[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"First Affiliated Hospital of Zhejiang University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":640},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,105,0,25,[9,48,79,105,127,147,171,198,218,237,257,284,306,332,361,384,407,432,456,477,505,529,558,578,610],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":28,"conditions":29,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100625522","chrono-mobilize-chronotherapy-of-g-csf-for-cd34-mobilization-in-healthy-donors-100625522",false,"NCT07423728","CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors","Effect of Different Administration Timing of G-CSF on Peripheral Blood CD34+ Cell Mobilization in Healthy Donors: A Prospective Multicenter Randomized Controlled Trial","CHRONO-MOBILIZ","Inclusion Criteria:\n\n1. Age 18-55 years\n2. HLA matching appropriate for intended allo-HSCT recipient and meets donor medical evaluation criteria\n3. Body weight ≥35 kg and adequate blood volume\u002FBSA for apheresis\n4. Karnofsky score ≥80\n5. Screening labs meet thresholds (Hb\u002Fplatelets\u002FANC, liver\u002Frenal\u002Fcoagulation), no splenomegaly, pregnancy test negative if applicable\n6. Written informed consent\n7. Stable circadian rhythm before mobilization (no night shift\u002Fno ≥3 time-zone travel; avoid melatonin\u002Fsedatives or other agents affecting sleep\u002Fcircadian rhythm)\n\nExclusion Criteria:\n\n1. Prior\u002Fcurrent hematologic or immune diseases (e.g., aplastic anemia, leukemia, lymphoma, autoimmune disease)\n2. Significant cardiovascular\u002Fstructural heart disease, uncontrolled hypertension, uncontrolled diabetes\n3. Neurologic\u002Fpsychiatric disorders affecting adherence\n4. Sleep\u002Fcircadian disorders; recent night shift or ≥3 time-zone travel\n5. Prohibited medications (e.g., beta-blockers, systemic steroids \\>10 mg prednisone-equivalent ≥7 days, melatonin\u002Fpsychotropics; recent G-CSF\u002FGM-CSF\u002FCXCR4 inhibitor use)\n6. Severe allergy to G-CSF or components",true,"ALL","18 Years","55 Years",{"count":23,"type":24},160,"ESTIMATED","INTERVENTIONAL",[27],"NA","Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the efficiency of mobilization varies among donors, and suboptimal mobilization may require additional collection procedures or rescue strategies.\n\nThis prospective, multicenter, randomized trial evaluates whether the timing of daily G-CSF administration (morning vs evening) affects the level of circulating CD34+ cells prior to apheresis in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF 10 μg\u002Fkg once daily for 5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The primary endpoint is the peripheral blood CD34+ cell count measured approximately 12 hours after the last G-CSF dose and within 60 minutes before the start of the first apheresis session. Secondary endpoints include collection efficiency and CD34+ yield metrics, the proportion of donors achieving the target CD34+ dose on the first collection day, the need for a second collection day, and donor safety outcomes.\n\nThe goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures.",[30],"Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization",[32,33,34],"CD34","G-CSF","Allo-HSCT","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2026-03-01",{"date":43,"type":24},"2027-03-30",{"name":45,"class":46},"First Affiliated Hospital of Zhejiang University","OTHER",3,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":25,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100643970","phase-4-finerenone-for-regression-of-albuminuria-in-type-2-diabetes-with-chronic-kidney-disease-100643970","NCT07667517","Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease","Efficacy and Safety of Finerenone for the Early Regression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","Inclusion Criteria:\n\n* 1\\. Age \\>= 18 years at the time of signing informed consent, male or female.\n* 2\\. Type 2 diabetes mellitus.\n* 3\\. Chronic kidney disease meeting BOTH of the following: eGFR (CKD-EPI) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2, and UACR 30-2000 mg\u002Fg (mean of 3 measurements).\n* 4\\. Serum potassium \\\u003C= 5.0 mmol\u002FL.\n* 5\\. On a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days.\n* 6\\. Treatment with an SGLT-2 inhibitor, GLP-1 receptor agonist, or other agents affecting UACR is permitted, but the type and dose must be stable for at least 30 days before screening.\n\nExclusion Criteria:\n\n* 1\\. Type 1 diabetes, other specific types of diabetes, or gestational diabetes.\n* 2\\. HbA1c \\>= 8.0%.\n* 3\\. On renal replacement therapy.\n* 4\\. Acute kidney injury within 180 days before the screening visit.\n* 5\\. Hepatic impairment (Child-Pugh class C).\n* 6\\. Blood pressure \\> 160\u002F100 mmHg, or systolic blood pressure \\\u003C 90 mmHg, at the screening visit.\n* 7\\. Bilateral renal artery stenosis.\n* 8\\. Known hypersensitivity to the study drug (active substance or excipients).\n* 9\\. Treatment with finerenone within 60 days before screening.\n* 10\\. Stroke, transient ischemic attack, acute coronary syndrome (myocardial infarction, CABG, PCI), or hospitalization for worsening heart failure within 90 days before the screening visit.\n* 11\\. NYHA class II-IV heart failure.\n* 12\\. Addison's disease.\n* 13\\. Gastrointestinal surgery that may affect drug absorption.\n* 14\\. Any other history, condition, therapy, or uncontrolled concomitant disease that makes the participant unsuitable for the study or unlikely to complete it (e.g., active malignancy or other disease with life expectancy \\\u003C 12 months).\n* 15\\. Treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, nefazodone), a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort), or a moderate CYP3A4 inducer (e.g., efavirenz) that cannot be discontinued for at least 7 days before randomization.\n* 16\\. Treatment with another mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone, esaxerenone) or a potassium-sparing diuretic (e.g., amiloride, triamterene) that cannot be discontinued for at least 60 days before the screening visit.\n* 17\\. Biopsy-confirmed non-diabetic kidney disease (e.g., IgA nephropathy).\n* 18\\. Immunosuppressive therapy, or glucocorticoid use by any route other than topical or inhaled, within the past 180 days.\n* 19\\. Participation in another interventional clinical study or use of any investigational product within 90 days before randomization.\n* 20\\. History of alcohol or drug abuse.\n* 21\\. Women of childbearing potential who are pregnant, breastfeeding, intend to become pregnant, or are not using adequate contraception during the study.