",{"name":43,"class":44},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100568584","phase-4-effectiveness-of-proprotein-convertase-subtilisinkexin-type-9-pcsk9-inhibitor-initiation-before-percutaneous-coronary-intervention-on-acute-myocardial-infarction-patients-100568584","NCT06683131","Effectiveness of Proprotein Convertase Subtilisin\u002FKexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients","IMpact of PCSK9 inhibitoR initiatiOn Before Percutaneous Coronary Intervention on Coronary microVascular Dysfunction and Events for Acute Myocardial Infarction: a Multi-center, Open-label, Randomized, Controlled Trial","IMPROVE-AMI","Inclusion Criteria:\n\n* Adults 18-75 years old\n* AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)\n\n  * The requirement for STEMI was that primary PCI was scheduled within 12 hours of onset.\n  * The requirement for NSTEMI was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants .\n* Regardless of baseline LDL-C levels\n* Participants voluntarily took part in this study and signed informed consent\n\nExclusion Criteria:\n\n* Previous or ongoing treatment for any PCSK9i\n* Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial\n* History of hemorrhagic cerebrovascular disease\n* History of old myocardial infarction\u002Fchronic heart failure\n* History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG\n* Above Killip level II\n* Prolonged cardiopulmonary resuscitation (\\>20min)\n* Definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall)\n* malignant arrhythmia\n* Severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors\n* Pregnant or lactating women\n* Participate in other clinical trials","75 Years",{"count":131,"type":22},1160,[133],"PHASE4","The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are:\n\n* Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events?\n* Does drug tafolecimab improve the coronary microvascular dysfunction?\n* What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI.\n\nParticipants will:\n\n* Administer drug tafolecimab by injection or not every month for 12 months\n* Receive the standard of care of AMI\n* Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI\n* Complete cardiac magnetic resonance after PCI if available\n* Visit the clinic at 1,6,12 months after the first administration for checkups and tests\n* Report any discomfort, event or queries at any time",[136],"Acute Myocardial Infarction (AMI)",[138,139,140,141,142,143,144],"Acute Myocardial Infarction","tafolecimab","PCSK9","Coronary Microvascular Dysfunction","Major adverse cardiovascular events","monoclonal antibody against proprotein convertase subtilisin\u002Fkexin type 9","LDL-C","2025-11-18",{"date":147,"type":37},"2025-11-21",{"date":149,"type":22},"2025-11-20",{"date":151,"type":22},"2027-11-30",{"name":43,"class":44},13,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":45},"100535791","association-of-gene-polymorphism-with-susceptibility-to-t2dm-and-the-therapeutic-responses-to-exenatide-in-chinese-patients-with-t2dm-100535791","NCT06256419","Association of Gene Polymorphism With Susceptibility to T2DM and the Therapeutic Responses to Exenatide in Chinese Patients With T2DM","Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University","Inclusion Criteria:\n\n1. a diagnosis of T2DM\n2. a body mass index (BMI) of 20-35 kg\u002Fm2\n3. an HbA1c of 7.0%-12%, an age of 25-70 years\n4. required data available at baseline and 6 months after GLP-1RA therapy.\n\nExclusion Criteria:\n\n1. Patients with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, kidney or liver diseases, severe gastrointestinal dysfunction, and history of pancreatitis\n2. patients receiving GLP-1 analogues, weight loss drugs, glucocorticoids, drugs affecting gastrointestinal peristalsis in the past 3 months\n3. those with missing data at the time points of baseline, 3 months, and 6 months after GLP-1 RA therapy.","25 Years","70 Years",{"count":164,"type":22},300,[84],"This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months. The objective of this study is to investigate the influence of T2DM susceptibility gene polymorphisms (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) on the efficacy of GLP-1 RA (exenatide, liraglutide, etc.), to identify the variables that can predict the efficacy of GLP-1 RA, and to evaluate the weight of these variables on the efficacy.",[168,169],"Type 2 Diabetes Mellitus","Susceptibility, Genetic",[168,171,172,173,174],"GLP-1 RA","gene polymorphism","susceptibility gene","variation","2025-09-17",{"date":177,"type":37},"2025-09-18",{"date":179,"type":37},"2024-01-01",{"date":181,"type":22},"2028-01-31",{"name":43,"class":44},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":45},"100605883","phase-2-tislelizumab--cyclophosphamide-mitoxantrone-liposomes-chidamide-and-prednisone-in-the-treatment-of-new-diagnosed-aitl-100605883","NCT07168317","Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL","Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL: a Multicenter, Single-arm, Prospective Clinical Study","Inclusion Criteria:\n\n* Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length\\>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length\\>1.0cm;\n\n  * Never received systemic or local treatment including chemotherapy before;\n  * Age ≥18 years old, male or female, ECOGPS≤3 points;\n  * Life expectancy exceeds 3 months;\n  * Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria are not eligible for inclusion in this study:\n\n  * Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and\u002For alanine aminotransferase, aspartate aminotransferase and serum creatinine\\>2 times normal values, unless abnormal liver and kidney function is considered to be related to lymphoma;\n  * Bone marrow failure, specifically defined as absolute neutrophil count (ANC)\\\u003C1.5\\*10\\^9\u002FL or platelets \\\u003C75\\*10\\^9\u002FL or Hb\\\u003C90g\u002FL, unless changes in hemogram are considered to be associated with lymphoma infiltration of the bone marrow;\n  * Patients who have previously received local or systemic anti-tumor treatment;\n  * Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction \\\u003C50%; or patients with the following cardiac diseases within 6 months: acute coronary syndrome; acute heart failure (Class III or IV of cardiac function class); patients with a history of clinically significant QT prolongation (\\>450 ms for men,\\>470 ms for women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, symptomatic coronary heart disease requiring medical treatment;\n  * AIDS, syphilis, active B (HBV DNA\\>1\\*10\\^4 copies\u002Fml) and hepatitis C;\n  * Patients with other malignancies that are not effectively controlled; or with other hematological disorders (e.g. hemophilia, myelofibrosis, etc.), the investigator considers that the patient is not suitable for enrollment;\n  * History of autoimmune disease, receiving immunosuppressive therapy before enrollment, immunosuppressive dose\\>10 mg\u002Fday or oral prednisone for more than 2 weeks;\n  * Clinically uncontrolled active infection (including bacterial, fungal or viral infections), and drug therapy is ineffective;\n  * Patients with uncontrolled hemophagocytic syndrome;\n  * Patients who have received secondary surgery or above within 3 weeks before treatment;\n  * Patients who have participated in clinical trials of other drugs within 30 days before enrollment or are participating in clinical trials of other new drugs;\n  * Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;\n  * Known allergies to investigational drug components;\n  * The investigator considers that the enrollment is not suitable.",{"count":191,"type":22},40,[25],"Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs.",[195],"New Diagnosed Angioimmunoblastic T-Cell Lymphoma","2025-09-04",{"date":198,"type":37},"2025-09-11",{"date":200,"type":37},"2025-08-01",{"date":202,"type":22},"2028-08-01",{"name":43,"class":44},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":211,"targetDuration":213,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":45},"100603601","high-frequency-qrs-for-predicting-microvascular-dysfunction-and-adverse-events-after-pci-in-acute-myocardial-infarction-100603601","NCT07138638","High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction","High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction: A Prospective, Multicenter Cohort Study","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive)\n\nDiagnosed with acute myocardial infarction (AMI, including STEMI and NSTEMI) and underwent successful emergency PCI\n\nVoluntarily participated and provided written informed consent\n\nExclusion Criteria:\n\n* History of prior myocardial infarction or chronic heart failure\n\nQRS duration \\>120 ms (including paced rhythm, WPW syndrome, bundle branch block, or left ventricular hypertrophy with repolarization abnormalities)\n\nStructural heart disease (congenital heart disease, cardiomyopathy, aortic dissection, etc.)\n\nPersistent atrial fibrillation or malignant arrhythmias\n\nHistory of cerebral hemorrhage or ischemic stroke within 1 month\n\nProlonged cardiopulmonary resuscitation or requiring advanced life support (IABP\u002FECMO, etc.)