[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Jiao Tong University School of Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":629},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,80,0,25,[9,43,73,98,127,157,179,201,226,256,281,304,330,356,383,401,425,444,469,489,516,542,564,585,607],{"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":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643612","phase-1-pd-1-antibody-and-jak1-inhibitor-for-newly-diagnosed-pediatric-hodgikins-lympoma-100643612",false,"NCT07641010","PD-1 Antibody and JAK1 Inhibitor for Newly Diagnosed Pediatric Hodgikin's Lympoma","A Prospective, Multicenter, Randomized Controlled Clinical Study of Camrelizumab in Combination With Ivarmacitinib as First-line Treatment for Pediatric Classical Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Age 6-18 years, male or female;\n2. Histologically confirmed classic Hodgkin lymphoma;\n3. Newly diagnosed, previously untreated patients;\n4. Subjects must have at least one measurable lesion, defined as: a lymph node lesion with the longest diameter \\>1.5 cm on CT cross-sectional imaging; or an extranodal lesion with the longest diameter \\>1.0 cm;\n5. ECOG performance status (PS) 0-2;\n6. Life expectancy ≥3 months;\n7. All screening laboratory tests must be performed as required by the protocol and within 7 days prior to enrollment. The laboratory values obtained at screening must meet the following criteria:\n8. Hematology (without blood transfusion, G-CSF, or medication to correct abnormalities within 14 days prior to screening):\n\n   * Hemoglobin (Hb) ≥70 g\u002FL;\n   * Absolute neutrophil count (ANC) ≥0.5×10⁹\u002FL;\n   * Platelet count (PLT) ≥30×10⁹\u002FL;\n9. Biochemistry:\n\n   * Direct bilirubin (DBIL) \\\u003C2 × upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN;\n   * Serum creatinine clearance ≥40 mL\u002Fmin;\n10. The patient or his\u002Fher legal guardian has signed the informed consent form (ICF) and voluntarily agrees to participate in this study.\n\nExclusion Criteria:\n\n1. Histopathologically confirmed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL);\n2. Prior anti-tumor therapy for classic Hodgkin lymphoma (cHL);\n3. Patients with central nervous system (CNS) involvement by lymphoma;\n4. Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption;\n5. Presence of any active, known, or suspected autoimmune disease (subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll);\n6. Use of immunosuppressive agents, including systemic corticosteroids, within 14 days prior to study drug administration (use of ≤10 mg\u002Fday prednisone or equivalent is permitted);\n7. History of other malignancies within the past 5 years;\n8. Severe cardiac dysfunction with ejection fraction (EF) \\\u003C50%, or severe cardiac arrhythmia;\n9. Any arterial thromboembolic event within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;\n10. Active hepatitis B or hepatitis C infection;\n11. History of stroke or intracranial hemorrhage within the past 6 months;\n12. Known history of human immunodeficiency virus (HIV) positivity.","ALL","6 Years","18 Years",{"count":21,"type":22},112,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma",[29],"Hodgkin Lymphoma","NOT_YET_RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":22},"2026-06-30",{"date":38,"type":22},"2030-09-30",{"name":40,"class":41},"Shanghai Jiao Tong University School of Medicine","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100642077","circadian-synchronized-breast-milk-feeding-and-sleep-in-preterm-infants-a-multicenter-randomized-controlled-trial-100642077","NCT07645677","Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial","Effect of Circadian-Synchronized Breast Milk Feeding on Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\nPreterm infants born between 28 and 36 weeks of gestation Have reached full enteral feeding Written informed consent signed by a legal guardian\n\nExclusion Criteria:\n\nNeed invasive respiratory support, such as endotracheal intubation Use of sedatives or other medications that may affect the central nervous system or sleep rhythm\n\nPresence of diseases or abnormalities that may affect normal feeding or sleep behavior, including:\n\nCongenital anomalies, such as neurologic or chromosomal abnormalities Congenital gastrointestinal malformations or anorectal malformations Conditions affecting digestion or absorption, such as diarrhea, intestinal obstruction, or necrotizing enterocolitis (NEC) Critical illnesses such as patent ductus arteriosus (PDA), neonatal sepsis, neutropenia, or coagulation disorders","0 Days",{"count":52,"type":22},120,[54],"NA","This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU).\n\nThe study mainly aims to answer the following questions:\n\nCan this feeding approach improve sleep in preterm infants? Can this feeding approach help preterm infants develop more regular sleep patterns compared with routine breast milk feeding?\n\nResearchers will compare a feeding approach that tries to match the time when breast milk was expressed with the time when the baby is fed, with routine breast milk feeding, to see whether this method can improve sleep in preterm infants.\n\nParticipants will:\n\nBe randomly assigned to 1 of 2 groups: circadian-synchronized breast milk feeding or routine breast milk feeding.\n\nReceive the assigned feeding approach for at least 2 weeks during the study. Have one 12-hour continuous sleep monitoring session at 37 weeks of corrected age.\n\nHave changes in different sleep states recorded and analyzed during the study, so that sleep patterns can be compared between the 2 groups.",[57,58],"Preterm Infant","Sleep",[60,61,62,63,57,58],"Breast Milk Feeding","Circadian Rhythm","Chrononutrition","NICU","2026-06-09",{"date":66,"type":34},"2026-06-12",{"date":68,"type":22},"2026-06-01",{"date":70,"type":22},"2027-08-01",{"name":40,"class":41},6,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":42},"100632636","effect-of-ppis-on-stool-dna-test-for-h-pylori-100632636","NCT07516262","Effect of PPIs on Stool DNA Test for H. Pylori","Effect of Proton Pump Inhibitors on Stool DNA Detection of Helicobacter Pylori: A Prospective Clinical Study","Inclusion Criteria:\n\n* Male or female patients aged 18-80 years;\n* No prior H. pylori eradication therapy;\n* Patients requiring proton pump inhibitor (PPI) therapy in the near future due to gastritis, peptic ulcer disease, or other indicated conditions;\n* Patients with at least two positive results among H. pylori antibody test, histology, and rapid urease test (RUT);\n* Provision of signed informed consent and being informed of the specific study protocol.\n\nExclusion Criteria:\n\n* Prior H. pylori eradication therapy;\n* Pregnant or lactating women;\n* Acute gastrointestinal bleeding;\n* History of subtotal gastrectomy;\n* Severe dysfunction of vital organs (heart, liver, kidney, lungs, etc.) or congenital diseases, such as class IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.;\n* Refusal of enrollment by the guardian or the patient;\n* Alcohol and\u002For drug abuse (addiction or dependence), or poor compliance as judged by the investigator;\n* Individuals without legal capacity or with impaired insight;\n* Abnormal neurological signs on physical examination;\n* Use of oral antibiotics with bactericidal activity against H. pylori within 4 weeks.","80 Years",{"count":7,"type":22},"OBSERVATIONAL","This prospective, self-controlled clinical study aims to evaluate the impact of proton pump inhibitor (PPI) use on the accuracy of stool DNA testing for Helicobacter pylori (H. pylori) and to assess the applicability of this test in patients receiving PPI therapy. Patients requiring long-term PPI treatment and meeting the inclusion criteria were enrolled. After at least four weeks of PPI therapy, a stool DNA test was performed, along with collection of gastric mucosal samples via gastroscopy for tissue PCR, histology, and rapid urease testing, as well as H. pylori antibody detection. Subsequently, PPI treatment was discontinued for four weeks, after which a 13C-urea breath test and a repeat stool DNA test were conducted. By comparing the sensitivity, specificity, and consistency of stool DNA testing before and after PPI discontinuation, this study aims to characterize the interference of PPIs with the test results, thereby providing evidence to support improvements in H. pylori diagnostic methods.",[85],"Helicobacter Pylori Infection",[87,88,89],"Helicobacter pylori","Stool DNA Testing","Proton pump inhibitors","RECRUITING","2026-06-04",{"date":93,"type":34},"2026-06-05",{"date":95,"type":34},"2025-05-01",{"date":36,"type":22},{"name":40,"class":41},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100616299","phase-2-a-study-of-chiglitazar-in-patients-with-metabolic-dysfunction-associated-steatohepatitis-and-type-2-diabetes-mellitus-100616299","NCT07303803","A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus","Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for the Treatment in MASH Associated With T2DM: a Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Study","CHIG-MASH","Inclusion Criteria:\n\n1. Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.\n2. Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.\n3. Participants must take Fibroscan examination with the result of CAP ≥ 238 dB\u002Fm and LSM\\>8.5 kPa.\n4. Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1b or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver biopsy not more than 6 months prior to screening)\n5. Stable body weight (≤10% body weight change) for at least 3 months.\n6. Possess good understanding and behavior and be able to take the medication daily as required by the trial.\n7. Willing to sign the informed consent.\n\nExclusion Criteria:\n\n1. Alcohol consumption \\>20g ethyl alcohol\u002Fday for women and \\>40g ethyl alcohol\u002Fday for men.\n2. Evidence of other forms of chronic liver disease:\n\n   1. Alcoholic liver disease,\n   2. Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,\n   3. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),\n   4. Evidence of autoimmune liver disease as defined by compatible liver histology,\n   5. Current drug-induced liver disease as defined on the basis of typical exposure and history,\n   6. Suspected or proven liver cancer,\n   7. Any other type of liver disease other than MASH.\n3. Uncontrolled T2DM defined as HbA1c \\>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).\n4. Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.\n5. Any of the following cardiovascular conditions within 6 months prior to screening:\n\n   1. acute myocardial infarction (MI),\n   2. cerebrovascular accident (stroke),\n   3. unstable angina,\n   4. hospitalization due to congestive heart failure (CHF)\n   5. New York Heart Association Functional Classification IV CHF\n6. History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.\n7. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥ 100 mm Hg).\n8. Renal impairment measured as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n9. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.\n10. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).\n11. Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.\n12. A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.\n13. Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial (at least include one barrier contraceptive method) and breast feeding.\n14. Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.\n15. Current use of medication is associated with weight gain, except when on stable dose for at least 3 months prior to screening and remaining on stable dose during the study.\n16. Receiving or having received (within 3 months of screening) chronic (\\>2 weeks) systemic glucocorticoid therapy.\n17. Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists).\n18. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.","75 Years",{"count":108,"type":22},300,[26],"This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.",[112,113],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","T2DM (Type 2 Diabetes Mellitus)",[115,116,117,118],"chiglitazar","metabolic dysfunction-associated steatohepatitis","type 2 diabetes","liver biopsy",{"date":120,"type":34},"2026-06-03",{"date":122,"type":34},"2026-01-01",{"date":124,"type":22},"2030-12-01",{"name":40,"class":41},17,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":17,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":42},"100139372","genetics-of-obesity-in-chinese-youngs-100139372","NCT01084967","Genetics of Obesity in Chinese Youngs","Study of Clinical Characteristics and Genetic Susceptibility in Chinese Obese Youngs","GOCY","Inclusion Criteria:\n\n* body mass index (BMI)≥ 30kg\u002Fm2\n* predominantly east China to minimize population stratification\n* willing and able to provide informed consent\n\nExclusion Criteria:\n\n* pregnancy\u002Flactation\n* Cushing syndrome\n* Hypothyroidism\n* obesity caused by pituitary and hypothalamic lesions\n* drug related obesity\n* history of major psychiatric illness",true,"14 Years","30 Years",{"count":139,"type":22},8000,"The purpose of this study is to explore the pathogenesis and genetic susceptibility of obese subjects,providing a convincing argument for further treatment of obesity and metabolic syndrome.",[142,143],"Obesity","Metabolic Syndrome",[145,146,147,148],"obesity","metabolic syndrome","genetic risk markers","copy number variation","2026-05-07",{"date":151,"type":34},"2026-05-12",{"date":153,"type":4},"2009-03",{"date":155,"type":22},"2030-04",{"name":40,"class":41},{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":164,"maxAge":19,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":42},"100638218","support-system-design-for-adolescent-scoliosis-orthosis-wear-100638218","NCT07574229","Support System Design for Adolescent Scoliosis Orthosis Wear","A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback","Eligibility Criteria\n\nInclusion Criteria:\n\nClinical diagnosis of Adolescent Idiopathic Scoliosis (AIS).\n\nCurrent orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces).\n\nBetween 10 and 18 years of age at the time of enrollment.\n\nAbility to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires.\n\nAccess to a stable home environment with Wi-Fi or local network connectivity for the interactive desktop terminal.\n\nWillingness of the participant to provide assent and the legal guardian to provide written informed consent.\n\nExclusion Criteria:\n\nSecondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome).\n\nScheduled spinal surgery within the planned study period.\n\nSevere skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration.\n\nPrevious participation in similar digital intervention studies for scoliosis management.\n\nDiagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.","10 Years",{"count":166,"type":22},18,[54],"This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated \"Product System\" designed to transform the bracing experience from a burdensome task into a guided, supportive journey. This system consists of three main components:Smart Sensing: Discrete, thin-film pressure sensors are integrated into the existing brace to monitor real-time wear time and fit quality without compromising comfort.Interactive Desktop Terminal: A dedicated device for the home that uses \"narrative-driven\" feedback (themed around a journey called \"The Spine's Path\"). Instead of cold medical data, it provides intuitive progress visualizations and rewards to keep participants engaged.Mobile Support App: A tool for both participants and parents to track long-term trends, access educational resources, and facilitate communication with healthcare providers.The Goal of the Study The primary objective is to evaluate how this digital intervention affects a participant's \"Intrinsic Motivation\"-the internal drive to adhere to treatment. By focusing on three psychological dimensions-Interest\u002FEnjoyment, Perceived Competence, and Pressure\u002FTension-the investigators aim to determine if interactive feedback can reduce the \"medical feel\" of the brace and help teenagers feel more in control of the recovery.What Participation Involves Participants will use the product system during the daily routine in home and school environments. The investigators will collect objective data (brace usage hours) and subjective data (through the Intrinsic Motivation Inventory\u002FIMI scale) to measure changes in behavior and mental well-being.Benefits for Families and ProvidersFor Participants: A more engaging, less stressful way to manage the condition and see real-time progress.For Families: Reduced friction regarding brace-wearing and better visibility into the participant's treatment status.For Healthcare Providers: Access to accurate, objective data on participant compliance, allowing for more personalized and effective clinical adjustments.",[170,171],"Adolescent Idiopathic Scoliosis (AIS)","Adherence","2026-05-03",{"date":149,"type":34},{"date":175,"type":34},"2026-02-01",{"date":177,"type":22},"2026-10-01",{"name":40,"class":41},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100636832","efficacy-safety-and-tolerability-of-cs0159-combined-with-semaglutide-in-mafld-patients-with-obesity-and-t2dm-100636832","NCT07570810","Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM","A Single -Center, Randomized, Double-blind, Placebo-controlled Proof of Exploratory Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM","Inclusion Criteria:\n\n* 1\\. Age≥18 and ≤65 years, male or female.\n* 2\\. MRI-PDFF ≥10% within 3 months prior to randomized.\n* 3\\. Diagnosis of T2DM.\n* 4\\. HbA1c: 7.0%-10.5%.\n* 5\\. FPG: 7.0-13.3 mmol\u002FL.\n* 6\\. BMI: 30-45 kg\u002Fm2.\n* 7\\. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.\n* 8\\. Willing to maintain consistent diet and exercise habits throughout the entire study, and adhere to the study protocol for timely administration of the study drug, and timely self-monitoring of blood glucose and recording.\n* 9\\. Can understand the research content, follow the research protocol, and voluntarily sign the ICF.\n\nExclusion Criteria:\n\n* 1\\. ALT≥2.5×ULN, AST≥2.5×ULN, TBil≥2×ULN, creatinine (Cr) ≥1.5×ULN and Serum creatinine clearance\\\u003C60 mL\u002Fmin, PLT\\\u003C100×10\\^9\u002FL, INR \\>1.3, ALB \\\u003C3.5 g\u002FdL.\n* 2\\. Use of glucose-lowering medication in the 3 months prior to randomization.\n* 3\\. Weight loss ≥ 5% in the 3 months prior to randomization or ≥10% in the 6 months prior to randomization or use of other weight-lowering drugs, corticosteroids, and etc.\n* 4\\. History of allergy to glucagon-like peptide-1 receptor agonists (GLP-1RA) medications, currently in an allergic state, having allergic conditions, or history of allergies to ≥2 substances.\n* 5\\. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.\n* 6\\. Subjects with a history of severe pruritus.\n* 7\\. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.\n* 8\\. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.\n* 9\\. History of acute or chronic pancreatitis.\n* 10\\. Subjects with Child-Pugh class B or C grade cirrhosis.\n* 11\\. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.\n* 12\\. Arrhythmias, male QTc≥450 ms, or female QTc≥470 ms. Or cardiovascular disease for which the researcher has assessed that participation in the trial is not appropriate.\n* 13\\. Diseases that interfere with the absorption, distribution, metabolism or excretion.\n* 14\\. Gastrointestinal diseases that affect food digestion and absorption.\n* 15\\. Use moderate or strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A4 enzyme) within the first 14 days of randomization and throughout the entire trial period.\n* 16\\. History of malignant tumors within the first 5 years of randomization.\n* 17\\. Serious hypoglycemic events occurring ≥ 3 times within 12 weeks prior to administration, or acute and severe metabolic disorder occurred within 12 weeks prior to administration.\n* 18\\. Drug abuse or alcohol abuse within the first 6 months of randomization.\n* 19\\. Poor blood pressure control.\n* 20\\. Mental illness, epilepsy.\n* 21\\. Patients with uncontrollable severe infectious diseases before randomization.\n* 22\\. Pregnant, planned pregnancy or breastfeeding.\n* 23\\. Participated in other clinical trials in the first three months of randomization.\n* 24\\. Any condition that in the judgement of the researcher precludes participation.","65 Years",{"count":188,"type":22},30,[54],"This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).",[192,142,193],"Type 2 Diabetes","Non-alcoholic Fatty Liver Disease","2026-05-01",{"date":196,"type":34},"2026-05-06",{"date":68,"type":22},{"date":199,"type":22},"2026-12-31",{"name":40,"class":41},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":135,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":212,"studyType":82,"phases":4,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":223,"leadSponsor":225,"locationsCount":42},"100625676","early-myocardial-dysfunction-helps-identify-severe-refractory-pediatric-lupus-100625676","NCT07425730","Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus","Myocardial Dysfunction in Pediatric Lupus","Inclusion Criteria:\n\n* fulfill the American College of Rheumatology (ACR) criteria\n* disease onset at ages before 18 years\n\nExclusion Criteria:\n\n* patients with a history of concomitant malignancy\n* patients with active bacterial, viral, fungal, mycobacterial infection","7 Years","17 Years",{"count":211,"type":22},60,"6 Months","To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques.",[215],"Systemic Lupus Erythematosus (SLE)",[217,218],"lupus","echocardiography","2026-04-22",{"date":221,"type":34},"2026-04-28",{"date":175,"type":34},{"date":224,"type":22},"2026-07-01",{"name":40,"class":41},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":233,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":243,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100634132","phase-1-aclarubicin-plus-cyclophosphamide-vincristine-and-prednisone-caop-in-patients-with-previously-treated-cutaneous-t-cell-lymphoma-100634132","NCT07535710","Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma","A Multicenter, Open-Label, Phase 1\u002F2 Clinical Study of the Safety and Efficacy of Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form\n2. Age ≥ 60 years at enrollment\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n4. Histologically confirmed primary cutaneous T-cell lymphoma (CTCL) or Sézary syndrome (SS) (according to the fifth edition of the WHO Classification of Tumors of the Hematopoietic and Lymphoid System)\n5. Stage II-B, III, or IV (referring to the Olsen criteria of the International Society for Cancer Research (ISCL)\u002FUSCC\u002FEORTC, 2022)\n6. Patients who have failed at least one systemic therapy; psoralen combined with ultraviolet radiation therapy (PUVA) is not considered a systemic therapy\n7. All clinically significant toxicities caused by previous anticancer therapy have resolved to ≤ Grade 1 (according to NCI-CTCAE v5.0 criteria)\n8. Hematological, renal, and liver function tests meet the following requirements:\n\n   1. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002FμL\n   2. Platelet count ≥ 100,000 cells\u002FμL\n   3. For patients with known bone marrow involvement, ANC ≥ 1,000 cells\u002FμL and platelets ≥ 75,000 cells\u002FμL\n   4. Total bilirubin ≤ 1.5 times the institutional upper limit of normal (ULN) (except for patients with Gilbert syndrome)\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known in C TCL, ≤ 5.0 × ULN\n   6. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance calculated by the Cockcroft-Gault formula \\> 50 mL\u002Fmin\n\nExclusion Criteria:\n\n1. Patients diagnosed with a malignancy within the past two years. Exclude the following situation: non-melanoma skin cancer, melanoma in situ, localized prostate cancer (current PSA \\\u003C0.1 ng\u002FmL), treated thyroid cancer; or cervical carcinoma in situ or breast ductal\u002Flobular carcinoma in situ diagnosed within the past two years, as long as there is no current evidence of active disease.