\n* 22\\. Any other condition deemed by the investigator to make the participant unsuitable for the study.",{"count":56,"type":24},148,[58],"PHASE4","This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 and UACR 30-2000 mg\u002Fg) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (\\\u003C300 vs \\>=300 mg\u002Fg), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.",[61,62,63],"Albuminuria","Type 2 Diabetes Mellitus (T2DM)","Chronic Kidney Diseases",[65,66,67,68,69],"Finerenone","Nonsteroidal mineralocorticoid receptor antagonist","Urine albumin-to-creatinine ratio","KDIGO","Albuminuria regression","NOT_YET_RECRUITING","2026-06-19",{"date":36,"type":39},{"date":74,"type":24},"2026-07-01",{"date":76,"type":24},"2027-12-31",{"name":45,"class":46},13,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":25,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100641596","phase-2-efficacy-and-mechanism-of-ipsrt-for-bipolar-ii-disorder-100641596","NCT07654348","Efficacy and Mechanism of IPSRT for Bipolar II Disorder","The Efficacy and Mechanism of Different Intervention Strategy for Bipolar II Disorder Patients With Rhythm Disturbance","Inclusion Criteria:\n\n* 1: a primary diagnosis of bipolar II disorder in accordance with DSM-V criteria, in a current major depressive episode;\n\n  2: scoring ≥17 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)\n\n  3: scoring \\\u003C12 on the Young Mania Rating Scale (YMRS)\n\n  4: medication-free (≥4 weeks without psychotropics)\n\n  5: with rhythm disturbance, scoring \\>26 on the Biological Rhythm Interview for Neuropsychiatry (BRIAN)\n\n  6: Understand written language and be able to conduct questionnaire survey\n\n  7: 18 to 60 years old, gender is not limited\n\n  8: the patient voluntarily participates, signs a written informed consent form, is willing to participate in the study and undergo evaluation\n\n  9: Han Chinese\n\n  10: Right-handedness\n\nExclusion Criteria:\n\n* 1: diseases that may significantly increase research risks or interfere with the evaluation of results\n\n  2: patients with rapid-cycling bipolar disorder (with \\>4 episodes within the past year);\n\n  3: any psychiatric or organic mental disorder, bipolar I disorder (BD I), current alcohol or drug dependence, borderline or antisocial personality disorder\n\n  4: patients currently receiving any psychological treatment or melatonin treatment intervention\n\n  5: patients with active suicidal ideation, HAMD-17 item 3 score ≥3\n\n  6: pregnant\n\n  7: patients with metal objects in the body (pacemaker, cochlear implant, implanted teeth, braces, metal foreign bodies, cardiac stent\u002Fintravascular coil, orthopedic steel plate, etc.) and other MRI examination contraindications (claustrophobia or inability to cooperate with the examination).","60 Years",{"count":88,"type":24},216,[90],"PHASE2","This project is based on the biphasic instability model and social timing theory, utilizing IPSRT to help regulate social interactions and establish regular daily habits, alleviate emotional symptoms, and prevent. The included patients with bipolar II disorder who did not take medication for the first time or relapsed within the past month were randomly divided into a medication only group (Q group), a only IPSRT group (I group). Group Q received treatment with quetiapine alone (starting at 50mg\u002Fday, with an additional 50mg to 300mg\u002Fday per week, and the dosage can be flexibly adjusted); Group I received 12 weeks of interpersonal and social rhythm therapy (12 sessions, once a week, 40 minutes each time, with relatively fixed tasks and agendas for each meeting). Compare the changes in various clinical evaluation scales and skin potential before and after treatment, explore the safety and effectiveness of drug therapy and psychotherapy for patients with bipolar II disorder with rhythm disorders, and investigate the potential biological mechanism of IPSRT by collecting data on salivary cortisol and melatonin, peripheral circadian rhythm genes (PER1\u002FPER2\u002FPER3\u002FBMAL1), and magnetic resonance.",[93],"Bipolar Disorder II",[95,96],"bipolar disorder II","interpersonal and social rhythm therapy","2026-06-12",{"date":99,"type":39},"2026-06-17",{"date":74,"type":24},{"date":102,"type":24},"2029-07-01",{"name":45,"class":46},1,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":25,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":104},"100643355","phase-1-healthy-participants-randomized-double-blind-placebo-controlled-phase--100643355","NCT07640438","Healthy Participants Randomized, Double-blind, Placebo-controlled, Phase Ⅰ","A Phase Ⅰ Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of BY002 in Healthy Participants","Inclusion Criteria:\n\n* 1\\. Male or female aged ≥18 years at the time of signing the Informed Consent Form (ICF).\n\n  2\\. At screening, body mass index (BMI) between 18 and 30 kg\u002Fm² (inclusive), with weight ≥50.0 kg for males and ≥45.0 kg for females.\n\n  3\\. Good health status determined by screening examinations. Good health status is defined as: absence of clinically relevant abnormalities or psychiatric diseases that, in the investigator's judgment, could compromise participant safety, affect the scientific validity of the study, expose the participant to unacceptable risk, or interfere with their compliance with study procedures and restrictions.\n\n  4\\. Male participants and their partners of childbearing potential must agree to use highly effective contraception during the study and for at least 12 weeks after the last dose. Male participants must refrain from donating sperm during this period. Female participants must not be pregnant or lactating. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and be willing to use highly effective contraception throughout the study and for at least 12 weeks after the last dose. Female participants must avoid donating eggs during this period.\n\n  5\\. Participants who, after capsaicin challenge during screening, meet the criteria specified in the Capsaicin Challenge Test Operating Manual (applicable only to participants undergoing the capsaicin challenge test).\n\n  6\\. Provide written informed consent before any study-related procedures are performed.\n\nExclusion Criteria:\n\n* 1\\. Individuals with a history or current presence of clinically significant cardiovascular (e.g., hypertension), pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatologic, psychiatric, systemic, ocular, reproductive, otorhinolaryngological, dermatological, or infectious diseases, or acute disease signs, unless deemed not clinically significant by the investigator and sponsor.\n\n  2\\. Individuals who have donated blood (≥400 mL) or experienced significant blood loss (≥400 mL), donated ≥2 units of blood components, or received a blood transfusion within 2 months prior to the first dose of investigational drug; or who plan to donate blood during the study.\n\n  3\\. Individuals with allergic constitution (defined as a clear history of allergy to two or more drugs, or to two or more common foods, or to common inhaled\u002Fcontact irritants such as pollen, dust mites, pet dander, mold, etc.), or a known history of allergic reactions to any therapeutic protein drugs (including monoclonal antibodies, fusion proteins, recombinant enzymes, cytokines, peptide hormones, blood products, vaccines, etc.).\n\n  4\\. Participants who are known to be allergic to any component of the investigational drug product or to capsaicin (applicable only to participants undergoing the capsaicin challenge test), or who have other contraindications.\n\n  5\\. Alcohol abuse or frequent alcohol consumption within 6 months prior to screening, defined as weekly alcohol intake exceeding 14 units (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), or unwillingness to abstain from alcohol and any alcohol-containing products during the study; or a positive alcohol breath test.