\n\nScheduled for imminent surgery with anticipated inability to complete HF-QRS assessment\n\nOther life-threatening conditions including: Severe hepatic or renal dysfunction;Uncontrolled systemic diseases;Hematologic disorders;Active infections;Malignancy with life expectancy \\\u003C1 year Other investigator-determined exclusionary conditions:Pregnancy;Concurrent participation in other clinical trials\n\nRefusal to participate in the clinical study",{"count":212,"type":22},1112,"1 Year","OBSERVATIONAL","This observational study aimed to investigate the prognostic value of high-frequency QRS (HF-QRS) in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI), as well as its potential role in diagnosing microvascular dysfunction. The main question it aims to answer is:\n\n1. Whether HF-QRS could serve as an effective tool for early identification of high-risk AMI patients and prognosis prediction;\n2. Whether HF-QRS provides auxiliary diagnostic value for post-AMI microvascular dysfunction.\n\nParticipants underwent HF-QRS assessment and were prospectively followed for 1 year to record the incidence of major adverse cardiovascular events (MACE).",[217],"AMI",[138,219,220,221],"High-Frequency QRS","prediction model","Microvascular Dysfunction","2025-08-16",{"date":224,"type":37},"2025-08-24",{"date":226,"type":22},"2025-08",{"date":97,"type":22},{"name":43,"class":44},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":236,"maxAge":129,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":247,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":4},"100603226","phase-1-application-of-pd-1-inhibitors-tenofovir-chidamide-and-lenalidomide-in-relapsedrefractory-ebv-associated-lymphoproliferative-disorders-100603226","NCT07133763","Application of PD-1 Inhibitors, Tenofovir, Chidamide, and Lenalidomide in Relapsed\u002FRefractory EBV-associated Lymphoproliferative Disorders.","A Multicenter, Single-Arm, Prospective Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of Relapsed or Refractory EBV-Associated Lymphoproliferative Disorders.","Inclusion Criteria:\n\n1. Histologically confirmed EBV-associated lymphoproliferative disorders, including EBV-positive B-cell LPD and EBV-positive T\u002FNK-cell LPD, with EBV-encoded RNA (EBER)+ by in situ hybridization, or EBV nuclear antigen (EBNA)+, or latent membrane protein (LMP1\u002F2)+ in the lesion tissue.\n2. Age ≤75 years with an ECOG performance status ≤2.\n3. At least one bidimensionally measurable lesion for evaluation: for nodal lesions, longest diameter ≥1.5 cm and shortest diameter ≥1.0 cm; for extranodal lesions, longest diameter ≥1.0 cm; or ≥20% monoclonal EBV-infected lymphocytes detected by flow cytometry.\n4. Expected survival of more than 3 months.\n5. Ability to comply with follow-up. Patients must be aware of the nature of their disease and voluntarily agree to participate in the study and follow-up.\n\nExclusion Criteria:\n\n1. Patients with impaired liver or kidney function, defined as serum direct bilirubin, indirect bilirubin, and\u002For ALT, AST, or serum creatinine levels \\>2 times the upper limit of normal, unless deemed lymphoma-related.\n2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL or platelets \\\u003C75×10⁹\u002FL, unless the hematologic abnormalities are considered due to bone marrow infiltration by lymphoma.\n3. Patients who have experienced grade ≥3 neurotoxicity within the past 2 weeks.\n4. Patients with chronic heart failure classified as NYHA Class III or IV, or with left ventricular ejection fraction \\\u003C50%, or with a history within the past 6 months of any of the following: acute coronary syndrome, acute heart failure (Class III or IV), or significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, or post-resuscitation sudden cardiac arrest).\n5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \\>1×10⁴ copies\u002Fml) or active hepatitis C infection.\n6. Patients diagnosed with malignancies other than lymphoma or currently undergoing treatment for other cancers, except:\n\n   ① Those who have received curative treatment and have been disease-free for ≥5 years prior to enrollment;\n\n   ② Patients with adequately treated, non-melanoma skin cancers such as basal cell carcinoma without evidence of disease;\n\n   ③ Patients with adequately treated carcinoma in situ of the cervix without evidence of disease.\n7. Patients with other hematologic diseases (e.g., hemophilia, myelofibrosis) considered unsuitable for the study by the investigator.\n8. Patients with severe active infections.\n9. Patients who underwent Grade 2 or higher surgery within 3 weeks before treatment initiation.\n10. Patients with a history of substance abuse, or medical, psychological, or social conditions that may interfere with study participation or evaluation, as judged by the investigator.\n11. Any other condition the investigator considers unsuitable for study enrollment.\n12. Known hypersensitivity to any component of the investigational drugs.","0 Years",{"count":238,"type":22},50,[109,25],"This study is a prospective, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in the treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disorders (LPDs). The primary endpoint is the overall response rate (ORR) at 3 months, including complete response (CR) and partial response (PR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), as well as safety and tolerability assessments. Eligible patients must have histologically confirmed EBV-positive B-cell or T\u002FNK-cell LPDs with measurable lesions. This combination regimen targets multiple mechanisms, including inhibition of EBV replication, activation of the immune system, and enhancement of antitumor effects, aiming to provide an innovative therapeutic strategy for this challenging disease.",[242,243,244,245,246],"EBV-Associated Lymphoproliferative Disorders","PD-1 Inhibitor","Tenofovir","Chidamide","Lenalidomide",[242,243,248,245,249],"tenofovir","lenalidomide","2025-08-14",{"date":252,"type":37},"2025-08-21",{"date":254,"type":22},"2025-09-01",{"date":256,"type":22},"2027-09-01",{"name":43,"class":44},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":236,"maxAge":129,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":275,"locationsCount":4},"100603227","phase-1-application-of-pd-1-inhibitors-combined-with-tenofovir-chidamide-and-lenalidomide-in-the-treatment-of-ebv-associated-diseases-100603227","NCT07133776","Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.","A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases","Inclusion Criteria:\n\n1. Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;\n2. EBV DNA ≥ 10⁴ copies\u002FmL in whole blood or plasma;\n3. Age ≤ 75 years with ECOG performance status ≤ 2;\n4. Estimated life expectancy over 3 months;\n5. Patients must be able to undergo follow-up. They should understand the nature of their disease and voluntarily agree to participate in this study for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Patients with impaired liver or kidney function, specifically defined as serum direct bilirubin, indirect bilirubin, and\u002For ALT, AST, or serum creatinine \\>2 times the upper limit of normal (ULN), unless such abnormalities are attributed to lymphoma;\n2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL or platelets \\\u003C75×10⁹\u002FL;\n3. Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;\n4. Patients with chronic heart failure classified as NYHA class III or IV, or left ventricular ejection fraction (LVEF) \\\u003C50%, or those with a history of the following cardiac events within the past 6 months: acute coronary syndrome, acute heart failure (NYHA class III or IV), or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or resuscitated sudden cardiac arrest);\n5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \\>1×10⁴ copies\u002FmL) or hepatitis C infection;\n6. Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;\n7. Patients with severe concurrent infections;\n8. Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;\n9. Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;\n10. Patients deemed unsuitable for enrollment by the investigator;\n11. Patients with known hypersensitivity to components of the investigational drug.",{"count":21,"type":22},[109,25],"Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.",[269,243,244,245,246],"Epstein-Barr Virus (EBV) Infection",[271,243,248,245,249],"Epstein-Barr Virus (EBV) infection",{"date":252,"type":37},{"date":254,"type":22},{"date":256,"type":22},{"name":43,"class":44},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":290,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":296,"leadSponsor":298,"locationsCount":45},"100602217","anti-cd19-car-t-combined-with-btki-to-treat-newly-diagnosed-high-risk-cllsll-100602217","NCT07120633","Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL\u002FSLL","The Efficacy of AntiCD19 CAR-T Combined With BTKi in the Treatment of Newly Diagnosed High-risk CLL Patients, and to Explore Its Efficacy and Safety of Limited-term Treatment in These Patients","Inclusion Criteria:\n\n1. The patient voluntarily participates and signs the informed consent form;\n2. Age ≥18 years old;\n3. Confirmed as CLL\u002FSLL according to WHO standards, and confirmed positive expression of CD19 through flow cytometry or immunohistochemical detection;\n4. Subjects:\n\n   4.1 First-time patients who have not received systemic radiotherapy or chemotherapy in the past. (Except for the following situations: Short-term systemic corticosteroids for disease control, improvement of performance status or treatment of non-cancer indications (use for ≤14 days, prednisone \\\u003C100 mg\u002Fd or dexamethasone ≤20 mg\u002Fd). Steroids must be discontinued before the study of treatment. Inhaled steroids, topical steroids and alternative corticosteroids are permitted for the treatment of asthma.