\n2. Clinical evidence of central nervous system (CNS) infiltration.\n3. Large cell transformation (LCT). Patients with a history of LCT but no current invasive disease and no evidence of LCT on skin or lymph node pathology may be enrolled.\n4. Psychiatric illness, disability, or social circumstances that may affect the subject's safety, ability to provide informed consent, or poor compliance.\n5. Patients with significant uncontrolled comorbidities or infections, as follows:\n\n   1. Uncontrolled infection requiring intravenous antibiotics\n   2. Clinically significant heart disease (New York Heart Association class III or IV), unstable angina\n   3. History of angioplasty, stent implantation, or myocardial infarction within 6 months\n   4. Uncontrolled hypertension despite treatment with two antihypertensive medications (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg, measured on two consecutive occasions, one week apart)\n   5. Clinically significant arrhythmias\n   6. Uncontrolled diabetes mellitus\n6. Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C.\n7. Active herpes simplex or herpes zoster. Patients who have started antiviral prophylaxis ≥30 days prior to the pretreatment visit, have no signs of active infection, and whose last active infection occurred more than 6 months ago may be enrolled and must continue taking prescribed medications during the study.\n8. Known active autoimmune disease (e.g., Graves' disease, systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, psoriasis).\n9. Allergic reaction to study medications.\n10. History of allogeneic transplantation.\n11. Pregnancy (confirmed by β-hCG) or lactation.","60 Years",{"count":235,"type":22},37,[25,26],"Cutaneous T-cell lymphomas (CTCL) are a rare and heterogeneous group of extranidal T-cell lymphomas characterized by skin involvement. Current treatment options for CTCL are limited. Although responses have been demonstrated, their duration is often short, especially in patients with advanced stage disease. Additional treatment options are needed which demonstrate activity in cutaneous and extracutaneous sites. The traditional CHOP regimen (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone) has some efficacy for CTCL patients, but due to the cardiotoxicity of anthracyclines, patients can only receive a limited course of treatment. After stopping the regimen, most patients will experience relapse.\n\nAclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. Aclarubicin's treatment indications include malignant lymphoma, but actual clinical application experience is limited.\n\nThe purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with cyclophosphamide, vincristine, and prednisone (CAOP) for subjects with relapsed or refractory CTCL.",[239,240,241,242],"Cutaneous T-Cell Lymphoma Refractory","Cutaneous T-Cell Lymphoma, Relapsed","Sezary Syndrome","Cutaneous T Cell Lymphoma (CTCL)",[244,245,241,246],"Aclarubicin","CTCL","systemic therapy","2026-04-14",{"date":249,"type":34},"2026-04-17",{"date":251,"type":22},"2026-03-30",{"date":253,"type":22},"2028-12-31",{"name":40,"class":41},2,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":271,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":278,"leadSponsor":280,"locationsCount":255},"100634136","phase-2-aclarubicin-plus-cyclophosphamide-vincristine-and-prednisone-caop-in-patients-with-previously-untreated-peripheral-t-cell-lymphoma-100634136","NCT07535762","Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T-Cell Lymphoma","A Prospective, Single-Arm, Multi-center, Phase 2 Study of Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T-Cell Lymphoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form\n2. Age ≥ 65 years at enrollment\n3. ECOG performance status score ≤ 2\n4. Able to comply with the research visit plan and other protocol requirements\n5. Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have not previously received treatment\n\n   The following subtypes as defined by the World Health Organization (WHO) classification (2022) are eligible, with Ann Arbor stage I-IV, and pathological immunohistochemical CD30 negative:\n   1. Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)\n   2. Nodal T-follicular helper cell lymphoma (TFH)\n   3. Anaplastic large cell lymphoma, ALK-negative (ALCL)\n6. Life expectancy ≥ 3 months\n7. Hematological, renal, and hepatic function all meet the requirements:\n\n   1. Absolute neutrophil count (ANC) ≥ 1,500\u002FμL\n   2. Platelet count ≥ 100,000\u002FμL\n   3. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the institution (except for patients with Gilbert's syndrome)\n   4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known, then ≤ 5.0 × ULN\n   5. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance \\> 50 mL\u002Fmin calculated by the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n1. Mental illness, disability, or social circumstances that may affect participant safety, ability to provide informed consent, or poor adherence\n2. Other types of lymphoma\n3. Previous immunotherapy or chemotherapy for PTCL, excluding those who used corticosteroids (≤8 days) prior to enrollment\n4. Previous radiotherapy for PTCL, excluding those confined to a single lymph node region\n5. Pathological immunohistochemistry showing CD30 positivity and\u002For ALK positivity\n6. Patients planning to receive autologous or allogeneic transplantation as first-line consolidation therapy\n7. Confirmed central nervous system\u002Fmeningeal involvement\n8. Significant uncontrolled comorbidities or infections, specifically:\n\n   1. Uncontrolled infection requiring intravenous antibiotics\n   2. Clinically significant heart disease (NYHA Class III or IV), unstable angina\n   3. History of angioplasty, stent implantation, or myocardial infarction within the past 6 months\n   4. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg) despite using two antihypertensive medications. (or diastolic blood pressure \\>100 mmHg, measured twice consecutively, one week apart)\n   5. Clinically significant cardiac arrhythmias\n   6. Uncontrolled diabetes\n9. Known or detected positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C.\n10. Patients diagnosed with malignancy within the past two years. However, the following are excluded: non-melanoma skin cancer, melanoma in situ, localized prostate cancer (current PSA \\\u003C0.1 ng\u002FmL), treated thyroid cancer; or cervical carcinoma in situ or breast ductal\u002Flobular carcinoma in situ within the past two years, provided there is currently no evidence of active disease.",{"count":264,"type":22},36,[26],"Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of rare disorders that result from clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas. The most common subtype of PTCL is classified as \"not otherwise specified\" (NOS) which accounts for 30-40%.\n\nPTCLs have been treated similarly with CHOP (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone), often with etoposide (CHOEP), followed by high-dose therapy and autologous stem cell transplantation (ASCT) in first remission. However, \\\u003C50% of the patients are cured with CHOP alone, and the progression-free survival rates at 5 years are as low as 20% for PTCLs. Meanwhile, for elderly patients who can't endure CHOPE and proceed ASCT, the long-term survival is even worse.\n\nAclarubicin is an anthracycline which showed good safety profile in the treatment of both myeloid and lymphocytic leukemia. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached.\n\nThe purpose of this study is to determine the efficacy of Aclarubicin, Cyclophosphamide, Vincristine, and Prednisone (CAOP) in elderly patients with newly diagnosed PTCLs. The investigators hope to try to replace doxorubicin in CHOP with aclarubicin, which is less toxic, without reducing the efficacy of patients while ensuring safety.",[268,269,270],"Peripheral T-Cell Lymphoma (PTCL NOS)","Nodal T-follicular Helper Cell Lymphoma","Anaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative)",[272,273,274,275],"PTCL","aclarubicin","elderly patients","ALCL, ALK-negative",{"date":249,"type":34},{"date":251,"type":22},{"date":279,"type":22},"2028-12-30",{"name":40,"class":41},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":42},"100526947","treatment-of-advanced-endocrine-tumor-with-iindividualized-mrna-neoantigen-vaccine-mrna-0523-l001-100526947","NCT06141369","Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)","Inclusion Criteria:\n\n1. The subjects voluntarily sign the written informed consent form and can comply with the visits and related procedures specified in the protocol;\n2. The subjects are 18 years old or older, regardless of gender;\n3. Patients with advanced endocrine tumors confirmed by histology or cytology in the past 6 months (including medullary thyroid carcinoma, thymic carcinoma and adrenal cortical carcinoma, etc.), who have failed standard treatment or have no standard treatment available;\n4. No HLA-related genes or chromosomal regions with copy number variations (CNVs) or loss of heterozygosity (LOH) were detected by gene sequencing;\n5. They have advanced or metastatic lesions confirmed by immunohistochemistry, and have frozen tissue\u002Fcells sufficient for WES and RNAseq sequencing, and after bioinformatics analysis, they predict at least one antigen that is effectively presented by their own HLA, such as KRAS or TP53 mutations and corresponding HLA typing, see 1.4 for the rationale of the topic.\n6. Expected survival ≥ 4 months;\n7. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), they have at least one measurable lesion, which should not have received local treatment such as radiotherapy (lesions in the previous radiotherapy area, if confirmed to have progressed, can also be selected as target lesions);\n8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;\n9. They have not used granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion or platelet transfusion within 14 days before the examination.\n10. Subjects of childbearing potential (male and female) who meet the inclusion criteria must agree to use reliable contraception methods (hormonal or barrier methods or abstinence) during the trial and for at least 90 days after the last administration; women of childbearing age must have a negative blood pregnancy test within 7 days before the first administration.\n11. Virology test: No CMV, EBV, HIV, HBV, HCV, syphilis infection (only at baseline)\n\nExclusion Criteria:\n\n1. Received chemotherapy, hormone therapy, traditional Chinese medicine with anti-tumor indications or other anti-tumor treatments within 4 weeks before the first administration (for mitomycin and nitrosourea, the last administration was within 6 weeks before the first administration of this study drug), or within 5 half-lives of immunotherapy or molecular targeted therapy;\n2. Received other major surgery other than diagnosis or biopsy within 4 weeks before the first administration, or expected to receive major surgery during the study;\n3. Patients who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or plan to receive organ transplantation during this study;\n4. Patients who have received other tumor vaccines or cell therapies in the past; Medical condition\n5. Patients with clinically symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence indicating that the patient's brain or spinal cord metastases are not controlled, and are deemed unsuitable for enrollment by the investigator;\n6. In the past 2 years, there have been known other malignant tumors that are progressing or require active treatment (except for non-melanoma skin cancer, superficial bladder cancer, and cervical carcinoma in situ that have been cured by radical surgery);\n7. Have a history of interstitial lung disease (ILD) or pulmonary interstitial fibrosis;\n8. Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: a) Have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block; corrected QTc interval male \\> 450 milliseconds, female \\> 470 milliseconds, b) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first administration, c) New York Heart Association (NYHA) ≥ III grade heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%.\n9. Other serious and\u002For uncontrollable diseases that may affect the subject's participation in this study, as determined by the investigator, including but not limited to: a) Have a history of severe drug allergy, or known to be allergic to any component of the tumor vaccine; or have had a severe allergic reaction to other monoclonal antibodies in the past, b) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, c) Evidence of severe or uncontrolled liver or kidney disease, d) Poorly controlled hypertension, diabetes, etc., e) Patients with active ulcers or gastrointestinal bleeding f) Have a severe infection that requires intravenous infusion of antibiotics or hospitalization; or uncontrolled active infection within 4 weeks before the first administration, g) Have active syphilis infection.\n10. Participated in other clinical trials within 4 weeks before the first administration (except for screening failure);\n11. Currently receiving systemic use of corticosteroids (except for recent or current use of inhaled corticosteroids);\n12. Pregnant or lactating women; Laboratory and imaging examinations\n13. Imaging (CT or MRI) shows that the tumor invades the large blood vessels and has a tendency to bleed;\n14. Have clinically significant thyroid function abnormalities, and the investigator deems them unsuitable for enrollment;\n15. Active pneumonia was found in the screening chest CT scan;\n16. Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;\n17. The adverse reactions of previous anti-tumor treatment have not recovered to NCI-CTCAE 5.0 grade evaluation ≤ 1 (except for hair loss);\n18. Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) test value higher than the upper limit of normal; hepatitis C virus antibody (HCV Ab) positive and HCV RNA test value higher than the upper limit of normal; Investigator assessment\n19. The investigator considers that there are other reasons that are not suitable for participating in the clinical trial.",{"count":288,"type":22},21,[54],"Treatment of advanced endocrine tumors, including adrenal corticocarcnioma (ACC), medullary thyroid carcinoma (MTC), thymic neuroendocrine tumor and pancreatic neuroendocrine tumor is challenging. Previous genomic profiling studies showed they presented a number of somatic mutations. The tumors Individualized mRNA neoantigen vaccine provide a promising solution since a significant portion of these tumors showed high quality of tumor specific neoantigen. The primary objective is to observe and evaluate the safety and tolerability of individualized mRNA neoantigen vaccine (mRNA-0523-L001) for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available. The secondary objective is to observe the preliminary efficacy of mRNA-0523-L001 for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available, including:\n\n1. Neoantigen-specific CD4+ and CD8+ T lymphocyte responses induced by mRNA-0523-L001;\n2. Objective response rate (ORR) and disease control rate (DCR) of tumors;\n3. Progression-free survival (PFS).",[292,293,294,295],"Adrenal Cortical Carcinoma","Medullary Thyroid Cancer","Thymic Neuroendocrine Carcinoma","Pancreatic Neuroendocrine Tumor","2026-04-05",{"date":298,"type":34},"2026-04-09",{"date":300,"type":34},"2024-01-13",{"date":302,"type":22},"2027-06-30",{"name":40,"class":41},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":311,"minAge":19,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":329,"locationsCount":42},"100618704","phase-2-ctdna-in-her2-ebc-neoadjuvant-treatment-100618704","NCT07335081","ctDNA in HER2+ EBC Neoadjuvant Treatment","A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer","Inclusion Criteria:\n\n* histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \\>2cm)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography\n* No prior treatment\n\nExclusion Criteria:\n\n* Bilateral or metastatic breast cancer\n* History of other malignancies\n* Severe cardiovascular disease\n* Allergic to any of the regimens","FEMALE","70 Years",{"count":211,"type":22},[26],"This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy",[317],"Breast Cancer",[319,320,321,322],"Breast cancer","Neoadjuvant therapy","HER2 positive","ctDNA","2026-03-20",{"date":325,"type":34},"2026-03-24",{"date":327,"type":34},"2024-02-01",{"date":199,"type":22},{"name":40,"class":41},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":344,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"100630365","phase-1-aclarubicin-plus-with-azacitidine-and-venetoclax-in-the-treatment-of-acute-myeloid-leukemia-100630365","NCT07486726","Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia","A Multicenter, Open-Label, Phase 1\u002F2 Clinical Study of the Safety and Efficacy of Aclarubicin Combined With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form.\n2. Age 18 or above.\n3. Diagnosis (the diagnose is based on the 5th edition of the WHO classification of hematolymphoid tumors):\n\n   1. Phase I cohort: Adults ≥18 years with newly diagnosed AML who's not a candidate for intensive chemotherapy (criteria include age ≥75, significant cardiac\u002Fpulmonary\u002Fhepatic\u002Frenal comorbidities, CGA assessment unfit for IC, etc.) or declines.\n   2. Phase II cohort A: Adults ≥18 years with newly diagnosed AML who's not a candidate for intensive chemotherapy (criteria include age ≥75, significant cardiac\u002Fpulmonary\u002Fhepatic\u002Frenal comorbidities, CGA assessment unfit for IC, etc.) or declines.\n   3. Phase II cohort B: Adults ≥18 years with relapsed\u002Frefractory AML after intensive chemotherapy (Exclude patients with FLT3 or IDH1\u002F2 mutations who have not previously received targeted therapy).\n4. Performance status \\\u003C 3 (ECOG Scale).\n5. Estimated survival ≥ 3 months.\n6. White blood cell (WBC) count \\\u003C 25 × 10\\^9 cells\u002FL (hydroxyurea is permitted to control WBC count before treatment).\n7. Adequate liver and renal function as defined by the following criteria:\n\n   1. Total serum bilirubin \\\u003C 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI\n   2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 2.5 x ULN, unless due to the underlying leukemia approved by the PI\n   3. Creatinine clearance ≥50 mL\u002Fmin\n8. Ability to swallow\n9. Phase II Cohort B: Subjects have recovered from prior treatment toxicity to less than Grade 2 (per CTCAE v6.0), excluding the influence of the underlying disease. The following are excluded: alopecia, fatigue, hyperpigmentation, hypothyroidism stabilized with hormone replacement therapy, and peripheral neuropathy following chemotherapy.\n10. Phase II Cohort B: Washout period from first dose of prior anti-cancer therapy\n\n    1. at least 2 weeks after completion of cytotoxic chemotherapy\n    2. at least 5 half-lives for non-cytotoxic drugs (if the 5 half-lives exceed 4 weeks, the washout period will still be calculated as 4 weeks). If the half-life is unclear, a washout period of \\>4 weeks will be considered\n    3. at least 2 weeks after the first dose of anti-cancer traditional Chinese medicine.\n11. Subjects of reproductive potential must use effective contraceptive measures from the time they sign the informed consent form until 6 months after the last dose of the trial medication. Furthermore, male subjects of reproductive potential must refrain from sperm donation from the time they sign the informed consent form until 6 months after the last dose of the trial medication.\n\nExclusion Criteria:\n\n1. Prior therapies\n\n   1. Phase I cohort: Patients with prior therapy are not eligible. Patients with a history of myeloproliferative disorders (MPNs), including primary myelofibrosis (PMF), polycythemia vera (PV), chronic myeloid leukemia (CML) excluding essential thrombocythemia (ET); or myelodysplasia-myeloproliferative neoplasms (MDS-MPNs), including chronic monocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML), and acute promyelocytic leukemia (APL) are not eligible.\n\n      Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed.\n   2. Phase II cohort A: Same as for Phase I cohort.\n   3. Phase II cohort B: Patients relapsed\u002Frefractory to prior lower intensity therapy for AML are not eligible. No restriction on number of prior therapies.\n2. Patients suitable for and willing to receive intensive induction chemotherapy (for Phase I and Phase II cohort A).\n3. Congenital long QT syndrome or QTcF \\>450 msec (male), \\>470 msec (female). Repeat EKGs after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF \\>450\u002F470 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.\n4. Active serious infection not controlled by systemic antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).\n5. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.\n6. Active central nervous system leukemia, extramedullary AML (except liver\u002Fspleen\u002Flymph nodes)\n7. Known human immunodeficiency virus (HIV) seropositive. Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection.\n8. Patients who have received an allo-HCT within 60 days of first receiving study medication must discontinue all immunosuppressants during study treatment.\n9. Patients who have previously received CAR-T therapy.\n10. Subjects with malabsorption syndrome or other comorbidities that prevent them from swallowing capsules or taking medications via the enteral route.\n11. Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI.\n12. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) is permitted.\n13. Pregnant \u002Flactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 6 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 6 months after the last dose of study drugs.",{"count":21,"type":22},[25,26],"Acute myeloid leukemia Acute myeloid leukemia (AML) is a clonal hematopoietic cancer that disrupts normal hematopoiesis, ultimately leading to bone marrow failure and death. The annual incidence rate of AML is 4.1 per 100000 people in the US and is higher in patients older than 65 years. There has been a steady improvement in survival over the decades, more noticeably so in younger patients and in the last decade. Azacitidine and Venetoclax is now the standard treatment of newly diagnosed AML ineligible for intensive chemotherapy, while still facing the dilemma of relapse and refractory disease.\n\nAnthracycline-based chemotherapeutics were wildly used in the treatment of fit AML patients. While the cardiovascular toxicity leading to morbidity and mortality limited the use of daunorubicin\u002Fidarubicin in unfit patients. Aclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. CAG regimen, combined with low-dose cytarabine, aclarubicin and G-CSF has been widely used in China and Japan for treatment of AML.\n\nThe purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with azacitidine and venetoclax for subjects with newly diagnosed and relapsed \u002Frefractory AML.",[341,342,343],"Acute Myeloid Leukemia (AML)","Relapse Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia (AML)",[345,244,346,347],"acute myeloid leukemia","ineligible for intensive chemotherapy","Azacitidine and Venetoclax","2026-03-17",{"date":323,"type":34},{"date":351,"type":22},"2026-03-15",{"date":353,"type":22},"2028-10",{"name":40,"class":41},4,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":42},"100570270","phase-3-study-comparing-reduced-versus-standard-dose-post-transplantation-cyclophosphamide-in-combination-with-post-engraftment-anti-thymoglobin-as-graft-versus-host-disease-prophylaxis-in-alternative-donor-peripheral-stem-cell-transplantation-100570270","NCT06705062","Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation","A Multi-center Randomized Clinical Study Comparing Reduced-dose (35mg\u002Fkg) Versus Standard Dose (50mg\u002Fkg) Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin (ATG) and Tacrolimus and Post-engraftment Anti-thymoglobin as Graft Versus Host Disease (GVHD) Prophylaxis in Patients Undergo Alternative Donor Peripheral Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;\n2. normal organ function (creatinine clearance ≥ 50ml\u002Fmin\u002F1.73m2 or creatinine ≤2mg\u002Fd(or 177μmol\u002FL); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%);\n3. ECOG: 0-2;\n4. Life expectation ≥3 months;\n5. Informed consent provided.