\n\n  6\\. History of drug abuse within 12 months prior to screening, or positive urine drug screen result.\n\n  7\\. Smokers (defined as consuming more than 5 cigarettes or equivalent products per week), or those who cannot discontinue the use of any tobacco products during the study period.\n\n  8\\. The investigator determines that the participant's skin characteristics are unsuitable for capsaicin skin challenge (applicable only to participants undergoing the capsaicin challenge test).\n\n  9\\. Participants for whom venous blood collection is difficult.\n\n  10\\. Individuals who, as judged by the investigator, have clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), or chest X-ray at screening.\n\n  11\\. Individuals with a QT interval corrected using Fridericia's formula (QTcF) \\>450 ms for male participants or \\>470 ms for female participants on the screening electrocardiogram (ECG).\n\n  12\\. Positive result in any of the following tests: Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) antibody, anti-human immunodeficiency virus antibody (anti-HIV Ab), and specific antibody to Treponema pallidum (TP-Ab).\n\n  13\\. Individuals who have used any prescription medication, over-the-counter (OTC) drugs, traditional Chinese patent medicines, Chinese herbal medicines, vitamins, or dietary supplements within 14 days prior to the first dose or within 5 elimination half-lives or pharmacodynamic half-lives (whichever is longer) that may interfere with the study assessments.\n\n  14\\. Receipt of any vaccine within 2 weeks prior to the first dose of the investigational drug.\n\n  15\\. Individuals who have enrolled in or participated in any clinical trial containing investigational drugs or other medical research within 1 month prior to the first dose, or within 5 elimination half-lives (whichever is longer).\n\n  16\\. Individuals deemed by the investigator to be likely noncompliant during the study period, or unable to cooperate due to language barriers or intellectual disability, or otherwise unsuitable for participation in the trial.",{"count":113,"type":24},104,[115],"PHASE1","The objective of this clinical trial is to evaluate the safety and tolerability of BY002 in healthy subjects.\n\nInvestigators will compare BY002 to a placebo (a pharmacologically inactive substance) to assess the safety and tolerability of BY002 in healthy subjects.\n\nParticipants will undergo:\n\n1. Single\u002Fmultiple subcutaneous (SC) administrations of BY002\u002Fplacebo\n2. A 7-day safety follow-up period following the last dose",[118],"Healthy Participants Study","2026-06-05",{"date":121,"type":39},"2026-06-10",{"date":123,"type":39},"2026-06-01",{"date":125,"type":24},"2027-04-30",{"name":45,"class":46},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":25,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100643755","phase-1-a-clinical-study-evaluating-the-safety-tolerability-and-effect-on-hiv-reservoir-of-ibalizumab-combined-with-chidamide-a-histone-deacetylase-inhibitor-in-people-living-with-hiv-100643755","NCT07635992","A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIV","Inclusion Criteria:\n\n1. Subjects aged 18-65 years.\n2. Confirmed HIV infection by both initial screening assay and Western blot (WB) confirmatory test.\n3. Receiving a stable ART regimen for at least 6 months.\n4. Viral load below the lower limit of detection.\n5. CD4+ T-cell count \\>200 cells\u002Fmm³.\n6. Voluntarily signed the informed consent form and able to comply with regular follow-up visits, specimen collection, and monitoring\u002Ftreatment of study-related adverse events.\n7. Use effective contraception from 4 weeks prior to study initiation until 4 weeks after study completion.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study observation period.\n2. Subjects with poor treatment adherence.\n3. Receipt of immunosuppressants, other immunomodulatory agents, or cytotoxic drugs within 6 months prior to screening.\n4. Presence of severe underlying cardiac, cerebral, hepatic, renal, or other systemic diseases; neutrophil count \\\u003C1000\u002Fmm³; platelet count \\\u003C75,000\u002Fmm³; allergy to the investigational drug; or other contraindications to treatment.\n5. Presence of progressive (or active) malignancy, including but not limited to advanced, metastatic, or unresectable solid tumors or hematologic malignancies.\n6. Unwillingness to sign the informed consent form.","65 Years",{"count":135,"type":24},18,[115],"HIV viral reservoirs represent the major barrier to curing AIDS, and effectively reducing viral reservoirs in people living with HIV through different strategies has become a research priority in the HIV field.\n\nIpilimumab-tovorafenib monoclonal antibody injection (Aituo combination antibody, QL1706) contains two engineered monoclonal antibodies targeting PD-1 and CTLA-4. Chidamide is the first independently developed histone deacetylase inhibitor in China. This study aims to evaluate the safety and efficacy of Aituo combination antibody combined with chidamide in people living with HIV.\n\nThis study adopts a modified \"1+3+3\" dose-escalation design. Initially, one participant will be enrolled at dose level 1 (DL1) for safety observation. If the treatment is well tolerated, the study will proceed to a standard 3+3 design, with sequential dose escalation to DL2 and DL3.\n\nThree dose levels are planned: DL1, the starting dose, consists of ipilimumab-tovorafenib monoclonal antibody injection at 0.3 mg\u002Fkg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL2 consists of ipilimumab-tovorafenib monoclonal antibody injection at 1 mg\u002Fkg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL3 consists of ipilimumab-tovorafenib monoclonal antibody injection at 2 mg\u002Fkg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks.\n\nDuring dose escalation, progression to the next dose level or discontinuation of escalation will be determined according to the occurrence of dose-limiting toxicities (DLTs). The DLT observation window is 28 days after the first dose. Participants evaluable for DLT are those who complete the observation window or experience a DLT. After completion of dose escalation, the maximum tolerated dose (MTD) will be determined based on safety and tolerability. If the MTD is not reached, DL3 will be selected as the dose for subsequent study.\n\nAfter determination of the MTD or the subsequent study dose, an additional 11 participants will be enrolled at that dose level to further evaluate safety, tolerability, and preliminary efficacy. The maximum total sample size of the study will be 29 participants.",[139],"HIV (Human Immunodeficiency Virus)","2026-06-03",{"date":142,"type":39},"2026-06-09",{"date":123,"type":24},{"date":145,"type":24},"2028-12-31",{"name":45,"class":46},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":154,"enrollmentInfo":155,"targetDuration":157,"studyType":158,"phases":4,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":104},"100638998","effects-of-opioid-drugs-on-sleep-and-emotion-in-patients-with-moderate-to-severe-cancer-pain-100638998","NCT07616648","Effects of Opioid Drugs on Sleep and Emotion in Patients With Moderate to Severe Cancer Pain","Clinical Study on the Effects of Opioid Drugs on Sleep and Mood in Patients With Moderate to Severe Cancer Pain","Inclusion Criteria:\n\n1. Aged 18-75 years.