\n\n   4.2 Meet the treatment indications of iwCLL 2018, including: Progressive bone marrow failure caused by bone marrow infiltration due to CLL (hemoglobin \\\u003C10 g\u002FL and platelet count \\\u003C100×10⁹\u002FL); 4.3 Patients with high-risk genetic molecular factors (del(17p), TP53 gene deletion\u002Fmutation (vaf\\>10%), U-IGHV, complex karyotype); 4.4 Have measurable or evaluable lesions (positive peripheral blood flow results or lesions ≥1cm evaluated based on PET-CT\u002FCT\u002FMRI).\n\n   4.5 No contraindications for treatment with Bruton's tyrosine kinase (BTK) inhibitors or BCL2 inhibitors.\n5. Good functions of major tissues and organs:\n\n   5.1 Liver function: ALT\u002FAST\\\u003C3 times the upper limit of the normal value and total bilirubin ≤34.2 μmol\u002FL; 5.2 Renal function: Creatinine \\\u003C 220 μmol\u002FL; 5.3 Pulmonary function: Indoor oxygen saturation ≥95%; 5.4 Cardiac function: Left ventricular ejection fraction ≥40%.\n6. The peripheral superficial veins have smooth blood circulation and can accept intravenous infusion.\n7. ECOG score ≤2;\n8. The expected survival period is more than three months.\n\nExclusion Criteria:\n\n1. CLL patients who have undergone Richter transformation;\n2. Patients known to have active malignant tumors involving the central nervous system. For patients who have previously suffered from central nervous system diseases and have received effective treatment, if they have completed treatment for at least 3 months before enrollment, have no evidence of symptomatic diseases, and the imaging examination shows abnormal stability, they will be considered for enrollment.\n3. There is a history of primary malignant tumor, and it has not been relieved for at least two years. The following situations are not subject to the two-year limit: non-melanoma skin cancer, completely resected stage 1 solid tumors with low recurrence risk, radical treatment of local prostate cancer, biopsion-revealed cervical cancer in situ or smear-revealed squamous intraepithelial lesions, and completely resected breast cancer in situ.\n4. Active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus infection;\n5. There was an uncontrollable systemic fungal, bacterial or viral infection within 4 weeks before enrollment;\n6. Have a history of any of the following cardiovascular diseases within the past 6 months: grade III or IV heart failure as defined by the New York Heart Association, angioplasty or stent implantation, myocardial infarction, unstable angina pectoris, clinically obvious arrhythmia, or other clinically significant heart diseases;\n7. Women who are pregnant (with a positive urine\u002Fblood pregnancy test) or breastfeeding;\n8. Patients who are allergic to large molecule biological drugs such as antibodies or cytokines;\n9. Had systemic hormones or immunosuppressive drugs been used within 4 weeks before enrollment (except for patients with inhaled hormones);\n10. Suffer from mental illness;\n11. The researcher determined that the patient had other conditions that made him unsuitable for inclusion in the group.",{"count":238,"type":22},[84],"At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of newly diagnosed high-risk patients, thereby improving the long-term prognosis of high-risk CLL patients and reducing the long-term medication rate of CLL patients, providing more treatment options and hope for newly diagnosed high-risk CLL patients.",[287,288,289],"CLL","CAR-T Cell Therapy","SLL",[291,287,289],"CAR-T","2025-08-12",{"date":294,"type":37},"2025-08-13",{"date":254,"type":22},{"date":297,"type":22},"2028-09-01",{"name":43,"class":44},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":45},"100597408","phase-2-tislelizumab--cyclophosphamide-mitoxantrone-liposomes-chidamide-and-prednisone-in-the-treatment-of-rr-aitl-100597408","NCT07058103","Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of R\u002FR AITL","Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of R\u002FR AITL: a Multicenter, Single-arm, Prospective Clinical Study","Inclusion Criteria:\n\n* Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length\\>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length\\>1.0cm;\n* Refractory or relapsed after at least one systemic therapy (including chemotherapy, stem cell transplantation)\\*;\n* Age ≥18 years old, male or female, ECOGPS≤3 points;\n* Life expectancy exceeds 3 months;\n* Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up.\n\n  * : Relapse: patients achieve complete response (CR) or partial response (PR), disease progression (PD) ≥6 months; refractory: treatment failure (no PR) or PD \\\u003C6 months after the last chemotherapy.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are not eligible for inclusion in this study:\n\n* Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and\u002For alanine aminotransferase, aspartate aminotransferase and serum creatinine\\>2 times normal values, unless abnormal liver and kidney function is considered to be related to lymphoma;\n* Bone marrow failure, specifically defined as absolute neutrophil count (ANC)\\\u003C1.5\\*10\\^9\u002FL or platelets \\\u003C75\\*10\\^9\u002FL or Hb\\\u003C90g\u002FL, unless changes in hemogram are considered to be associated with lymphoma infiltration of the bone marrow;\n* The subject's prior history of antineoplastic therapy meets one of the following conditions: (1) prior mitoxantrone or mitoxantrone liposome therapy;(2) prior PD-1 or PD-L1 inhibitor therapy;(3) Angioimmunoblastic T-cell lymphoma previously treated with histone deacetylase inhibitors;\n* Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction \\\u003C50%; or patients with the following cardiac diseases within 6 months: acute coronary syndrome; acute heart failure (Class III or IV of cardiac function class); patients with a history of clinically significant QT prolongation (\\>450 ms for men,\\>470 ms for women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, symptomatic coronary heart disease requiring medical treatment;\n* AIDS, syphilis, active B (HBV DNA\\>1\\*10\\^4 copies\u002Fml) and hepatitis C;\n* Patients with other malignancies that are not effectively controlled; or with other hematological disorders (e.g. hemophilia, myelofibrosis, etc.), the investigator considers that the patient is not suitable for enrollment;\n* History of autoimmune disease, receiving immunosuppressive therapy before enrollment, immunosuppressive dose\\>10 mg\u002Fday or oral prednisone for more than 2 weeks;\n* Clinically uncontrolled active infection (including bacterial, fungal or viral infections), and drug therapy is ineffective;\n* Patients with uncontrolled hemophagocytic syndrome;\n* Patients who have received secondary surgery or above within 3 weeks before treatment;\n* Patients who have participated in clinical trials of other drugs within 30 days before enrollment or are participating in clinical trials of other new drugs;\n* Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;\n* Known allergies to investigational drug components;\n* The investigator considers that the enrollment is not suitable.",{"count":191,"type":22},[25],"Angioimmunoblastic T cell lymphoma (AITL) is a rare and aggressive lymphoma. Some patients relapsed after initial treatment or did not respond to standard treatment (refractory). Subsequent treatment options are limited and the efficacy is not ideal. This study attempts to explore the possibility of improving the efficacy of immunotherapy combined with chemotherapy and epigenetic regulatory drugs.",[310,311],"Angioimmunoblastic T-Cell Lymphoma Recurrent","Angioimmunoblastic T-Cell Lymphoma Refractory","2025-07-09",{"date":314,"type":37},"2025-07-10",{"date":316,"type":37},"2025-04-01",{"date":318,"type":22},"2028-04-01",{"name":43,"class":44},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":343,"locationsCount":45},"100595615","phase-ii-clinical-study-on-the-safety-and-efficacy-of-combined-car-t-therapy-following-autologous-stem-cell-transplantation-in-multiple-myeloma-100595615","NCT07034755","Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma","Inclusion Criteria:\n\n* Age: 18-70 years old\n* Expected survival: \\>12 weeks\n* Diagnosis: Multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies\n* Post-chemotherapy status:\n* Patients who achieved partial response (PR) or better but failed to reach complete response (CR) after four cycles of first-line chemotherapy Patients who achieved CR after four cycles of first-line chemotherapy but have high-risk factors\n* Liver function:\n\n  * ALT and AST \\\u003C 3 times the upper limit of normal\n  * Bilirubin \\\u003C 2.0 mg\u002Fdl\n* Performance status: Karnofsky Performance Status (KPS) \\>50%\n* Organ function: No severe liver, kidney, or heart diseases\n* Stem cell transplantation: Eligible for stem cell transplantation\n* Venous access: Able to undergo venous blood sampling without contraindications to leukapheresis\n* Informed consent: Capable of understanding and voluntarily signing a written informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or lactation, or women planning pregnancy within the next 6 months\n* Infectious diseases(e.g., HIV, active tuberculosis)\n* Active hepatitis B or C infection\n* Feasibility assessment showing lymphocyte-targeted transfection rate \\\u003C10% or insufficient expansion (\\\u003C5-fold) under CD3\u002FCD28 co-stimulation\n* Abnormal vital signs or inability to cooperate with examinations\n* Psychiatric\u002Fpsychological disorders precluding treatment compliance or efficacy evaluation\n* Severe allergic constitution or history of severe allergies, especially to IL-2\n* Systemic or localized severe infection requiring anti-infective therapy\n* Severe autoimmune diseases\n* Other conditions deemed unsuitable for inclusion by the investigator",{"count":54,"type":22},[84],"Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy is a rapidly developing novel approach in adoptive immunotherapy for tumors in recent years. Its main characteristic lies in genetically engineering T cells to express tumor antigen-specific receptors, thereby endowing them with targeting capability, cytotoxicity, and persistence. This approach has demonstrated remarkable efficacy in relapsed\u002Frefractory hematologic malignancies. Research on multiple myeloma (MM)-specific CAR-T cells has also been progressively conducted with promising outcomes, establishing CAR-T cell therapy as an effective new treatment strategy for MM. Notably, targets such as B-cell maturation antigen (BCMA) and GPRC5D have emerged as prominent therapeutic targets for CAR-T cell therapy.