\n\nExclusion Criteria:\n\n1. Pregnancies\n2. active hepatitis (HBV-DNA≥1×103 copies\u002Fml);\n3. active infection require anti-biotics;\n4. HIV infection","55 Years",{"count":365,"type":22},316,[367],"PHASE3","This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg\u002Fkg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.",[370,371],"Allogeneic Hematopoietic Cell Transplant","Graft Versus Host Disease",[373,374,375,376],"post-transplantation cyclophosphamide","prophylaxis","reduced dose","graft versus host disease",{"date":348,"type":34},{"date":379,"type":34},"2025-01-01",{"date":381,"type":22},"2028-07-01",{"name":40,"class":41},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":363,"maxAge":186,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":400,"locationsCount":255},"100472797","phase-2-reduced-mbf-regimen-for-patients-55-years-with-myeloid-malignancies-100472797","NCT05436561","Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies","A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.","Inclusion Criteria:\n\n* Age 55-65\n* patients with HLA-matched sibling donors, 9-10\u002F10 matched unrelated donors or haplo-identical donors.\n* patients with AML in remission, or MDS in any stage, or CMML in any stage\n* inform consent provided\n\nExclusion Criteria:\n\n* patients with abnormal liver (\\>3N), renal (1.5N) or cardiac function\n* patients with active infection",{"count":391,"type":22},61,[26],"In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg\u002Fm2), busulfan (6.4mg\u002Fkg) and melphalan (100mg\u002Fm2) in patients with myeloid malignancies including AML, MDS and CMML \\>=55 years.",[395],"Disease-free Survival",{"date":348,"type":34},{"date":398,"type":34},"2022-06-01",{"date":302,"type":22},{"name":40,"class":41},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":408,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":4},"100624636","early-phase-1-safety-and-efficacy-of-es-nk-cell-injection-in-the-treatment-of-refractory-lupus-nephritis-an-early-clinical-study-100624636","NCT07412210","Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis: an Early Clinical Study","An Early Clinical Study to Evaluate the Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis","1. Must be \\>=5 years old and \\\u003C=35 years old at the time of informed consent;\n2. Diagnosed with SLE, with a renal biopsy within the past 24 months (for relapsed patients, biopsy must be after relapse) showing proliferative lupus nephritis (Class III or IV), or proliferative lupus nephritis with Class V (III\u002FIV + V), and still in a moderately to severely active state at screening;\n3. Either newly diagnosed or have shown poor response to current standard treatment after relapse;\n4. Positive for antinuclear antibodies (ANA), and positive for anti-dsDNA or anti-Sm antibodies;\n5. SLEDAI-2K score \\>=8;\n6. Urine protein\u002Fcreatinine ratio (UPCR) \\>=1.0 g\u002Fg (for those under 18 years old, urine protein quantification \\>=1.0 g\u002F24 h);\n7. (if applicable) Males and females with reproductive potential must use a highly effective contraceptive method or abstain continuously from the screening period until at least 1 year after the last dose, and must not donate sperm or eggs;\n8. The subject (if applicable) and their parents\u002Fguardians can understand the trial information, purpose, and risks as described in the informed consent form, and can authorize the use of the subject's health information, providing a signed and dated informed consent form;\n9. The subject (if applicable) and their parents\u002Fguardians are willing to participate as information providers in the study, providing the subject's health status, cognition, and physical capabilities (including information for grading scales);\n10. The subject (if applicable) and their parents\u002Fguardians (if applicable) are willing to participate as information providers in the study, providing the subject's health status, cognition, and physical capabilities (including information for grading scales).\n\nExclusion Criteria:\n\n1. SLE patients in lupus crisis, manifested by rapidly progressive lupus nephritis, diffuse alveolar hemorrhage, thrombotic microangiopathy, neuropsychiatric lupus, diffuse alveolar hemorrhage, pericardial tamponade, lupus mesenteric vascularization inflammation, catastrophic antiphospholipid antibody syndrome;\n2. Presence of uncontrolled active infection at the time of enrollment, or active viral infection of HBV, HCV or syphilis, etc., or positive HIV screening;\n3. Uncontrolled diabetes or hypertension, which is judged by the investigator to be unsuitable for immediate enrollment;\n4. Severe bone marrow dysfunction, severe hepatic cardiopulmonary dysfunction, or severe coagulation dysfunction;\n5. History of malignancy within the previous 5 years, with the exception of completely resected non-melanoma skin cancer, non-metastatic prostate cancer, and completely cured carcinoma in situ that have been stable for at least 6 months\n6. Those who are on renal dialysis or are expected to need dialysis during the trial;\n7. Receiving other systemic immunosuppressants other than SLE treatment (topical preparations for skin diseases can be used);\n8. Received B or T cell targeted therapy before screening, and the B or T cell level is still depleted;\n9. Previous organ or hematopoietic cell transplantation, or expected transplantation during the trial;\n10. Those who have received CAR-T cell therapy or gene therapy in the past;\n11. Immunization (live vaccine) within the week;\n12. eGFR\\\u003C=45ml\u002Fmin\u002Fm\\^2 at screening;\n13. Abnormal laboratory test indicators, including AST\\>=3×upper limit of normal (ULN), ALT\\>=3×ULN, TBIL\\>=3×ULN, creatinine\\>220umol\u002FL, ALT\u002FAST\\>5 times normal value, bilirubin \\>34umol\u002FL, neutrophil count \\\u003C1×10\\^9\u002FL, platelet count \\\u003C50×10\\^9\u002FL, hemoglobin \\\u003C80g\u002FL;\n14. There are other significant laboratory abnormalities and the investigator believes that the investigation is not suitable for immediate investigational drugs;\n15. Pregnant or lactating women;\n16. Contraindications to fludarabine or cyclophosphamide;\n17. Participated in other clinical studies of investigational drugs or devices within 3 months, or are still within 5 half-lives of clinical trial drugs;\n18. Presence of other concomitant serious diseases, conditions, or treatments that are assessed by the investigator to pose an unacceptable risk to the subject, or interfere with the subject's study compliance, or interfere with the conduct of the trial, or interfere with the evaluation of efficacy and safety.","5 Years","35 Years",{"count":411,"type":22},9,[413],"EARLY_PHASE1","This is a single-arm, open-label, dose-escalation clinical trial. The entire trial is preliminarily expected to enroll 5 to 9 subjects.\n\nThe initial plan is to explore three dose groups: 2.5×10⁷, 7.5×10⁷, and 2.5×10⁸ cells\u002Fkg, with 3 subjects in each group. During the trial, based on a comprehensive assessment by the Safety Review Committee (SRC), the dose, dosing frequency, or dosing interval may be adjusted or increased.\n\nIn the dose-escalation phase, for the same dose group, one subject will be enrolled first. After obtaining at least 4 weeks of safety data, and upon the investigator's assessment confirming that the safety and tolerability risks are controllable, the second and third subjects can be enrolled. If the efficacy and safety data of the first subject in a dose group, based on the investigator's comprehensive judgment, indicate a significantly insufficient pharmacological effect, the study may proceed directly to the next dose group.\n\nBefore proceeding to each subsequent dose group, the SRC must evaluate the safety and pharmacodynamic data from the previous dose group for at least 4 weeks. Enrollment for the next group can only begin after the SRC confirms that the safety and tolerability risks are controllable and that the next dose level remains appropriate. The dose escalation will be determined based on safety data, combined with pharmacodynamic and efficacy data.",[416],"Systemic Lupus Erythenlatosus Nephritis","2026-02-26",{"date":419,"type":34},"2026-03-02",{"date":421,"type":22},"2026-04",{"date":423,"type":22},"2029-03",{"name":40,"class":41},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":208,"maxAge":19,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100626275","early-phase-1-vgn-ex05e-in-patients-with-autism-spectrum-disorder-associated-with-severe-self-injurious-and-aggressive-behaviors-100626275","NCT07433517","VGN-Ex05e in Patients With Autism Spectrum Disorder Associated With Severe Self-Injurious and Aggressive Behaviors","An Early-Phase Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-Ex05e in Patients With Autism Spectrum Disorder (ASD) Associated With Severe, Treatment-Resistant Self-Injurious and Aggressive Behaviors","Inclusion Criteria:\n\n1. Male or Female, age \\>7, ≤18\n2. DSM-5 diagnosis of Autism Spectrum Disorder, confirmed by ADOS-2\n3. Diagnosis ≥ 2 years, with at least 6 months of unsuccessful systematic behavioral interventions or training, or those unable to undergo training;\n4. Target symptoms and severity: Presence of recurrent self-injurious or aggressive behaviors within the last 3 months, with at least one of the following documented (meeting at least one criterion): Any self-injury item on the RBS-R scoring ≥ 3; Self-injury\u002Faggression subscale of the BPI reaching one of the following criteria: frequency score ≥ 3, or severity score ≥ 3;\n5. Previous use of multiple medications (one or more antipsychotics and one or more mood stabilizers) with inadequate response, or those with severe adverse reactions, or those who cannot tolerate，and have discontinued medication for more than 5 half-lives or 1 month (whichever is longer) prior to screening, with the expectation that these medications will not be re-administered during the study period;\n6. Subjects\u002Fparents\u002Fguardians are able to understand the trial information, objectives, and risks as described in the informed consent form, are willing to comply with the clinical trial protocol, and can authorize the use of the subject's health information, voluntarily providing the signed and dated informed consent form;\n7. Subjects\u002Fparents\u002Fguardians are willing to act as information providers for the study, providing information on the subject's health status, cognitive, and physical abilities (including providing information for scales).\n8. Male and female subjects of childbearing potential must continuously and correctly use at least one highly effective method of contraception from the screening period through at least 1 year after administration.\n\nExclusion Criteria:\n\n1. Refractory epilepsy within the last 12 months prior to screening (≥2 seizures per month or status epilepticus), or significant EEG discharges during the screening period with a high-risk assessment;\n2. Co-occurring schizophrenia, bipolar disorder, or severe depressive disorder;\n3. Severe cardiac, hepatic, renal, or hematologic diseases;\n4. Coagulation disorders or bleeding tendencies (affecting surgical drug administration);\n5. Active infection at the time of screening, requiring systemic treatment;\n6. Co-occurring malignant tumors or history of tumors within the past 5 years；\n7. Positive HIV antibody, active hepatitis C infection, active hepatitis B infection, syphilis positive, or active tuberculosis at the time of screening;\n8. clinically significant abnormal ECG;\n9. Any of the following laboratory test indicators meet the following criteria (those who meet the criteria and have a clear reason for retesting can recheck and confirm within one week): 1) Hemoglobin count is below the detection limit, or thrombocytopenia (\\\u003C 100 × 10\\^9\u002FL); 2) Alanine aminotransferase ≥ 3 × ULN and\u002For Aspartate aminotransferase ≥ 3 × ULN and\u002For Total bilirubin ≥ 2 × ULN; 3) Those with renal function impairment, defined as eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2; 4) Myocardial enzyme spectrum (Creatine kinase CK and Creatine kinase isoenzyme CK-MB) \\> 3 × ULN; 5) Any laboratory abnormal value with significant clinical significance that other researchers consider may interfere with the efficacy and safety data analysis of this study.