\n2. Histopathologically or cytologically confirmed diagnosis of malignancy, with moderate to severe cancer-related pain (NRS ≥ 4 points), meeting the WHO three-step analgesic ladder principle, having received opioid analgesic therapy for at least one week with a stable dose and well-controlled pain.\n3. ECOG performance status score ≤ 3.\n4. Possess basic cognitive function and ability to complete questionnaire-based assessments and wristband-based sleep monitoring.\n5. Voluntarily sign the informed consent form and agree to comply with the study follow-up procedures.\n\nExclusion Criteria:\n\n1. Severe cognitive impairment, history of psychiatric disorder, or language\u002Fcommunication barriers that precludes completion of the assessments.\n2. History of opioid abuse or dependence; history of alcohol or non-opioid substance abuse.\n3. Severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR \\\u003C 30 mL\u002Fmin).\n4. Life expectancy \\\u003C 3 months.\n5. Women of childbearing age without effective contraception, or who are pregnant or breastfeeding.\n6. Presence of other serious diseases or special conditions that, in the investigator's judgment, may interfere with the study outcomes.\n7. Presence of contraindications to the study drug, such as paralytic ileus, chronic obstructive respiratory disease, or cor pulmonale.","75 Years",{"count":156,"type":24},200,"3 Months","OBSERVATIONAL","This study is a multicenter cross-sectional observational study, aiming to include approximately 200 patients aged 18-75 years who are using hydrocodone sustained-release tablets or oxycodone sustained-release tablets for pain management of moderate to severe cancer pain. Baseline information, tumor history, and comorbidities of the subjects will be collected through electronic patient-reported outcomes (ePRO), and the pain condition will be evaluated using BPI, acute pain assessment tools, etc. Sleep-related indicators will be collected using Huawei smart wearable devices and PSQI, ISI scales. Psychological emotional states will be assessed using NCCN psychological distress thermometer, HAMA, HAMD, etc. Blood samples will also be collected for relevant tests. The study sets up a screening baseline assessment period, a 1-week assessment period, and 1-month and 3-month follow-up periods after enrollment. The changes in relevant indicators will be tracked throughout the process, aiming to quantify the association between pain and insomnia, anxiety and depression, and to verify the potential mediating role of sleep disorders between pain and emotional disorders, providing a basis for optimizing the comprehensive symptom management of cancer pain patients.",[161],"Moderate to Severe Cancer Pain",[163],"cancer pain","2026-05-27",{"date":123,"type":39},{"date":167,"type":39},"2026-04-15",{"date":169,"type":24},"2028-03-15",{"name":45,"class":46},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":154,"enrollmentInfo":178,"targetDuration":4,"studyType":25,"phases":180,"briefSummary":181,"conditions":182,"keywords":186,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":104},"100639523","phase-2-tafolecimab-combined-with-sintilimab-and-sox-in-the-treatment-of-pmmrmss-gastric-cancer-100639523","NCT07621562","Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR\u002FMSS Gastric Cancer","Efficacy and Safety of a PCSK9 Inhibitor (Tafolecimab) Combined With Sintilimab and SOX in the Treatment of pMMR\u002FMSS Gastric Cancer: A Multicenter, Prospective, Single-Arm Exploratory Study","Inclusion Criteria:\n\n1. Fully understood the study and voluntarily signed the Informed Consent Form (ICF);\n2. Aged 18-75 years, male or female;\n3. Histopathologically confirmed pMMR\u002FMSS type gastric\u002Fgastroesophageal junction adenocarcinoma;\n4. Initially unresectable, advanced gastric\u002Fgastroesophageal junction adenocarcinoma;\n5. ECOG performance status 0-1;\n6. Life expectancy exceeding 3 months;\n7. Presence of measurable disease as confirmed by the investigator according to RECIST 1.1 criteria;\n8. Patients currently taking statin lipid-lowering medications must discontinue for ≥4 days before enrollment in this study;\n9. Adequate major organ function meeting the following requirements (laboratory values must meet the following criteria within 7 days before enrollment):\n\n   * Hematology (no transfusion, no granulocyte colony-stimulating factor \\[G-CSF\\], no medication correction within 14 days before screening):\n   * Neutrophils ≥ 1.5 × 10⁹\u002FL;\n   * Platelets ≥ 75 × 10⁹\u002FL;\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Biochemistry (no albumin infusion within 14 days before screening):\n   * Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance \\> 50 mL\u002Fmin;\n   * Serum total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's syndrome are allowed total bilirubin ≤ 3 × ULN);\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with liver metastases, ALT and AST ≤ 5 × ULN;\n\n   Coagulation function:\n\n   \\- International Normalized Ratio (INR) ≤ 2.3 or Prothrombin Time (PT) exceeding normal control by ≤ 6 seconds;\n10. No severe concomitant diseases leading to a life expectancy \\\u003C 5 years;\n11. Agree to provide blood and tissue samples for molecular biology testing;\n12. For patients with active Hepatitis B Virus (HBV) infection: HBV-DNA must be \\\u003C 500 IU\u002FmL (if the study center only uses copy\u002FmL units, must be \\\u003C 2500 copies\u002FmL), and willing to receive antiviral therapy throughout the study period; Hepatitis C Virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines and have liver function elevations within CTCAE Grade 1;\n13. Within 28 days before enrollment, females of childbearing potential must have a confirmed negative serum pregnancy test and agree to use effective contraception during study drug administration and for 60 days after the last dose. For this protocol, females of childbearing potential are defined as sexually mature women who: 1) have not undergone hysterectomy or bilateral oophorectomy; 2) have not been naturally postmenopausal for at least 24 consecutive months (cancer treatment-induced amenorrhea does not rule out childbearing potential) (i.e., have had menstruation at any time in the preceding 24 consecutive months). Male subjects' female partners of childbearing potential should also follow the above contraceptive requirements.