\n\nTherefore, we propose to evaluate the efficacy and safety of sequential CAR-T therapy following autologous hematopoietic stem cell transplantation (ASCT) in newly diagnosed MM patients who achieve partial response (PR) or better after four cycles of first-line chemotherapy but fail to attain complete response (CR), or those who achieve CR but present with high-risk factors. The clinical data from this study will provide evidence-based support for novel treatment strategies in this subset of MM patients.",[330,331,332],"Multiple Myeloma (MM)","Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","Chimeric Antigen Receptor T-cell",[334,335,336],"Chimeric Antigen Receptor T-Cell","allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","multiple myeloma (MM)","2025-06-29",{"date":339,"type":37},"2025-07-02",{"date":341,"type":22},"2025-07-01",{"date":318,"type":22},{"name":43,"class":44},{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":45},"100589904","a-prospective-study-on-ivus-and-dsa-guidance-in-the-treatment-of-budd-chiari-syndrome-100589904","NCT06960473","A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome","A Prospective Randomized Controlled Clinical Study on Interventional Treatment of Budd-Chiari Syndrome Guided by IVUS and DSA","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Primary Budd-Chiari Syndrome (narrowing or occlusion of the inferior vena cava near the hepatic veins or hepatic vein openings).\n* Presence of membrane or short segment stenosis or occlusion suitable for balloon dilation (≤ 5 cm).\n* Child-Pugh score less than 13.\n* The patient or their authorized family member signs an informed consent form, voluntarily participating in the study and agreeing to follow-up.\n\nExclusion Criteria:\n\n* Prior interventional treatment.\n* Unfit for balloon dilation or stent placement (e.g., diffuse obstruction of the hepatic veins recommended for TIPS treatment, end-stage liver disease recommended for liver transplantation, etc.).\n* Coexisting severe heart disease (such as heart failure, severe arrhythmias), liver or kidney failure, severe infections, iodinated contrast agent allergy.\n* Coexisting hepatocellular carcinoma or other malignant tumors.\n* Pregnant or breastfeeding women.\n* Patients with a life expectancy of less than 1 year.\n* Patients unable to complete follow-up or cooperate with the study.",{"count":352,"type":22},260,[84],"This study aims to evaluate the effectiveness of interventional treatment guided by Intravascular Ultrasound (IVUS) compared to Digital Subtraction Angiography (DSA) in patients with Budd-Chiari Syndrome (BCS). Using a prospective, randomized controlled trial design, patients who meet the diagnostic criteria for BCS and are suitable for interventional treatment are randomly divided into the IVUS group and the DSA group. The IVUS group will undergo detailed assessment of vascular structure before interventional treatment to select the appropriate balloon for dilation, whereas the control group will make decisions based on DSA results. The primary endpoint of the study is the postoperative restenosis rate, while secondary endpoints include complications of interventional treatment, liver function, and patient survival rate. Successful implementation of this study will provide new technical means to optimize interventional treatment strategies for BCS, and help improve treatment outcomes and long-term prognosis for patients.",[356],"Budd-Chiari Syndrome","2025-04-29",{"date":359,"type":37},"2025-05-07",{"date":361,"type":22},"2025-05-18",{"date":363,"type":22},"2026-12-31",{"name":43,"class":44},{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":385,"locationsCount":4},"100589751","phase-2-iparomlimab-and-tuvonralimab-injection-ql1706-combined-with-bevacizumab-for-postoperative-adjuvant-therapy-in-hepatocellular-carcinoma-hcc-with-high-risk-of-recurrence-100589751","NCT06958484","Iparomlimab and Tuvonralimab Injection (QL1706) Combined With Bevacizumab for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma (HCC) With High Risk of Recurrence","Iparomlimab and Tuvonralimab Injection (QL1706) Combined With Bevacizumab for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma (HCC) With High Risk of Recurrence: A Multicenter, Open-Label, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Voluntarily participate in this study and sign the informed consent form;\n2. Age 18-100 years old, male or female;\n3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging;\n4. CNLC PHASE I-II;\n5. After surgical resection or local ablation, the intraoperative pathology shows that there is no residual resection margin, or R0 is confirmed by imaging within 4\\~8 weeks after surgery;\n6. Have at least one high-risk recurrence factor:\n\n(Definition of high-risk recurrence factors: Definition of high-risk recurrence factors: after radical surgery: presence of a single tumor \\>5 cm in diameter; Number of tumors\\>=3; concomitant vascular invasion (microvascular invasion or Vp1-2); Tumor grade III-IV; Post-ablation: 1. Single tumor \\>2cm but \\\u003C= 5cm; 2. Multiple tumors: 2-4, all tumors \\\u003C= 5 cm); 7. ECOG PS score: 0\\~1 points; 8. Child-Pugh Liver Function Rating: Grade A (\\\u003C = 6 points) 9. Expected survival time \\>=12 months; 10. The laboratory test values within 3 days before the first dose meet the following requirements:\n\n1. Routine blood test: (except for hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor \\[G-CSF\\], no correction with medication within 2 weeks prior to screening):\n\n   Absolute neutrophil count \\>=1.5×10\\^9\u002FL; Platelets \\>=75×10\\^9\u002FL; Hemoglobin \\>=90 g\u002FL;\n2. Biochemical examination:\n\n   serum albumin \\>=30g\u002FL; Serum total bilirubin \\\u003C = 1.5×ULN; ALT and AST \\\u003C= 3×ULN; Serum creatinine \\\u003C = 1.5×ULN; or Cr clearance \\>50 mL\u002Fmin\n3. International normalized ratio (INR) \\\u003C = 1.2 or prothrombin time (PT) outside the range of normal controls \\\u003C = 2 seconds;\n4. urine protein \\\u003C2 (if urine protein \\>=2, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification \\\u003C1.0g can be enrolled); 11. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, you need to test for HBV-DNA, and the HBV-DNA needs to be \\\u003C2000 IU\u002FmL (if the site only has a copy\u002FmL testing unit, it must be \\\u003C 104 copy\u002FmL); For subjects with HBV-DNA\\>=2000 IU\u002FmL, at least 1 week of antiviral therapy (only nucleosides such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenol tablets are allowed) prior to the first dose, and the viral copy number decreased by more than 10-fold (1 lg) compared to before the first dose. For patients with HBV infection, antiviral therapy is required throughout the study. Hepatitis C virus (HCV)-RNA positive subjects must be on antiviral therapy as per treatment guidelines; 12. Women of childbearing potential must have a negative pregnancy test (βHCG) before starting the first dose. Women of childbearing potential and men (sexually active with women of childbearing potential) must agree to contraception during treatment and within 6 months of the last dose.\n\nExclusion Criteria:\n\n1. It is known that there are fibrotic plate HCC, sarcomatoid HCC or mixed-type cholangiocarcinoma and HCC;\n2. There is evidence of residual, recurrent or metastatic disease;\n3. History of hepatic encephalopathy;\n4. Previous receipt of allogeneic stem cell or solid organ transplantation, or on the waiting list for liver transplantation;\n5. Any treatment before HCC resection or ablation, including systemic treatment (including experimental drugs) and local treatment, such as TACE; and subjects who received more than one cycle of adjuvant TACE treatment after surgical resection;\n6. Within 5 years before the first medication, there is a history of malignant tumors other than HCC, with negligible risk of metastasis or death (such as 5-year OS rate \\> 90%), such as fully treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer;\n7. Co-infection with HBV and HCV, co-infection with HBV and delta hepatitis virus infection;\n8. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or chest CT scan at screening shows evidence of active pneumonia;\n9. Active tuberculosis;\n10. History of autoimmune diseases or immunodeficiency diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome or multiple sclerosis;\n11. Severe infection within 4 weeks before the first medication, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia;\n12. Received oral or intravenous antibiotic treatment within 2 weeks before the first medication;\n13. Use of non-steroidal anti-inflammatory drugs (NSAIDs) for daily treatment of chronic diseases;\n14. Have bleeding predisposition or significant evidence of coagulation dysfunction (without anticoagulant treatment);\n15. Currently or recently using aspirin or full-dose oral or intravenous anticoagulants;\n16. Hemorrhage events due to untreated or incompletely treated esophageal and\u002For gastric varices within 6 months before the first medication;\n17. Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the first medication;\n18. Inadequate control of arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure \\>= 90 mmHg) (based on the average value of \\>= 2 measurements of BP readings), allowing the above parameters to be achieved through the use of antihypertensive treatment; previous occurrence of hypertensive crisis or hypertensive encephalopathy;\n19. Significant uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL, or corrected serum calcium \\> ULN) within 6 months before the first medication;\n20. Within 3 months of having severe cardiovascular diseases (such as NYHA class II or above heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmias or unstable angina pectoris;\n21. Clinically significant ascites;\n22. Within 6 months before the first medication, having a history of intra-abdominal inflammation, including but not limited to peptic ulcer, diverticulitis or colitis;\n23. Within 6 months before the first medication, having a history of abdominal or tracheoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess;\n24. Severe, non-healing or ruptured wounds, active ulcers or untreated fractures;\n25. Performed hollow needle biopsy or other minor surgeries within 3 days before the first medication, excluding the placement of vascular access devices. 26. Within 4 weeks prior to the first administration of the drug, underwent major surgery, or was expected to undergo major surgery during the study period;\n\n27\\. Had previously used systemic immunostimulants or immune checkpoint blockade therapy; 28. Was expected to receive systemic immunosuppressive drugs (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-α \\[TNF-α\\] preparations) within 2 weeks prior to the first administration of the drug, or was expected to receive systemic immunosuppressive drugs during the study treatment period; 29. Was vaccinated with live vaccines within 30 days prior to the first administration of the drug, or was expected to receive such vaccines during the treatment period or within 5 months after the last administration; 30. Was known to be allergic to any study drug or excipients; 31. Was contraindicated from using the investigational drug, or had any other diseases, metabolic disorders, physical examination findings, or clinical laboratory findings that might affect the interpretation of results or place the patient at a high risk of treatment complications; 32. Had other factors considered by the investigator as unsuitable for participation in the study.",{"count":373,"type":22},60,[25],"Evaluation of the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706) in combination with bevacizumab for postoperative adjuvant treatment of HCC with high-risk recurrence risk",[377,378],"HCC - Hepatocellular Carcinoma","Adjuvant Treatment","2025-04-27",{"date":381,"type":37},"2025-05-06",{"date":383,"type":22},"2025-05-01",{"date":119,"type":22},{"name":43,"class":44},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":399,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":45},"100564729","phase-1-a-clinical-trial-aimed-at-assessing-the-efficacy-and-safety-of-vt-101-for-the-treatment-of-non-muscle-invasive-bladder-cancer-100564729","NCT06632964","A Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer","An Open-label, Single-arm Exploratory Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Age 18-75 years old (including 18 and 75 years old), male or female;\n2. Patients with non-muscle-invasive bladder cancer (NMIBC) confirmed by histopathological examination results (pathological stage: high-grade Ta or any T1 level papillary carcinoma or cystoscopic random biopsy confirmed presence of bladder in situ carcinoma (CIS) (with or without papillary carcinoma): according to the results of the biopsy taken within 8 weeks before the first treatment according to the study. If multiple bladder biopsies are needed to confirm eligibility, the last biopsy must be taken within 8 weeks.\n\n   For patients with high-risk disease at the second TURBT, defined as high-grade Ta\u002FT1 lesions, the subject must completely remove all visible tumors before enrollment and be recorded at the baseline cystoscopy.\n\n   The results of the cellular pathology examination for high-grade urothelial carcinoma must be negative before enrollment, excluding those with unresectable high-risk and extremely high-risk NMIBC in the dose-escalation stage.\n\n   CIS does not require complete removal, but must be completely removed along with papillary carcinoma before enrollment, and be recorded at the baseline cystoscopy. No requirement is made for negative urine cytology results for malignant cells.\n\n   For those with unresectable high-risk and extremely high-risk NMIBC included in the dose-escalation stage, urine cytology results for malignant cells may not be required to be negative before enrollment.\n\n   When the investigator assesses the subject as medically unfit for TURBT or radical cystectomy or the subject refuses TURBT or radical cystectomy after consulting a urologist, the subject may also participate in this study.\n3. Moderate, high risk and very high risk NMIBC; Specific definitions are as follows:\n\n   1. Medium-risk NMIBC:\n\n      ● Does not meet the conditions of low risk, high risk, and very high risk groups, and does not have CIS\n   2. High-risk NMIBC:\n\n      * T1 HG\u002FG3 tumors without CIS and not eligible for the very high risk group\n      * Tumors present CIS and do not meet the conditions of the very high risk group\n      * Ta LG\u002FG2 or TI G1, no CIS, and three clinically relevant risk factors Ta HG\u002FG3 or TI LG, without CIS, and with at least two clinically relevant risk causes plain\n      * TI G2, without CIS and containing at least one clinically relevant risk factor c.very high risk NMIBC:\n      * Ta HG\u002FG3 with CIS and three clinically relevant risk factors ●TI G2 with CIS and at least two clinically relevant risk factors\n      * TIHG\u002FG3, CIS, with at least one clinically relevant risk factor ●TIHG\u002FG3, CIS, with three clinically relevant risk factors\n      * CIS in the prostatic urethra\n      * Urothelial carcinoma with undesirable histological variation subtype\n      * Accompanied by vascular lymphatic invasion\n\n      Note: Clinically relevant risk factors include:\n      1. Age≥ 70 years old;\n      2. Multiple papillary tumors;\n      3. Diameter≥ 3cm. Subtypes of adverse histological variation include: urothelial carcinoma with partial squamous or adenoid or trophoblastic differentiation, micropapillary urothelial carcinoma, nested nested nested variant (including large nested variant), and microcystic variant urothelial carcinoma, plasmacytoid, giant cell, sigma-ring cell, diffuse, undivided Metastatic urothelial carcinoma, lymphoepitheliomatoid carcinoma, small cell carcinoma, sarcomatoid urothelial carcinoma, introneural secretory variant urothelial carcinoma.\n4. The general status score of the American Eastern Oncology Consortium (ECOG) (Appendix 4) was 0 to 1;\n5. Expected survival≥ 2 years;\n6. The subjects have adequate organ and bone marrow function, meeting the following laboratory test criteria (Note: If an individual laboratory test result does not meet the criteria, a repeat screening is allowed):\n\n   Complete blood count: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, white blood cell count (WBC) ≥3.0×109\u002FL, platelet count (PLT) ≥75×109\u002FL, hemoglobin (Hb) ≥90g\u002FL (Note: No blood components, cell growth factors, etc. may be used for interventional treatment within 14 days prior to the test to ensure that the test results meet the above requirements).\n\n   Liver function: Serum total bilirubin (TBIL) ≤ 1.5 x ULN, albumin (ALB) ≥30 g\u002FL; No liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; Liver metastasis, ALT and AST need ≤5.0 x ULN; Kidney function: Serum creatinine (Scr) ≤ 1.5 x ULN, or creatinine clearance rate ≥ 50 mL\u002Fmin (creatinine≥ 1.5 x ULN, creatinine clearance rate will be calculated according to Cockcroft-Gault formula.); Coagulation function: International normalized ratio (INR) ≤1.5 x ULN or prothrombin time (PT) ≤ 1.5 x ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;\n7. The results of blood pregnancy test performed by women of childbearing age within 7 days before treatment were negative. Female participants of reproductive age, as well as male participants whose partners are women of reproductive age, must agree to use at least one medically approved contraceptive method (such as surgical sterilization, oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicide) for the entire study period and for at least 6 months after the last study drug treatment. Fertile women in this program are defined as sexually mature women who have not undergone hysterectomy or bilateral oophorectomy; or spontaneous menopause that has not lasted 24 months (amenorrhea after cancer treatment does not exclude fertility), that is, menstruation at any time in the 24 consecutive months prior to screening);\n8. Male subjects must agree not to donate sperm during treatment and for at least 6 months after the last treatment;\n9. The subjects fully understand and know the whole study process, voluntarily participate in the study, sign the informed consent, and the expected compliance is good.