\n10. previous history of stem cell therapy or gene therapy;\n11. pregnant or lactating.\n12. Any history of intracranial infection or traumatic brain injury within 6 months prior to screening.\n13. MRI evidence of space-occupying lesions, arteriovenous malformations, active intracranial hemorrhage or infarction, diffuse cerebral atrophy, or severe developmental malformations.\n14. Prior intracranial surgical scarring that interferes with the planned trajectory to the nucleus accumbens (NAc).\n15. Participation in another clinical trial within 3 months prior to screening.\n16. History of severe hypersensitivity or allergic reactions to anesthetic agents or any components of the cell product.\n17. Presence of cranial metallic materials or implanted devices that contraindicate MRI, cause significant imaging artifacts affecting surgical navigation, or other conditions that preclude MRI examination.\n18. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the clinical trial.",{"count":72,"type":22},[413],"To evaluate the safety and tolerability of intracerebral injection of VGN-Ex05e in the nucleus accumbens of patients with autism spectrum disorder.",[436],"Autism Spectrum Disorder","2026-02-21",{"date":439,"type":34},"2026-02-25",{"date":421,"type":22},{"date":442,"type":22},"2027-10",{"name":40,"class":41},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":311,"minAge":19,"maxAge":312,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":42},"100623191","phase-2-neoadjuvant-trastuzumab-deruxtecan-shr-a1811--pertuzumab-in-her2-breast-cancer-100623191","NCT07393425","Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer","Neoadjuvant Therapy With Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab or Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab Sequenced With Paclitaxel-based Regimens + Trastuzumab + Pyrotinib in HER2+ Breast Cancer","Inclusion Criteria:\n\n* Age and Gender: Female patients aged ≥18 years and ≤70 years. Histological Confirmation: Patients must have histologically confirmed invasive breast cancer and must not have received any prior systemic anti-tumor therapy for breast cancer.\n* HER2 Positivity: Histologically confirmed HER2 receptor positivity, following the 2018 ASCO-CAP HER2 positivity judgment guidelines.\n\nConfirmed by pathology laboratory with immunohistochemistry (IHC) score of 3+, or 2+ with positive in situ hybridization (ISH) test (ISH amplification rate ≥2.0).\n\n* Tumor Stage: Patients must have tumor staging conforming to the Stage II-III breast cancer criteria according to the eighth edition of the AJCC breast cancer TNM staging system (T1\\~T4, N1\\~N3, M0).\n* Measurable Target Lesion: At least one measurable target lesion according to RECIST V1.1.\n* ECOG Performance Status: ECOG functional status score of 0\\~1.\n* Organ Function: Adequate organ function levels, with the following requirements (no blood transfusion or use of leukocyte or platelet elevation drugs within 2 weeks prior to screening):\n\n  * Hematology: Absolute neutrophil count (ANC) \\> 1.5 × 109\u002FL; Platelet count (PLT) \\> 75 × 109\u002FL; Hemoglobin (Hb) \\> 90 g\u002FL.\n  * Blood Chemistry: Total bilirubin (TBIL) \\\u003C 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 1.5 × ULN; Alkaline phosphatase \\\u003C 2.5 × ULN; Blood urea nitrogen\u002Furea (BUN\u002FUREA) and creatinine (Cr) \\\u003C 1.5 × ULN.\n  * Cardiac Ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%.\n  * 12-Lead ECG: Fridericia's method corrected QT interval (QTcF) \\\u003C 470 msec.\n* Reproductive Status: For premenopausal women with potential fertility, a pregnancy test must be performed within 7 days before treatment initiation, with negative serum\u002Furine pregnancy results.\n* Patients must not be lactating and must use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment completion.\n\nVoluntary Participation: Voluntary participation in the study with signed informed consent, good compliance, and willingness to cooperate with visit schedules and research-related procedures.\n\nExclusion Criteria:\n\n* Stage IV Breast Cancer: Patients with Stage IV breast cancer. Inflammatory Breast Cancer: Patients with inflammatory breast cancer. Prior Malignancy Treatment: Patients who have received prior anti-tumor therapy or radiotherapy for any malignancy, or have concurrent other malignancies, excluding cured cervical intraepithelial neoplasia, basal cell carcinoma, or squamous cell carcinoma.\n* Concurrent Anti-Tumor Therapy: Patients currently participating in other clinical trials involving anti-tumor therapy, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone modification therapy, or immune checkpoint inhibitor therapy.\n* Recent Surgery: Patients who have undergone major surgery unrelated to breast cancer within 4 weeks prior to the first dose of the study drug, or have not fully recovered from such surgery.\n* Serious Cardiac Disease: Patients with serious cardiac conditions, including but not limited to:\n* History of heart failure or systolic dysfunction (LVEF \\\u003C 50%). Uncontrolled high-risk arrhythmia, such as atrial tachycardia, resting heart rate \\> 100 bpm, significant ventricular arrhythmia, or advanced atrioventricular block (i.e., Mobitz II second-degree or third-degree atrioventricular block).\n* Angina pectoris requiring medication.\n* Clinically significant heart valve disease.\n* ECG showing transmural myocardial infarction.\n* Uncontrolled hypertension (after medication, systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg).\n* Uncontrolled Active Infection: Patients with uncontrolled active infection requiring treatment, or with a history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* Allergy to Study Drugs: Patients with a known history of allergy to any component of the study drugs.\n* Pregnant or Lactating Women: Pregnant or lactating women, women of childbearing potential with positive baseline pregnancy test, or those unwilling to use effective contraception during the trial period and for 6 months after the last dose of the study drug.\n* Interstitial Lung Disease: Patients with known or suspected interstitial lung disease; those with other severe pulmonary diseases that may interfere with drug-related pulmonary toxicity detection or management within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fobliterative bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive\u002Fobstructive lung disease, or any pulmonary autoimmune or inflammatory disease such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis; or those with a history of total pneumonectomy.\n* Severe Concomitant Diseases: Patients with severe concomitant diseases or other conditions that may interfere with the planned treatment, or those deemed unsuitable for the study by the investigator for any other reason.",{"count":452,"type":22},50,[26],"Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response\u002Fnear radiological complete response (rCR\u002Fnear rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery.\n\nIf cCR\u002FrCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.",[456],"HER2 + Breast Cancer",[458,459,460],"Trastuzumab Deruxtecan","SHR-A1811","neoadjuvant","2026-02-05",{"date":463,"type":34},"2026-02-06",{"date":465,"type":22},"2026-02-02",{"date":467,"type":22},"2032-09-30",{"name":40,"class":41},{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":312,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":488,"locationsCount":42},"100587574","phase-4-multi-center-randomized-controlled-clinical-study-of-shenling-baishu-granule-to-prevent-the-recurrence-of-low-risk-colorectal-adenoma-100587574","NCT06930157","Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma","Inclusion Criteria:\n\n* Meets the diagnostic criteria for low-risk colorectal adenoma.\n* Has undergone a colonoscopy of adequate quality (adequate bowel preparation, cecal intubation achieved, and withdrawal time ≥6 minutes) and received endoscopic minimally invasive polypectomy.\n* Within 3 months after adenoma resection.\n* 18-70 years of age; any sex.\n* Willing to participate and has voluntarily provided written informed consent.\n\nExclusion Criteria:\n\n* Incomplete adenoma resection.\n* Long-term use of aspirin, folic acid, calcium supplements, vitamin D, or similar agents.\n* Known hereditary polyposis syndromes (e.g., familial adenomatous polyposis) or hereditary colorectal cancer syndromes (e.g., Lynch syndrome\u002Fhereditary nonpolyposis colorectal cancer).\n* Colonoscopy findings strongly suggestive of inflammatory bowel disease.\n* History of malignancy within the past 5 years.\n* Pregnant or breastfeeding women, or participants with pregnancy potential who are planning pregnancy.\n* Severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, or diabetes mellitus.\n* Severe psychiatric disorders that would preclude cooperation with colonoscopy procedures.\n* Current condition preventing oral administration of the study drug (e.g., dysphagia, chronic diarrhea, intestinal obstruction).\n* Participation in another clinical study within the past 3 months or current participation in another clinical study.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.",{"count":476,"type":22},624,[478],"PHASE4","1. Complete a large-sample, multicenter, randomized blank-controlled clinical trial to evaluate Shenling Baizhu Granules for the prevention of colorectal adenoma recurrence.\n2. Generate high-level, internationally recognized clinical evidence to support the development of clinical practice guidelines for the prevention and treatment of colorectal adenoma using traditional Chinese medicine, and to strengthen the recommendation level of Shenling Baizhu Granules in clinical guidelines.\n3. Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.",[481],"Low-risk Colorectal Adenoma","2026-01-26",{"date":484,"type":34},"2026-01-28",{"date":486,"type":34},"2025-11-24",{"date":253,"type":22},{"name":40,"class":41},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":496,"maxAge":19,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":513,"leadSponsor":515,"locationsCount":42},"100621526","early-phase-1-cs-121-apoc3-base-editing-in-children-and-adolescents-with-hyperchylomicronemia-100621526","NCT07371767","CS-121 APOC3 Base Editing in Children and Adolescents With Hyperchylomicronemia","A Prospective, Single-center, Open-label, Single-arm Clinical Study to Evaluate the Safety and Efficacy of CS-121, an In Vivo Base Editing Therapy Delivered by Lipid Nanoparticles Targeting APOC3, in Children and Adolescents With Hyperchylomicronemia","Inclusion Criteria:\n\n* Male or female participants aged 4 years ≤ age \\\u003C 18 years.\n* Severe hypertriglyceridemia (sHTG), defined as a triglyceride (TG) level ≥ 500 mg\u002FdL.\n* Confirmed diagnosis of genetically inherited FCS via genetic testing, or clinically diagnosed FCS plus persistent chylomicronemia.\n* Failure to achieve adequate TG control, For participants under 8 years of age, the investigator determine at their discretion whether prior lipidlowering therapy has been administered.\n* Participants aged 6 years and above must sign the informed consent form themselves; for participants under 18 years of age, their parent\u002Flegal guardian must sign the informed consent form. (Participants under 6 years of age are exempt from signing the written informed consent form).\n* Female participants of childbearing potential must have a negative result on serum pregnancy testing.