\n\nExclusion Criteria:\n\n1. HER2 positive (IHC 3+, or IHC 2+ with positive in situ hybridization);\n2. EBER positive;\n3. CLDN18.2 positive (≥ 75% of tumor cells with membranous staining of IHC intensity 2+\u002F3+);\n4. Currently participating in other interventional clinical studies;\n5. Low-density lipoprotein cholesterol (LDL-C) controlled below 30 mg\u002FdL (≈ 0.78 mmol\u002FL);\n6. History of allergic reaction to PCSK9 inhibitors;\n7. Concurrent other active malignancy within the last 5 years besides gastric\u002Fgastroesophageal junction adenocarcinoma that has not recovered; Patients preparing for or having previously received organ or allogeneic bone marrow transplantation;\n8. Received major surgery (excluding diagnostic) within 4 weeks before start of study treatment or expected to require major surgery during the study (excluding radical gastrectomy);\n9. Currently have interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that might interfere with the judgment and management of immune-related pulmonary toxicity, or evidence of active pneumonitis on chest computed tomography (CT) scan during the screening period, or severely impaired pulmonary function.Subjects with radiation pneumonitis in the radiation field are allowed; active tuberculosis;\n\n11\\. Presence of active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects controlled by hormone replacement therapy alone can be included\\]); subjects with skin diseases not requiring systemic treatment such as vitiligo, psoriasis, alopecia, controlled Type I diabetes mellitus receiving insulin therapy, or childhood asthma that has completely resolved and requires no intervention in adulthood can be included; asthma patients requiring bronchodilators for medical intervention cannot be included; 12. History of uncontrolled epilepsy, central nervous system disease, or mental disorders, judged by the investigator as to whether clinical severity interferes with signing informed consent or affects patient compliance with medication; 13. Clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or more severe congestive heart failure, or severe arrhythmia requiring medical intervention, or history of myocardial infarction within the last 12 months; 14. Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; 15. Allergy or contraindication to the components of the study drugs (PCSK9 inhibitor, PD-1 monoclonal antibody, or chemotherapeutic agents); 16. Prior receipt of any anti-tumor therapy for gastric\u002Fgastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, systemic therapy, etc.; 17. Use of immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \\> 10 mg\u002Fday prednisone or equivalent) within 14 days before the start of study treatment; 18. Patients with congenital or acquired immunodeficiency (e.g., HIV infection); 19. Co-infection with Hepatitis B and Hepatitis C; 20. Prior receipt of other anti-PD-1 antibody therapy or other immunotherapy targeting PD-1\u002FPD-L1, or prior receipt of PCSK9 monoclonal antibody therapy; 21. Receipt of live attenuated vaccine within 28 days before start of study treatment, or expected need for such vaccination during PD-1 monoclonal antibody treatment or within 60 days after the last dose of PD-1 monoclonal antibody; 22. Receipt of investigational drug (i.e., participating in another trial), anti-tumor cytotoxic drug therapy, biological drug therapy (e.g., monoclonal antibodies), immunotherapy (e.g., interleukin-2 or interferon) within 4 weeks before study enrollment; 23. Judged by the investigator, patients have other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring concurrent treatment, severe laboratory abnormalities, family or social factors, etc., that might affect subject safety or compliance; 24. Subjects with active tuberculosis (TB), receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year before screening; 25. Pregnant or breastfeeding women.",{"count":179,"type":24},30,[90],"Background:\n\nGastric cancer remains a significant health burden globally, particularly in China, where the majority of patients present with advanced disease at diagnosis. While immune checkpoint inhibitors (ICIs) targeting PD-1 have revolutionized treatment for various malignancies, their efficacy in proficient mismatch repair (pMMR) or microsatellite stable (MSS) gastric cancer-which constitutes over 85% of cases-remains limited. Recent Phase III trials (CheckMate 649, ATTRACTION-04, Orient-16) have demonstrated that combining PD-1 inhibitors with chemotherapy improves outcomes in advanced gastric cancer, leading to approved indications. However, the benefit in pMMR\u002FMSS populations is modest, highlighting an urgent need for novel combination strategies to overcome immunotherapy resistance.\n\nPreclinical research published in Nature (Liu et al., 2020) revealed that inhibiting PCSK9 (Proprotein Convertase Subtilisin\u002FKexin type 9)-a key regulator of cholesterol metabolism-can potentiate immune checkpoint therapy through a novel mechanism independent of its lipid-lowering function. PCSK9 inhibition was shown to increase tumor cell surface expression of MHC class I molecules by preventing their lysosomal degradation, thereby enhancing tumor antigen presentation and promoting cytotoxic T lymphocyte infiltration. This mechanistic insight suggests that combining a PCSK9 inhibitor with PD-1 blockade could synergistically improve antitumor immunity, particularly in immunologically \"cold\" tumors like pMMR\u002FMSS gastric cancer.\n\nTafolecimab is the first domestically developed fully humanized PCSK9 monoclonal antibody approved in China for hypercholesterolemia, with a favorable safety profile and extended half-life. Based on this strong preclinical rationale and the established efficacy of PD-1 plus chemotherapy in gastric cancer, this investigator-initiated trial aims to clinically translate the concept of PCSK9 inhibition as an immunomodulatory strategy.\n\nStudy Population:\n\nThis study will enroll 30 patients with the following key eligibility criteria:\n\nInclusion: Adults aged 18-75 years with histologically confirmed pMMR\u002FMSS gastric or gastroesophageal junction adenocarcinoma; initially unresectable or advanced disease (including metastatic); ECOG performance status 0-1; measurable disease per RECIST v1.1; adequate organ function.\n\nExclusion: HER2-positive, EBER-positive, or CLDN18.2-positive tumors; prior systemic anticancer therapy for advanced disease; active autoimmune disease requiring immunosuppression; uncontrolled intercurrent illness; LDL-C \\\u003C30 mg\u002FdL; history of PCSK9 inhibitor allergy; prior exposure to anti-PD-1\u002FPD-L1 or PCSK9-targeted therapies.\n\nStudy Objectives:\n\nThis is a multicenter, prospective, single-arm exploratory trial with a safety run-in phase (first 6 patients monitored for dose-limiting toxicities). The treatment regimen consists of:\n\nSintilimab (PD-1 inhibitor): 200 mg IV, day 1, every 3 weeks (Q3W) Tafolecimab (PCSK9 inhibitor): 300 mg subcutaneous injection, day 1, Q3W (dose reduction to 150 mg if DLTs occur) SOX chemotherapy: Oxaliplatin 130 mg\u002Fm² IV, day 1 + S-1 40 mg\u002Fm² orally twice daily, days 1-14, Q3W cycles Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.