\n10. During the study period, patients must be willing to comply with the study requirements for cystoscopy, urine cytology, urography, biopsy (TURBT or other excision for all Ta\u002FT1 diseases). For these procedures, patients who withdraw their consent will withdraw from the trial.\n\nExclusion Criteria:\n\n1. A current or past history of muscular invasive (T2 or higher stage) or locally advanced (T3\u002FT4, any N) or metastatic bladder cancer;\n2. Urothelial carcinoma of the upper urogenital tract (kidney, renal collecting system, ureter) or prostatic urethra (including urethral CIS) in the 24 months prior to enrollment;\n3. Cystoscopy orimaging examination confirmed the current bladder perforation;\n4. Prior systemic treatment, radiation therapy, or surgery for bladder cancer during screening, in addition to TURBT or bladder biopsy. Intravesical perfusion within 8 weeks prior to initiation of study therapy, with the exception of a single infusion of cytotoxic drugs (e.g. mitomycin C, gemcitabine, pirarubicin, and epirubicin) immediately after TURBT surgery;\n5. Past treatment with oncolytic virus drugs or similar drugs;\n6. Concurrent severe medical conditions, including but not limited to severe heart disease, cerebrovascular disease, uncontrolled diabetes, severe infection, active digestive ulcer, or uncontrolled high blood pressure (defined as systolic\u002Fdiastolic blood pressure ≥150\u002F100 mmHg after treatment with standardized antihypertensive drugs, or one of them); Angina pectoris in the last 3 months; Myocardial infarction or cardiac insufficiency within 1 year prior to enrollment (NYHA rating: Heart function ≥II, see Appendix 2); Severe arrhythmias requiring medical treatment; Left ventricular ejection fraction (LVEF) ≤ 50%; Adjusted for QTc interval (Fridericia formula) ≥ 480 ms, or risk factors present at the tip of torsified ventricular tachycardia, such as clinically significant hypokalemia as determined by the investigator, family history of long QT syndrome, or family history of arrhythmia (such as preexcitation complex);\n7. Patients who are expected to have major surgery during the study period (including the screening period);\n8. The subject has an active infection or unexplained fever≥ 38.5 ℃ during screening or before the first dose;\n9. Subject with congenital or acquired immune deficiency (such as HIV infection), syphilis antibody positive or active hepatitis B: Hepatitis B surface antigen \\[HBsAg\\] and\u002For hepatitis B core antibody \\[HBcAb\\] positive with ≥ 1000 copies of HBV-DNA \\[cps\\]\u002FmL or higher than the upper limit of normal detection; Or test positive for hepatitis C antibodies, and HCV-RNA is higher than the upper limit of normal test values;\n10. Had received any of the following treatments within a specified time frame prior to enrollment: a. Had undergone major surgery (whether or not related to the tumor) within 4 weeks, except for minimally invasive surgery under gastroenteroscopy; b. Within 4 weeks Extended radiotherapy, or local radiotherapy within 2 weeks (investigators can determine the appropriate enrollment time based on the recovery of toxicity after radiotherapy); c. Participating in other therapeutic\u002Finterventional clinical trials within 4 weeks or currently; d. Received any local or systemic anti-tumor therapy (including anti-tumor Chinese medicines and Chinese adult drugs) within 4 weeks or within 5 half-lives of the drug (calculated as a shorter time);\n11. Presence of toxicity from prior antitumor therapy that has not returned to CTCAE 5.0 level 0 or 1 or levels specified in the inclusion or exclusion criteria prior to initial administration (excluding alopecia, skin pigmentation, and non-clinically significant and asymptomatic laboratory abnormalities);\n12. Received immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 2 weeks before the first dose;\n13. Allergic to adenovirus or any component of the test drug;\n14. The subject has a known history of psychotropic substance abuse, alcohol abuse, or drug use;\n15. History of other malignancies within the last 5 years, except cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and cured thyroid carcinoma in situ;\n16. Subjects with an active autoimmune disease or a history of an autoimmune disease that may recur, but subjects with the following conditions are admitted:\n\n    1. Patients with type 1 diabetes whose condition is stable after treatment with stable doses of insulin;\n    2. hypothyroidism (if controlled with hormone replacement therapy alone);\n    3. controlled and stable celiac disease;\n    4. Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia);\n    5. any other disease that will not recur in the absence of an external trigger.\n17. Patients need to use corticosteroids (prednisone≥ 10 mg\u002F day or equivalent dose of the same drug) or any other condition requiring systemic immunosuppressant treatment for 4 weeks prior to initial dosing. However, participants who are currently or have previously used the following steroid regimens may be enrolled:\n\n    1. adrenal substitute steroid (prednisone ≤10 mg\u002F day or equivalent dose of similar drugs);\n    2. Systemic absorption of very small amounts of local, ocular, intra-articular, intranasal or inhaled corticoid solid alcohol.\n18. Pregnant or lactating women, or male and female subjects who planned to have children during the trial period (from screening visit to 6 months after the last dosing). Any pregnancy that occurred during the test Participants need to withdraw from the study;\n19. Persons who need to receive live vaccine within 30 days before the first dose and during the expected study period;\n20. The investigator considers that the subjects have other factors that make them unfit to participate in the study.",{"count":394,"type":22},16,[109],"This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer",[398],"Non-muscle Invasive Bladder Cancer",[400,401],"Oncolytic virus","Non-muscle invasive bladder cancer","2024-10-07",{"date":404,"type":37},"2024-10-09",{"date":406,"type":37},"2024-09-18",{"date":408,"type":22},"2025-10-01",{"name":43,"class":44},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":45},"100563348","establishment-of-an-early-warning-screening-system-for-hemophagocytic-lymphohistiocytosis-a-multi-center-prospective-study-100563348","NCT06614998","Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis a Multi-center, Prospective Study","Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis: a Multi-center, Prospective Study","Inclusion Criteria:\n\nSubjects must meet all of the following criteria:\n\n1. Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step\n2. Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc\n\nExclusion Criteria:\n\nExclusion Criteria Subjects who meet one of the following criteria will not be enrolled: 1. Patients with liver cirrhosis, liver cancer, and hepatic encephalopathy 2. Patients with trauma, hepatosplenic rupture and other organ hemorrhage 3. Patients with severe disease such as shock, sepsis, and multiple organ failure 4. Patients with DIC 5. Patients with long-term anemia 6. Patients with acute promyelocytic leukemia 7. Patients with idiopathic deafness 8. Patients who have taken hormones\u002Fimmunosuppressants 72 hours before admission 9. Hereditary fibrinogen deficiency",{"count":418,"type":22},80,"Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life.",[421],"Hemophagocytic Syndrome",[423],"hemophagocytic syndrome screening system","2024-09-27",{"date":426,"type":37},"2024-10-01",{"date":428,"type":37},"2024-05-01",{"date":430,"type":22},"2026-05-01",{"name":43,"class":44},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":453,"locationsCount":45},"100558013","predictive-role-of-strem-in-endovascular-thrombectomy-outcomes-100558013","NCT06545591","Predictive Role of sTREM in Endovascular Thrombectomy Outcomes","Soluble Soluble Triggering Receptors Expressed on Myeloid Cells (sTREM) Predict Outcomes in Stroke Patients Receiving Endovascular Thrombectomy","Inclusion Criteria:\n\n* Patients \\> 18 years old.\n* Patients with acute large vessel occlusion within 24 hours of onset who will receive endovascular treatment.\n\nExclusion Criteria:\n\n* Impossibility of getting a blood sample.\n* Impossibility of performing the test (Invalid results).