\n\nExclusion Criteria:\n\n* Currently participating in other interventional clinical studies, or having an insufficient washout period of less than 5 half-lives or 30 days (whichever is longer) since the last administration of other investigational drugs.\n* Used antisense oligonucleotide (ASO)-based or small interfering RNA (siRNA)-based lipid-lowering drugs targeting APOC3 within 3 months prior to study drug administration.\n* History of acute pancreatitis within 1 month before dosing.\n* Patients who underwent major surgery within 3 months prior to study drug administration and are judged by the investigator as unsuitable for receiving the study drug, due to potential intolerance to adverse events such as cytokine release storm.\n* ALT or AST ≥2 × ULN\n* Total bilirubin ≥1.5 × ULN\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* Random urine albumin-to-creatinine ratio (UACR) \\>30 mg\u002Fg, or urine protein is ≥ 2+\n* HbA1c ≥9%\n* Coagulation function abnormalities judged by the investigator as unsuitable for CS-121 administration.\n* Positive results for HBsAg, dual positivity for HCV antibody and RNA, positive for HIV, or positive for Treponema pallidum infection.\n* Known major organ diseases, mental disorders, Cushing's syndrome, hypothyroidism, history of lymphoproliferative disorders, or malignant tumors in any organ system, which are judged by the investigator as unsuitable for study participation due to potential intolerance to adverse events such as cytokine Release-Storm.\n* Concomitant medications\u002Ftreatments judged by the investigator to affect lipid metabolism, liver and kidney function, coagulation function, or interfere with the efficacy evaluation of the study drug.\n* Patients of childbearing potential who are planning pregnancy, breastfeeding, or have fertility plans.\n* History of hypersensitivity to any study drug, its excipients, or drugs of similar chemical classes.\n* Other medical conditions or comorbidities that, in the investigator's opinion, may interfere with study compliance or data interpretation.","4 Years",{"count":498,"type":22},15,[413],"This is a Prospective, Single-center, Open-label, Single-arm Clinical Study to Evaluate the Safety and Efficacy of CS-121, an In Vivo Base Editing Therapy Delivered by Lipid Nanoparticles Targeting APOC3, in Children and Adolescents (4-18 years) With Hyperchylomicronemia",[502],"Hyperchylomicronemia",[504,505,506,507,508,509],"Acute Pancreatitis","Apolipoprotein C3 (APOC3)","In Vivo Base Editing","Lipid Nanoparticles (LNP)","Gene Editing Therapy","Children and Adolescents","2026-01-19",{"date":484,"type":34},{"date":482,"type":22},{"date":514,"type":22},"2041-01-31",{"name":40,"class":41},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":186,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":42},"100621483","phase-2-multicenter-phase-ii-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-in-combination-with-kl-a167-for-neoadjuvant-treatment-of-triple-negative-breast-cancer-100621483","NCT07371208","Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer","ST-A-TN","Inclusion Criteria:\n\n* Age: 18-65 years old.\n* Diagnosis: Histologically and\u002For cytologically confirmed primary triple-negative breast cancer (TNBC) (excluding inflammatory breast cancer), meeting the criteria of tumor size ≥2 cm, clinical lymph node stage cN0 to cN3, and M0 (no distant metastasis). TNBC Definition: Immunohistochemistry (IHC) showing ER and PR \\\u003C10%; HER2-negative: IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH).\n* Tissue Sample: Availability of tumor tissue sample for biomarker testing.\n* Measurable Disease: At least one measurable lesion according to RECIST v1.1 criteria. Lesions previously irradiated cannot be selected as target lesions. Subjects with only skin lesions or bone lesions are excluded.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 within 7 days prior to treatment initiation.\n* Adequate Organ and Bone Marrow Function: Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count (PLT) ≥ 80 × 10⁹\u002FL; Hemoglobin ≥ 10 g\u002FdL. Liver Function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN. Renal Function: Creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula). Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 55% as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan.\n* Prior Treatment: No prior anti-tumor therapy for the current breast cancer.\n* Contraception: Female subjects must have a negative serum pregnancy test. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective medically approved contraceptive methods from the time of signing the informed consent form until 6 months after the last dose of study drug.\n* Informed Consent: Patients must voluntarily enroll in the study, provide written informed consent, and be able to comply with the protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n* Cardiovascular Disease: Baseline left ventricular ejection fraction (LVEF) \\\u003C 55% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or any other significant cardiovascular disease, or myocardial disease classified as New York Heart Association (NYHA) Class III or IV.\n* Prior Ipsilateral Breast Cancer: History of ipsilateral invasive breast cancer.\n* Prior Treatment for Current Breast Cancer: Any prior chemotherapy, targeted therapy, and\u002For radiotherapy for the currently diagnosed breast cancer prior to enrollment.\n* Prior Immune Checkpoint Inhibitor Therapy: Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n* Prior TROP2\u002FTopo I Inhibitor Therapy: Previous treatment with any TROP2-targeted therapy and\u002For topoisomerase I inhibitor.\n* Other Malignancies: History of other active malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.\n* Clinically Significant Pulmonary Impairment: Clinically significant pulmonary impairment due to concurrent pulmonary disease, including but not limited to: Any underlying pulmonary disease (e.g., pulmonary embolism within 3 months prior to treatment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) Any autoimmune, connective tissue, or inflammatory disease with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.)\n* History of pneumonectomy.\n* CYP3A4 Modulators: Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose or during the study period (Concomitant use of strong CYP3A4 inhibitors or inducers is prohibited in this study; representative agents are listed in Appendix 2). All subjects must avoid concomitant use of any known CYP3A4-inducing drugs, herbal supplements, and\u002For food.\n* Contraindications\u002FHistory: Known history of allergy\u002Fhypersensitivity to the study drugs or their components; history of immunodeficiency; history of organ transplantation.\n* Interstitial Lung Disease (ILD)\u002FPneumonitis: History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring systemic steroid therapy. Current ILD or non-infectious pneumonitis. Suspicious ILD or non-infectious pneumonitis on imaging at screening that cannot be ruled out by imaging evaluation.\n* Ocular Diseases: Documented severe dry eye syndrome, severe meibomian gland dysfunction and\u002For blepharitis, or history of corneal disease that may delay corneal epithelial healing.\n* Active Autoimmune Disease: Active autoimmune disease that has required systemic treatment within the past 2 years (Note: Hormone replacement therapy is not considered systemic treatment; e.g., type I diabetes, hypothyroidism managed with thyroid hormone replacement only, adrenal or pituitary insufficiency managed with physiologic corticosteroid replacement only).\n* Active Infection: Active infection requiring systemic therapy within 2 weeks prior to the first dose.\n* Uncontrolled Comorbidities: Any significant concurrent illness, in the investigator's judgment, that may jeopardize patient safety or affect study completion, including but not limited to uncontrolled hypertension, severe diabetes, active infection, etc.\n* Investigator Discretion: Any condition that, in the investigator's opinion, could interfere with the evaluation of the study drug, compromise patient safety, or interpretation of study results, or any other condition that makes the subject unsuitable for study participation.",{"count":524,"type":22},40,[26],"This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.",[317],[529,530,531,532,533,460],"breast cancer","triple negative","Sac-TMT","SKB264","KL-A167","2026-01-18",{"date":536,"type":34},"2026-01-27",{"date":538,"type":34},"2025-12-24",{"date":540,"type":22},"2030-08",{"name":40,"class":41},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":550,"maxAge":19,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":4},"100619856","phase-1-a-preliminary-clinical-study-on-the-efficacy-of-cyclophosphamide-and-sirolimus-combined-with-vic-1911-in-preventing-graft-versus-host-disease-after-haploidentical-stem-cell-transplantation-in-children-100619856","NCT07350057","A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children","Phase Ib Study on the Prevention of Graft-versus-host Disease (GVHD) in Children After Haploid Stem Cell Transplantation Using Cyclophosphamide (PTCy) Combined With Sirolimus and VIC-1911 Tablets","GVHD","Inclusion Criteria:\n\n* Participants must meet all of the following criteria in order to participate in this study:\n\n  1. Children aged 8-18, regardless of gender;\n  2. Prior to the start of the study, the subjects and their legal guardians shall sign a written informed consent form;\n  3. Patients diagnosed with the following blood diseases and deciding to undergo haplo HSCT:\n\n     1. Patients diagnosed with acute myeloid leukemia or high-risk acute lymphoblastic leukemia who have achieved complete remission (CR) through induction therapy;;\n     2. Patients diagnosed with myelodysplastic syndrome (MDS) and with an International Prognostic Scoring System (IPSS, please refer to Appendix 1a) score of medium risk 2 or high risk, or with severe blood cell reduction in the IPSS low-risk group, who have undergone ineffective treatment or have poor prognosis due to genetic abnormalities (such as -7,3q26 rearrangement, TP53 gene mutation, complex karyotype, monomeric karyotype);\n  4. There are peripheral blood stem cell donors who are 5\u002F10 HLA haploidentical;\n  5. Karnofsky (KPS) score (see Appendix 2) ≥ 80 points;\n  6. Possess sufficient organ functions, including:\n\n     1. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance rate (using Cockcroft Gault formula, please refer to Appendix 3) ≥ 50ml\u002Fmin;\n     2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are both ≤ 2 × ULN, and total bilirubin is\\\u003C1.5 × ULN (for subjects with Gilbert syndrome, inclusion should be determined by researchers and medical monitors);\n     3. Ferritin\\\u003C2000ng\u002Fml;\n     4. Adequate lung function, defined as FEV1, FVC, DLCO ≥ 50% of expected values; Pulmonary function test: FEV1, FVC, DLCO ≥ 50% of expected values;\n     5. Adequate cardiac function, defined as a left ventricular ejection fraction (LVEF) of ≥ 45% evaluated through echocardiography or multiple uptake gated acquisition (MUGA) scans;\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will be excluded from participating in this study:\n\n  1. Hematopoietic stem cell transplantation comorbidity index (HCT-CI)\\>4 (Sorror criteria, please refer to Appendix 5);\n  2. Plan to start post transplant maintenance treatment within 75 days after transplantation;\n  3. Those who are allergic to cyclophosphamide, VIC-1911 tablets, sirolimus, and sirolimus derivatives, or any excipient component of the above drugs;\n  4. Those who are unable or unwilling to discontinue other immunosuppressive treatments before the start of the study;\n  5. History of eye diseases, patients with central or branch retinal artery or vein occlusion, accompanied by significant visual impairment, or other retinal diseases determined by ophthalmologists leading to visual impairment;\n  6. Have a serious history of cardiovascular and cerebrovascular diseases, including but not limited to:\n\n     1. Hypertension that cannot be controlled after standard clinical treatment (systolic blood pressure\\>160mmHg or diastolic blood pressure\\>100mmHg for more than 4 weeks);\n     2. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc; According to the standards of the New York Heart Association (NYHA) in the United States (please refer to Appendix 6), patients with III-IV grade heart failure;\n     3. Within 6 months prior to the first administration, any of the following conditions have occurred: myocardial infarction, severe\u002Funstable angina, persistent arrhythmia with CTCAE v5.0 ≥ 2, atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass surgery, symptomatic congestive heart failure with CTCAE v5.0 ≥ 2, cerebrovascular accident (note: patients with lacunar cerebral infarction may be considered for inclusion);\n     4. Any factors that increase the risk of QTc interval prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, or the use of any known concomitant medication that may prolong the QT interval (see Appendix 7), except for antibiotics used for the prevention or treatment of infections;\n  7. Those who have undergone major surgical procedures within 28 days prior to administration, or those who are expected to undergo major surgery during the trial period;\n  8. During screening, there are clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of drugs (such as swallowing difficulties, uncontrollable nausea and vomiting, active gastric ulcers, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, etc.);\n  9. Have received the drug used in clinical trials or are currently participating in clinical trials involving the drug within 28 days before administration or within 5 half lives of the drug (whichever is longer);\n  10. People who have difficulty with venous blood collection;\n  11. Individuals who are positive for hepatitis B surface antigen (HBsAg) and\u002For core antibodies and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA), positive for hepatitis C virus (HCV) antibodies and positive for hepatitis C virus ribonucleotide (HCV RNA) testing, positive for Treponema pallidum antibodies, and positive for human immunodeficiency virus antibodies (HIV Ab) during screening;\n  12. Subjects who have used appropriate antibiotics or other treatments but still have uncontrolled systemic fungal, bacterial, viral, or other infections;\n  13. Have undergone major organ surgery (excluding aspiration biopsy) or severe trauma within 4 weeks prior to the first administration, or require elective surgery during the trial period;\n  14. The researchers believe that the patient is not suitable to participate in this study (such as not meeting the most beneficial treatment for the patient, patient compliance, etc.).","8 Years",{"count":411,"type":22},[25],"This study is a single arm, open label Phase Ib clinical trial, consisting of two parts: the first part is a safety introduction trial, and the second part is a dose escalation trial. In the first part, the tolerability, safety, PK characteristics, PD characteristics, and preliminary efficacy of VIC-1911 tablets in combination with PTCy and sirolimus will be explored. The first part will conduct safety introduction tests at the same dose as those already tested abroad to determine the dosage required for VIC-1911 tablets to meet safety and effective biological activity. The dose limiting toxicity (DLT) in Phase I study will be evaluated from the first administration of VIC-1911 tablets to 28 days after administration. On this basis, the second part of the experiment will be conducted to further explore the effectiveness and safety of VIC-1911 tablets combined with PTCy and sirolimus under RP2D for preventing GVHD in haplo HSCT patients after myeloablative pretreatment",[555],"GVHD (Acute or Chronic)","2026-01-16",{"date":558,"type":34},"2026-01-20",{"date":560,"type":22},"2026-03-25",{"date":562,"type":22},"2027-12-01",{"name":40,"class":41},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":255},"100620815","ai-assisted-real-time-endoscopic-characterization-of-diminutive-colorectal-polyps-in-non-academic-hospitals-100620815","NCT07362524","AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals","Artificial Intelligence-assisted Optical Diagnosis for the Resect-and-discard Strategy in Clinical Practice in Non-academic Hospitals: a Randomized Controlled Study","Inclusion Criteria:\n\n1. Agree to participate in this prospective randomized controlled study;\n2. Age ≥18 years for colonoscopy;\n3. At least one colorectal diminutive polyp (size \\\u003C=5mm) found during examination;\n\nExclusion Criteria:\n\n1. Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials;\n2. Already participating in drug clinical trials and being in the washout period of experimental or control drugs;\n3. History of drug or alcohol abuse or psychological disorders in the past five years;\n4. Pregnant or lactating patients;\n5. Known polyposis syndromes;\n6. Patients with gastrointestinal bleeding;\n7. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;\n8. Patients with contraindications to tissue biopsy;\n9. Previous history of allergic reactions to bowel cleansing agent components;\n10. Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.;\n11. Patient's bowel preparation BBPS score \\\u003C6 for this colonoscopy;\n12. Researchers consider the patient unsuitable for trial participation.",{"count":572,"type":22},363,[54],"To validate the feasibility of promoting colorectal diminutive polyp \"predict, resect, and discard\" and \"diagnose and leave\" strategies for non-experts in general hospitals through CADx system.",[576],"Colorectal Polyps","2026-01-15",{"date":579,"type":34},"2026-01-23",{"date":581,"type":22},"2026-02-15",{"date":583,"type":22},"2026-11-15",{"name":40,"class":41},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":312,"enrollmentInfo":591,"targetDuration":593,"studyType":82,"phases":4,"briefSummary":594,"conditions":595,"keywords":599,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":606},"100620874","standardized-implementation-and-quality-assessment-system-for-confocal-enteroscopy-100620874","NCT07363291","Standardized Implementation and Quality Assessment System for Confocal Enteroscopy","Inclusion Criteria:\n\n* Aged 18-70 years and scheduled to undergo small-bowel endoscopy.\n* Able to provide written informed consent and willing to participate in the study.\n* Certified gastroenterologists with an intermediate (or higher) professional title.\n\nHave completed formal training and passed competency assessments in gastroscopy, colonoscopy, and small-bowel endoscopy.\n\n-Willing to participate and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Poor general condition, severe hepatic or renal insufficiency, or inability to tolerate complete endoscopic examination.\n* Known hypersensitivity to any study-related agents (fluorescein sodium, polyethylene glycol, lidocaine mucilage).\n* Currently enrolled in another clinical trial.\n* Never perform endoscopic procedures.\n* Endoscopic procedure or image-reading volume \\\u003C 100 cases in the past 2 years.\n* Medical license revoked or currently suspended for any reason.",{"count":592,"type":22},600,"3 Years","Confocal technology, hailed as \"optical biopsy,\" enables real-time cellular-level histological examination of mucosal surfaces. Its integration with double-balloon enteroscopy significantly enhances the clinical feasibility of targeted biopsy, early diagnosis, and endoscopic staging for small bowel diseases such as inflammatory bowel disease. Currently, confocal endoscopy is primarily applied to upper and lower gastrointestinal tract diseases, leaving small bowel pathologies largely unexplored. Consequently, establishing a diagnostic framework for small bowel tumors and non-neoplastic lesions using confocal enteroscopy, alongside developing quality assessment standards for its operational procedures, is of paramount importance.",[596,597,598],"Confocal Enteroscopy","Quality Assessment System","Standardized Implementation",[596,598,597],{"date":579,"type":34},{"date":602,"type":34},"2025-06-01",{"date":604,"type":22},"2028-06-01",{"name":40,"class":41},8,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":106,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":626,"leadSponsor":628,"locationsCount":4},"100613800","a-clinical-study-to-evaluate-the-efficacy-and-safety-of-hyoscine-butylbromide-capsules-for-preoperative-preparation-in-painless-gastrointestinal-endoscopy-procedures-100613800","NCT07271303","A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures","A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years, regardless of sex;\n* Patients scheduled to undergo painless gastrointestinal endoscopy examination or endoscopic surgery, which must include upper gastrointestinal endoscopy;\n* Voluntary participation based on the free will of the subject or their legal guardian, with signed informed consent form.\n\nExclusion Criteria:\n\n* Patients with a history of upper gastrointestinal surgery or colorectal surgery;\n* American Society of Anesthesiologists (ASA) classification ≥ Grade III;\n* Patients with severe cardiac conditions, including severe arrhythmia, structural heart disease, or other serious cardiac disorders;\n* Significant hepatic or renal dysfunction affecting drug metabolism, defined as ALT \\> 2.5 × ULN, AST \\> 2.5 × ULN, or Scr \\> 1.5 × ULN;\n* Organic pyloric stenosis, paralytic ileus, or other severe organic gastrointestinal diseases that are unsuitable for painless gastrointestinal endoscopy;\n* Patients with suspected gastrointestinal ulcer bleeding or perforation;\n* Patients with glaucoma or prostatic hypertrophy;\n* Pregnant or lactating women;\n* Known hypersensitivity to any component of the study drug;\n* Use of medications affecting gastrointestinal motility within 7 days prior to study enrollment;\n* Other conditions unsuitable for painless endoscopy procedures;\n* Participation in another drug or medical device clinical trial within 30 days prior to study enrollment;\n* Patients deemed unsuitable for participation in this clinical study by the investigator.",{"count":615,"type":22},74,[54],"Gastrointestinal endoscopy procedures, including upper gastrointestinal endoscopy and colorectal endoscopy, represent a fundamental and important method for examining and managing digestive tract diseases, with both diagnostic and therapeutic applications. They are also utilized as effective tools for surveillance of gastrointestinal tumors. During upper gastrointestinal endoscopy procedures, gastric peristalsis may restrict the operative field of view and access, significantly affecting procedural precision. Excessive peristalsis not only affects the observation of simple lesions but also impacts other procedural maneuvers Therefore, during upper gastrointestinal endoscopy procedures, antispasmodic agents are commonly used to suppress gastrointestinal motility, ultimately facilitating endoscopic visualization. However, most antispasmodic agents, such as hyoscine butylbromide (Buscopan), cimetropium bromide (Algiron), and atropine, must be administered by injection. Intravenous or intramuscular administration causes patient pain and anxiety, and increases medical costs. Some researchers have taken an alternative approach by spraying L-menthol onto the gastric mucosa during gastroscopy to reduce gastric peristalsis. Although study results and adverse reaction profiles have demonstrated its superiority, the application process still presents operational inconveniences. Furthermore, these drugs should be used with caution as they may cause potential adverse reactions, including dry mouth, urinary retention, temporary impairment of visual accommodation, palpitations, anaphylactic shock, and hyperglycemia.",[619],"Painless Gastrointestinal Endoscopy",[621,622,623],"Painless gastrointestinal endoscopy","Hyoscine Butylbromide","Preoperative Preparation",{"date":558,"type":34},{"date":175,"type":22},{"date":627,"type":22},"2026-12-01",{"name":40,"class":41},""]