\n\nPrimary Endpoint:\n\nObjective Response Rate (ORR) assessed by RECIST v1.1\n\nSecondary Endpoints:\n\nProgression-Free Survival (PFS) Disease Control Rate (DCR) Conversion surgery rate and R0 resection rate Pathological Complete Response (pCR) and Major Pathological Response (MPR) rates in resected patients Overall Survival (OS) Safety and tolerability (incidence of TRAEs, ≥Grade 3 AEs, irAEs per CTCAE v5.0)\n\nExploratory Endpoints:\n\nAssociation between tumor biomarkers (including PD-L1 CPS, H. pylori infection status, and tumor PCSK9 expression) and treatment efficacy Multi-omics analyses using paired pre- and post-treatment tumor tissue, peripheral blood, and fecal samples\n\nSample Size and Duration:\n\nA fixed sample size of 30 patients will be recruited over approximately 12 months, with survival follow-up extending to 36 months. This exploratory study is designed to generate preliminary efficacy and safety signals to inform future larger-scale investigations. The safety run-in design ensures close monitoring for potential additive toxicities, particularly given the novel combination of PCSK9 inhibition with immunotherapy and chemotherapy.",[183,184,185],"Gastric Adenocarcinoma","Esophagogastric Juction Cancer","Proficient Mismatch Repair",[187,188,189,190,191],"Gastric adenocarcinoma","Esophagogastric junction cancer","Proficient mismatch repair","Tafolecimab","Sintilimab",{"date":193,"type":39},"2026-06-02",{"date":119,"type":24},{"date":196,"type":24},"2030-09-01",{"name":45,"class":46},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":25,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":104},"100594596","efficacy-and-safety-assessment-of-temporal-interference-stimulation-to-improve-bipolar-depression-100594596","NCT07021508","Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression","Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression: a Randomized Controlled Study","Inclusion Criteria:\n\n* right-handed, and have completed nine years of compulsory education;\n* Meet the diagnostic criteria for bipolar depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);\n* ≥18 points on the Hamilton Depression Inventory (HAMD- 17);\n* ≤8 points on the Young's Mania Rating Scale (YMRS);\n* Subjects who have not been treated with psychiatric medication, or those who have been treated with medication are required to undergo medication washout within 2 weeks before randomization;\n* Subjects\u002Flegal guardians are willing to cooperate with the treatment and sign an informed consent form after they have fully understood the Temporal Interference Stimulation (TI).\n\nExclusion Criteria:\n\n* Contraindications to magnetic resonance scanning (MRI) or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);\n* Prior or current electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), transcranial direct current therapy (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation;\n* Pregnant and lactating women, and women of childbearing age with a positive urine pregnancy;\n* Possesses a diagnosis of another major psychiatric disorder that has been assessed by the study investigator as a major disorder that results in more impairment than a diagnosis of bipolar disorder;\n* Co-morbid other psychiatric disorders, including obsessive-compulsive disorder, personality disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.; Has active suicidal ideation (≥ 4 points on item 10 of the MADRS);\n* Risk of serious injury to self or others;\n* History of serious physical illness or disease that may affect the central nervous system;\n* Risk of neurologic disorders or seizures, such as previous craniosynostosis, cranial trauma, abnormal electroencephalograms, magnetic resonance evidence of structural abnormalities of the brain, or family history of epilepsy.","45 Years",{"count":23,"type":24},[27],"The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the corresponding neuroimaging mechanisms using magnetic resonance and electroencephalogram to provide novel intervention protocols and objective indicators of efficacy prediction for depressive episodes in bipolar disorder.",[210],"Bipolar Depression","2026-05-25",{"date":164,"type":39},{"date":214,"type":39},"2025-05-20",{"date":216,"type":24},"2026-12",{"name":45,"class":46},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":25,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":104},"100579605","the-efficacy-and-safety-of-task-state-based-temporal-interference-stimulation-ti-in-the-treatment-of-patients-with-depression-100579605","NCT06826469","The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression","Inclusion Criteria:\n\n1. Aged 18-50 years old, right-handed, and completed nine years of compulsory education;\n2. Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression;\n3. HAMD-17≥18;\n4. Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks;\n5. The subject\u002F legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (TI).\n\nExclusion Criteria:\n\n1. Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;\n2. Severe suicidal ideation or behavior;\n3. History of a serious physical illness or a disease that may affect the central nervous system;\n4. Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;\n5. Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);\n6. Those who have received or are receiving electroconvulsive therapy (ECT ), modified electroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments;\n7. Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.","50 Years",{"count":226,"type":24},43,[27],"This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.",[230],"Major Depressive Disorder",{"date":164,"type":39},{"date":233,"type":24},"2026-06",{"date":235,"type":24},"2027-06",{"name":45,"class":46},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":205,"enrollmentInfo":244,"targetDuration":4,"studyType":25,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":104},"100638963","research-on-the-efficacy-and-safety-of-targeted-suprachiasmatic-nucleus-electrical-stimulation-for-improving-metabolic-disorders-in-patients-with-stable-bipolar-disorder-comorbid-with-obesity-100638963","NCT07589647","Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disorder Comorbid With Obesity","Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disordercomorbid With Obesity","Inclusion Criteria:\n\n1. Both biological parents are of Han ethnicity;\n2. Age range: 18 to 45 years old, gender not restricted;\n3. Meets the clinical diagnostic criteria for bipolar disorder as stipulated in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);\n4. Body Mass Index (BMI) ≥ 28 kg\u002Fm2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm;\n5. HAMD-24 score \\\u003C 7 points, YMRS score \\\u003C 5 points;\n6. All included researchers and their family members have given informed consent for this study.\n\nExclusion Criteria:\n\n221\u002F5000\n\n1. Individuals with other DSM-5 spectrum disorders;\n2. Mental disorders caused by substance abuse (such as alcohol, drugs, etc.), and those with severe physical illnesses;\n3. Those who consumed food or microecological preparations containing probiotics, prebiotics, etc. within one week before enrollment, and had a history of respiratory, urinary, digestive system infections and antibiotic use within one month before enrollment;\n4. Those currently having serious suicidal thoughts or behaviors, or those with severe agitation;\n5. Those who cannot follow medical advice for treatment, or those without guardians;\n6. Pregnant or lactating women, or those planning to become pregnant;\n7. Those who cannot complete MRI examinations due to special conditions such as having metal implants or pacemakers in their bodies.",{"count":245,"type":24},70,[27],"This study aims to stabilize the patients with bipolar disorder (BD) comorbid with obesity in the stable phase by using temporal interference stimulation (TIS ) intervention. It intends to investigate the changes in key metabolic molecules such as GLP-1 circadian rhythm, and further explore the molecular mechanism of their metabolic disorders.",[249],"Bipolar Disorder (BD)","2026-05-24",{"date":164,"type":39},{"date":253,"type":39},"2026-04-27",{"date":255,"type":24},"2027-03-31",{"name":45,"class":46},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":86,"enrollmentInfo":264,"targetDuration":4,"studyType":25,"phases":266,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":283,"locationsCount":4},"100634246","inulin-spirulina-co-intervention-for-insomnia-disorder-100634246","NCT07537192","Inulin-Spirulina Co-intervention for Insomnia Disorder","Investigation of the Therapeutic Efficacy and Mechanistic Pathways of Inulin-Spirulina Co-intervention in Patients With Insomnia Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 to 60 years;\n2. Meet the ICSD-3 diagnostic criteria for chronic insomnia disorder;\n3. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5;\n4. Willing to participate and provide written informed consent.\n\nExclusion Criteria:\n\n1. Use of prebiotics, probiotics, high-fiber supplements, or microbiota-related products within the past 8 weeks;\n2. Diagnosis of psychiatric disorders other than insomnia based on DSM-5 criteria, assessed using the Mini-International Neuropsychiatric Interview (MINI);\n3. Regular use of sedative or hypnotic medications within the past 4 weeks, or frequent intermittent use (e.g., benzodiazepines, non-benzodiazepine receptor agonists, melatonin receptor agonists, sedating antihistamines);\n4. Severe hepatic or renal dysfunction, hematologic disorders, or respiratory diseases;\n5. Severe gastrointestinal diseases or malnutrition;\n6. Pregnancy or breastfeeding;\n7. Apnea-hypopnea index \\> 10, or periodic limb movement index \\> 15\u002Fhour on polysomnography;\n8. Known allergy or intolerance to inulin, spirulina, or maltodextrin;\n9. Participation in another clinical trial within the past 3 months.",{"count":265,"type":24},180,[27],"The goal of this clinical trial is to learn if inulin and spirulina, used alone or in combination, can improve insomnia disorder in adults aged 18 to 60 years with chronic insomnia disorder. It will also learn about the safety of these interventions. The main questions it aims to answer are:\n\nDoes inulin plus spirulina improve sleep quality, as measured by the reduction rate in Pittsburgh Sleep Quality Index (PSQI) score? Does the intervention improve sleep-related, mood, anxiety, and cognitive outcomes after 12 weeks? Researchers will compare an inulin group, a spirulina group, a combined inulin plus spirulina group, and a placebo group to see if the combined intervention provides greater benefit than either single intervention or placebo.\n\nParticipants will:\n\nbe randomly assigned to 1 of 4 groups: inulin, spirulina, inulin plus spirulina, or placebo; take the assigned study product once daily for 12 weeks; complete sleep, mood, anxiety, and cognitive assessments at baseline and week 12; undergo polysomnography and provide blood and stool samples at baseline and week 12; and be monitored for adverse events throughout the study.",[269,270],"Insomnia Disorder","Sleep Initiation and Maintenance Disorders",[272,273,274,275,276],"Inulin","Spirulina","Gut Microbiota","Gut-Brain Axis","Insomnia","2026-05-15",{"date":279,"type":39},"2026-05-19",{"date":281,"type":24},"2026-05-01",{"date":125,"type":24},{"name":45,"class":46},{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":133,"enrollmentInfo":290,"targetDuration":4,"studyType":25,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":303,"leadSponsor":305,"locationsCount":104},"100640404","phase-1-a-safety-and-efficacy-trial-of-chidamide-combined-with-nkg2d-car-nk-cell-therapy-for-reducing-the-hiv-viral-reservoir-100640404","NCT07577986","A Safety and Efficacy Trial of Chidamide Combined With NKG2D CAR-NK Cell Therapy for Reducing the HIV Viral Reservoir","Inclusion Criteria\n\nA participant will be deemed eligible for enrollment only if all of the following criteria are met:\n\n1. Diagnosis of HIV infection, with a current history of highly active antiretroviral therapy (HAART) for a minimum duration of two years.\n2. Age between 18 and 65 years, inclusive.\n3. Plasma HIV RNA level \\\u003C 50 copies\u002FmL (virologic suppression).\n4. CD4⁺ T cell count \\> 200 cells\u002FμL.\n5. Adequate hematologic function defined as:\n\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Platelet count ≥ 75 × 10⁹\u002FL;\n   * Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL;\n   * White blood cell count ≥ 2 × 10⁹\u002FL.\n6. Adequate hepatic and renal function defined as:\n\n   * Serum creatinine ≤ 1.5 × upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN;\n   * Total bilirubin ≤ 2 × ULN;\n   * Prothrombin time (PT) prolongation \\\u003C 3 seconds.\n7. Hemodynamically stable with a left ventricular ejection fraction (LVEF) ≥ 45%.\n8. Negative serum or urine pregnancy test for females of childbearing potential.\n9. Willingness of the participant to:\n\n   * Practice effective contraception during the study period and for one year following completion of the trial;\n   * Voluntarily provide written informed consent and comply with scheduled follow up visits and study procedures.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from study participation:\n\n1. Presence of severe cardiovascular, respiratory, or hematologic disease; active infectious disease (other than controlled HIV infection); or active malignancy.\n2. Positive serology for hepatitis B surface antigen (HBsAg) or detectable hepatitis C virus RNA (HCV RNA).\n3. Diagnosis of chronic kidney disease (CKD).\n4. History or presence of acute or chronic pancreatitis.\n5. Active severe peptic ulcer disease.\n6. Current severe neurologic or psychiatric disorder.\n7. History of alcohol abuse or illicit substance use disorder.\n8. Known allergic diathesis or hypersensitivity to any component of the investigational agents.\n9. Female participants who are pregnant, lactating, or of childbearing potential and unwilling to adhere to required contraceptive measures.\n10. Concurrent use of immunosuppressive agents.\n11. Any other condition that, in the opinion of the investigator, renders the participant unsuitable for study participation.",{"count":291,"type":24},20,[115,90],"This study aims to investigate the safety and preliminary efficacy of an innovative therapeutic strategy combining chidamide with NKG2D-directed chimeric antigen receptor natural killer (CAR-NK) cells in individuals living with HIV. The approach is predicated on the \"shock and kill\" paradigm: chidamide is employed to reactivate latent HIV reservoirs and upregulate surface target ligands (NKG2D ligands) on infected cells; subsequently, allogeneic NKG2D CAR-NK cells are infused to specifically recognize and eliminate these \"marked\" cells.\n\nThis is a phase I, open-label, single-arm clinical trial comprising two distinct stages: a dose-escalation phase (phase Ia, utilizing a \"1+3+3\" design) and a dose-expansion phase (phase Ib). A total of 20 HIV-infected individuals who are stable on antiretroviral therapy (ART) and have suppressed plasma viremia are planned for enrollment. Participants will receive oral chidamide over approximately five weeks, followed by two cycles of intravenous CAR-NK cell infusion.