\n* Refusal to provide the informed consent by the patient\u002Frelative.",{"count":164,"type":22},"Soluble triggering receptor expressed on myeloid cells (sTREM), which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. This study is to investigatethe prognostic roles of sTREM (sTREM1 and sTREM2) in patients with ischemic stroke who underwent endovascular thrombectomy (EVT).",[442],"Acute Ischemic Stroke",[444,445,446],"Thrombectomy","soluble TREM-1","soluble TREM-2","2024-08-07",{"date":449,"type":37},"2024-08-09",{"date":451,"type":37},"2024-07-01",{"date":119,"type":22},{"name":43,"class":44},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":464,"studyType":214,"phases":4,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":45},"100446815","circulating-circrna-in-acute-ischemic-stroke-100446815","NCT05098340","Circulating circRNA in Acute Ischemic Stroke","Clinical Significance of Circulating circRNA in Acute Ischemic Stroke (CRAST)","CRAST","Inclusion Criteria:\n\n* Aged 18 years or older\n* Confirmed acute ischemic stroke by a diffusion-weighted imaging-position lesion on magnetic resonance imaging (MRI) and a new lesion on a brain computed tomography (CT) scan\n* Within 72 hours of symptom onset\n* Good performance status\n* Signed an approved informed consents\n\nExclusion Criteria:\n\n* a history of hemorrhagic infarction, chronic kidney\u002Fliver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases",{"count":463,"type":22},500,"90 Days","CRAST is to analyze the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.",[442],[468],"circRNA","2024-08-04",{"date":471,"type":37},"2024-08-06",{"date":473,"type":37},"2020-10-01",{"date":475,"type":22},"2024-10-30",{"name":43,"class":44},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":484,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":485,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":45},"100536702","surgical-imaging-research-on-obesity-siro-100536702","NCT06268262","Surgical-imaging Research on Obesity (SIRO)","Surgical-imaging Combined Research on Obesity","Inclusion Criteria for obesity group:\n\nMeeting the obesity criteria (BMI \\> 28); 2) Meeting the indications for bariatric surgery, planning to undergo surgery for the first time; 3) Age between 18-65 years old, no gender restrictions; 4) Right-handed, of Han ethnicity; 5) Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.\n\nInclusion Criteria for the Control Group:\n\n1. Healthy volunteers with a BMI between 18.5-23.9;\n2. Age between 18-65 years old, no gender restrictions;\n3. Right-handed, of Han ethnicity;\n4. Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.\n\nExclusion Criteria for obesity group:\n\n1. Secondary obesity caused by other organic diseases or medication (such as hormone use, etc.);\n2. Unable to undergo surgery as planned;\n3. Pregnant or breastfeeding;\n4. Low cognitive ability and incapable of cooperating with the study;\n5. Eating disorders;\n6. Alcohol or drug dependence;\n7. Meeting the criteria for organic mental disorders, severe mental disorders (schizophrenia, etc.), or other serious mental illnesses requiring clinical intervention;\n8. Contraindications for MR scanning (pacemakers, cochlear implants, metal objects in the body, claustrophobia, weight exceeding the machine's load limit, etc.);\n9. History of neurological organic diseases (brain tumors, epilepsy, cerebrovascular accidents, severe head trauma, etc.);\n10. History of congenital heart disease (myocardial infarction, severe arrhythmias, heart failure, cardiomyopathy, rheumatic heart disease, congenital heart disease, etc.);\n11. Severe liver, kidney, lung, digestive dysfunction, endocrine, and blood system diseases;\n12. Active infections within the last two weeks (fever, upper respiratory infection, acute gastroenteritis, etc.);\n13. Use of drugs affecting the nervous system or psychotropic drugs within the last six months.\n\nExclusion Criteria for the Control Group:\n\nThe same criteria as points 3) to 13) above.",true,{"count":486,"type":22},200,"The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery.",[489],"Overweight and Obesity",[491,492,493,494,495],"Obesity","Overweight","MRI","Bariatric surgery","Fatty liver","2024-03-13",{"date":498,"type":37},"2024-03-15",{"date":500,"type":37},"2023-03-01",{"date":502,"type":22},"2028-12",{"name":43,"class":44},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":159,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":484,"sex":17,"minAge":161,"maxAge":162,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":516,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":523,"leadSponsor":524,"locationsCount":45},"100537410","effect-of-mutations-in-t2dm-susceptibility-genes-on-the-expression-of-susceptibility-genes-in-patients-with-t2dm-and-controls-100537410","NCT06277466","Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls","Inclusion Criteria:\n\n1. no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg\u002Fm2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）.\n2. 25 to 60 years old; BMI 19-26 kg\u002Fm2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous\u002Fmental system, endocrine system, etc（For healthy subjects）.\n3. 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）.\n\nExclusion Criteria:\n\n1. had taken antidiabetic drugs;\n2. had a history of pancreatic surgery;\n3. Complicated with severe organ lesions;\n4. Long-term use of drugs that affect pancreatic function.",{"count":164,"type":22},[84],"In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.\n\nParticipants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes.",[168,514,515,169],"Gene Polymorphisms","Genetic Mutations",[517,172,173,518],"T2DM","genetic mutations","2024-02-25",{"date":521,"type":37},"2024-02-28",{"date":179,"type":37},{"date":181,"type":22},{"name":43,"class":44},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":45},"100524094","early-phase-1-bgt007-cells-for-the-treatment-of-refractory-digestive-system-tumors-100524094","NCT06104241","BGT007 Cells for the Treatment of Refractory Digestive System Tumors","Clinical Study on the Safety and Initial Efficacy of BGT007 Cell Therapy in Patients With Recurrent\u002FMetastatic Refractory Digestive Tract Tumors","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent.\n2. Age ≥18 years old, ≤70 years old, male and female.\n3. Expected survival ≥ 3 months.\n4. The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1.\n5. Biopsy specimen or pathological wax section test (within 3 years before the signing of informed consent): Target protein test is positive.\n6. At least one measurable lesion according to RECIST v1.1 solid tumor evaluation criteria.\n7. Patients with recurrent\u002Fmetastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) who have previously received second-line or above standard treatment failure or intolerance.\n8. It is possible to establish a vein access for simple or intravenous blood collection, and there are no other contraindications for blood cell separation.\n9. having adequate organ and bone marrow function, as defined below: Blood routine examination Neutrophil count (NEU #) ≥1.0×10\\^9\u002FL Platelet count (PLT) ≥80×10\\^9\u002FL Hemoglobin concentration ≥90g\u002FL Liver function: subjects without liver metastases Aspartate aminotransferase (AST) ≤2.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) ≤2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL) ≤1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase (AST) ≤5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤5× Upper limit of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome Total bilirubin (TBIL) ≤2×ULN renal function Creatinine clearance (CCR) ≥50 mL\u002Fmin Coagulation function International Standardized ratio (INR) ≤1.5×ULN Activated partial thromboplastin time (APTT) ≤1.5×ULN\n10. Toxic side effects left over from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0).\n11. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose and the result are negative.\n\nExclusion Criteria:\n\n1. Active central nervous system metastases (except those stable after treatment).\n2. HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps\u002Fml), HCV antibody positive and HCV RNA positive.\n3. Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation.\n4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants.\n5. Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment.\n6. Any unstable systemic disease (including but not limited to):\n\n   Active infections (except local infections); unstable angina pectoris; cerebral ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure \\> 160mmHg\u002F100 mmHg).\n7. dysfunction of important organs such as lung, brain and kidney.\n8. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy or is expected to undergo major surgery during the study period.\n9. Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to an apheresis or within 5 half-lives, whichever is shorter.\n10. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years.\n11. Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months.\n12. Graft-versus-host disease (GVHD).\n13. Participants who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 h prior to cell transfusion (except for inhalation or topical use).\n14. Severe allergies or history of allergies.\n15. Subjects requiring anticoagulation therapy.\n16. Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both men and women)\n17. Researchers believe that there are other reasons for not being included in the treatment.",{"count":533,"type":22},14,[56],"This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007 injection in the treatment of recurrent\u002Fmetastatic\u002Frefractory digestive system tumors",[537],"Gastrointestinal Cancer",[539],"recurrent\u002Fmetastatic\u002Frefractory","2023-10-23",{"date":542,"type":37},"2023-10-27",{"date":544,"type":37},"2023-10-22",{"date":546,"type":22},"2027-10-20",{"name":43,"class":44},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":563,"leadSponsor":564,"locationsCount":45},"100524092","early-phase-1-bgt007h-cells-for-the-treatment-of-refractory-digestive-system-tumors-100524092","NCT06104215","BGT007H Cells for the Treatment of Refractory Digestive System Tumors","Clinical Study on the Safety and Initial Efficacy of BGT007H Cell Therapy in Patients With Recurrent\u002FMetastatic Refractory Digestive Tract Tumors","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent;\n2. Age ≥18 years old, ≤70 years old, male and female;\n3. Expected survival ≥ 3 months;\n4. The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1;\n5. Biopsy specimen or pathological wax section test (within 3 years before the signing of informed consent) : Target protein test is positive;\n6. At least one measurable lesion according to RECIST v1.1 solid tumor evaluation criteria;\n7. Patients with recurrent\u002Fmetastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) who have previously received second-line or above standard treatment failure or intolerance;\n8. It is possible to establish a vein access for simple or intravenous blood collection, and there are no other contraindications for blood cell separation;\n9. having adequate organ and bone marrow function, as defined below: Blood routine examination Neutrophil count (NEU #) ≥1.0×10\\^9\u002FL Platelet count (PLT) ≥80×10\\^9\u002FL Hemoglobin concentration ≥90g\u002FL Liver function: subjects without liver metastases Aspartate aminotransferase (AST) ≤2.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) ≤2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL) ≤1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase (AST) ≤5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤5× Upper limit of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome Total bilirubin (TBIL) ≤2×ULN renal function Creatinine clearance (CCR) ≥50 mL\u002Fmin Coagulation function International Standardized ratio (INR) ≤1.5×ULN Activated partial thromboplastin time (APTT) ≤1.5×ULN\n10. Toxic side effects left over from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0);\n11. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose and the result is negative.\n\nExclusion Criteria:\n\n1. Active central nervous system metastases (except those stable after treatment);\n2. HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps\u002Fml), HCV antibody positive and HCV RNA positive;\n3. Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;\n4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;\n5. Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment;\n6. Any unstable systemic disease (including but not limited to) :\n\n   Active infections (except local infections); unstable angina pectoris; cerebral ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure \\> 160mmHg\u002F100 mmHg);\n7. dysfunction of important organs such as lung, brain and kidney;\n8. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or is expected to undergo major surgery during the study period;\n9. Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to anapheresis or within 5 half-lives, whichever is shorter;\n10. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years;\n11. Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months;\n12. Graft-versus-host disease (GVHD);\n13. Participants who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 h prior to cell transfusion (except for inhalation or topical use);\n14. Severe allergies or history of allergies;\n15. Subjects requiring anticoagulation therapy;\n16. Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both men and women)\n17. Researchers believe that there are other reasons for not being included in the treatment.",{"count":533,"type":22},[56],"This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007H injection in the treatment of recurrent\u002Fmetastatic\u002Frefractory digestive system tumors.",[559],"Digestive Tract Cancer",[539],{"date":542,"type":37},{"date":544,"type":37},{"date":546,"type":22},{"name":43,"class":44},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":571,"minAge":18,"maxAge":129,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":45},"100466487","phase-1-clinical-study-of-psma-targeted-car-t-cells-in-the-treatment-of-castration-resistant-prostate-cancer-100466487","NCT05354375","Clinical Study of PSMA-targeted CAR-T Cells in the Treatment of Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Male patients aged from 18 to 75 years old;\n2. The patients' ECOG score ≤ 2;\n3. Prostate cancer patients in castration resistance stage (with or without distant metastasis):\n\n   1. Previous new endocrine therapy is ineffective;\n   2. Past treatment with too much citabine or cabatase is ineffective.\n4. Have measurable or evaluable lesions;\n5. The patients' main tissues and organs function well:\n\n   1. Liver function: ALT\u002FAST \\\u003C 3 times the upper limit of normal value (ULN);\n   2. renal function: creatinine \\\u003C 220 μ mol\u002FL;\n   3. Lung function: indoor oxygen saturation ≥ 95%;\n   4. Cardiac function: Left ventricular ejection fraction (LVEF)≥40%\n6. Patients or their legal guardians voluntarily participate and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.);\n2. Feasibility evaluation screening proves that the transfection of targeted lymphocytes is less than 10% or the amplification under the co-stimulation of CD3\u002FCD28 is insufficient (\\\u003C 5 times);\n3. The vital signs are abnormal and those who cannot cooperate with the inspectors;\n4. Those with mental illness or mental illness who can't cooperate with treatment and curative effect evaluation;\n5. Highly allergic constitution or severe allergic history, especially those who are allergic to IL-2;\n6. Subjects with systemic infection or local severe infection who need anti-infection treatment;\n7. Complicated dysfunction of heart, lung, brain, liver, kidney and other important organs;\n8. Patients with other tumors;\n9. Doctors think that there are other reasons that can't be included in the treatment.","MALE",{"count":54,"type":22},[109],"This is an experimental study to evaluate the safety and effectiveness of PSMA-targeted CAR-T cells in the treatment of castration-resistant prostate cancer.",[576],"Immunotherapy",[578,579,291,580,581],"Prostate specific membrane antigen","Castration-resistant Prostate Cancer","Chimeric antigen receptor","T cell","2022-04-26",{"date":584,"type":37},"2022-04-29",{"date":586,"type":22},"2022-12-01",{"date":588,"type":22},"2026-11-30",{"name":43,"class":44},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":603,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":45},"100464092","phase-1-study-of-b7h3-car-t-cells-in-treating-advanced-liver-cancer-100464092","NCT05323201","Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer","A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of B7H3 or HBsAg Targeting CAR-T in Treating Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Subjects should be 18-70 years old.\n2. Subject has adequate performance status as defined by ECOG score of≤ 2.\n3. Expected life expectancy is no less than 12 weeks.\n4. Subjects must have histologically or cytologically confirmed unresectable, recurrent and \u002F or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression.\n5. Child-Pugh A, B grade.\n6. Blood routine:\n\n   white blood cell count≥ 2.5 × 10\\^9 \u002F L; hemoglobin≥ 9 g\u002FdL; platelet count≥ 50 × 10\\^9 \u002F L; lymphocyte proportion≥ 15 %;\n7. Adequate organ function. Patients' main organs ( heart, lung, liver, kidney, etc. ) function well:\n\n   ALT and AST≤ 5 × ULN; ALB≥ 30 g\u002FL； Total bilirubin≤ 2.5 × ULN； Serum creatinine\\\u003C 220μmol\u002FL; Indoor oxygen saturation ≥ 95 %; Left ventricular ejection fraction≥ 40%;\n8. No allergic reaction to contrast agents.\n9. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production.\n10. Patients or their legal guardians voluntarily participate in and sign the informed consent form.\n\nExclusion Criteria:\n\n1. The subject is a pregnant or lactating woman.\n2. The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis, etc.);\n3. The subject has active infection or coagulation dysfunction.\n4. Subjects with previous hepatic encephalopathy.\n5. The subject is on anticoagulation or antiplatelet therapy.\n6. The subject is an organ transplant or waiting for transplant.\n7. Subjects with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation.\n8. The subjects are highly allergic or have a history of severe allergies.\n9. The subject has received chemotherapy\u002Fradiotherapy within the past 4 weeks.\n10. The subject has a history of cellular immunotherapy or antibody therapy.\n11. The subject is receiving systemic hormone therapy.\n12. Subjects with systemic infection or severe local infection requiring anti-infection treatment.\n13. The subject has dysfunction of important organs such as heart, lung, brain, liver, and kidney.\n14. The subject is participating in other clinical research.\n15. The doctor believes that there are other reasons not to be included in the treatment.\n16. Unwilling or unable to provide consent\u002Fassent for participation in the study.",{"count":598,"type":22},15,[109,25],"This is single center, open-label phase I\u002FII, non-randomized study which will enroll patients with recurrent advanced hepatocellular carcinoma to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T in treating hepatocellular carcinoma.",[602],"Hepatocellular Carcinoma",[604,605],"Fully human B7H3 CAR-T","Recurrent Advanced Hepatocellular Carcinoma","2022-04-05",{"date":608,"type":37},"2022-04-12",{"date":610,"type":37},"2022-02-10",{"date":612,"type":22},"2027-02-10",{"name":43,"class":44},""]