\n\nThe primary endpoint is the safety and tolerability of the regimen, with particular attention to immune-related adverse events including cytokine release syndrome (CRS). Secondary endpoints encompass exploratory assessments of potential virologic and immunologic effects, such as alterations in plasma HIV RNA, cell-associated viral nucleic acids, and CD4+ T-cell counts. This study is intended to provide initial human safety data and preliminary evidence regarding the potential of this combination strategy to contribute toward a functional cure for HIV infection.",[139],[296,297,298],"HIV","CAR-NK","Functional cure","2026-05-04",{"date":301,"type":39},"2026-05-11",{"date":281,"type":24},{"date":304,"type":24},"2027-12-30",{"name":45,"class":46},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":133,"enrollmentInfo":313,"targetDuration":4,"studyType":25,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":331,"locationsCount":4},"100636194","pb-18-probiotic-for-mild-to-moderate-depression-100636194","NCT07562516","PB-18 Probiotic for Mild to Moderate Depression","A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Efficacy and Safety of Bifidobacterium PB-18 in Adults With Mild to Moderate Depressive Disorder and to Explore Its Gut-Brain Axis Mechanisms","Inclusion Criteria:\n\n* Outpatient or inpatient participants, aged 18 to 65 years (inclusive), of any sex\n* Current episode meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for depressive disorder\n* Baseline score on the 17-Item Hamilton Depression Rating Scale is 7 to 24, inclusive\n* No concomitant use of antidepressants or other psychotropic medications during the study\n* Elementary school education or above, able to understand the study requirements and complete the rating scales\n* Participant personally signs the informed consent form and is willing to complete follow-up according to the study protocol\n\nExclusion Criteria:\n\n* Current or past diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria, of bipolar disorder, schizophrenia spectrum and other psychotic disorders, neurocognitive disorders, neurodevelopmental disorders, or substance-related and addictive disorders\n* Presence of significant psychotic symptoms, such as delusions or hallucinations\n* Severe or unstable diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidneys, endocrine system, hematologic system, or other systems that, in the investigator's judgment, make the participant unsuitable for the study\n* Evident suicide risk, defined as a score of 1 or higher on the suicide item of the 17-Item Hamilton Depression Rating Scale\n* Active inflammatory disease\n* Gastrointestinal infection, tumor, or other organic digestive disease, including but not limited to irritable bowel syndrome, Crohn disease, ulcerative colitis, or celiac disease\n* History of major gastrointestinal surgery\n* Use of antibiotics, probiotics, prebiotics, or related functional products within 1 month before study entry\n* Allergy to the study product or any of its components\n* Pregnant or breastfeeding women\n* Unable or unwilling to take the study product as required by the protocol\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study",{"count":314,"type":24},88,[27],"The goal of this clinical trial is to learn if Bifidobacterium PB-18 can treat mild to moderate depressive disorder in adults aged 18 to 65 years who are not taking antidepressants or other psychotropic medications during the study. It will also learn about the safety of Bifidobacterium PB-18 and explore its potential effects on the gut-brain axis. The main questions it aims to answer are:\n\nDoes Bifidobacterium PB-18 increase the response rate at Week 8, defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17)?\n\nWhat adverse events occur in participants receiving Bifidobacterium PB-18?\n\nHow do gut microbiota, metabolite profiles, and related biological markers change after treatment with Bifidobacterium PB-18?\n\nResearchers will compare Bifidobacterium PB-18 with a placebo, a look-alike powder that does not contain PB-18, to see if Bifidobacterium PB-18 improves depressive symptoms.\n\nParticipants will:\n\nBe randomly assigned to receive Bifidobacterium PB-18 or placebo in a 1:1 ratio Take the assigned study product once daily for 8 weeks Visit the study site at baseline, Week 4, and Week 8 for symptom and safety assessments Complete study questionnaires, including HAMD-17, HAMA, PSQI, and CBCT Provide blood and stool samples at baseline and Week 8 for exploratory biological analyses",[318],"Depressive Disorder",[320,321,322,275,323,324,325],"Bifidobacterium PB-18","Probiotic","Depression","Placebo-Controlled","Randomized","Double-Blind",{"date":327,"type":39},"2026-05-07",{"date":329,"type":24},"2026-05-05",{"date":125,"type":24},{"name":45,"class":46},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":25,"phases":341,"briefSummary":343,"conditions":344,"keywords":348,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100635601","phase-3-a-randomized-double-blind-placebo-controlled-prospective-multi-center-trial-evaluating-the-improvement-of-nutritional-status-and-sarcopenia-with-silkworm-pupa-tablets-in-patients-with-malignancies-100635601","NCT07554807","A Randomized, Double-blind, Placebo-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Sarcopenia With Silkworm Pupa Tablets in Patients With Malignancies","Inclusion Criteria:\n\n1. fully understand and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures\n2. Any gender, age at ICF signing: ≥ 18 years, ≤ 80 years\n3. Confirmed diagnosis of malignancy\n4. At screening\u002F enrollment, meet the definition of sarcopenia according to the 2019 Asian Working Group for Sarcopenia\n5. Generally good condition, ECOG performance status ≤ 2\n6. Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study\n\nExclusion Criteria:\n\n1. Presence of gastrointestinal obstruction preventing oral intake at screening\u002Fenrollment\n2. Use of immunosuppressants at screening\u002Fenrollment\n3. Life expectancy ≤ 3 months\n4. Presence of malabsorption syndrome or any condition affecting gastrointestinal absorption, e.g., chronic diarrhea (watery stools; daily stool frequency ≥ 5 times)\n5. Patients planning pregnancy, pregnant, or breastfeeding\n6. Known allergy to any component of the investigational products\n7. Presence of severe primary diseases of the heart, brain, lung, liver, kidney, endocrine, blood, nervous systems or other acute\u002Fchronic diseases that could significantly affect treatment and prognosis\n8. Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or patients deemed unsuitable for the study by the investigator","80 Years",{"count":340,"type":24},480,[342],"PHASE3","This is a randomized, double-blind, placebo-controlled, parallel-group, prospective, multi-center clinical trial, to evaluate the efficacy of silkworm pupa tablets in improving nutritional status and sarcopenia in patients with malignancies who have completed comprehensive treatment. All participants will be randomly assigned (1:1) to either experimental group (n=240): dietary advice + Wanshili Longbao Silkworm Pupa Tablets (main ingredients: freeze-dried active mulberry cocoon pupa powder, maltitol, milk mineral salt, mannitol, maltodextrin), 2 tablets three times daily before meals for 3 months, or control group (n=240): dietary advice + placebo (identical appearance), 2 tablets three times daily before meals for 3 months. The primary endpoint is sarcopenia prevalence at 3 months (based on AWGS 2019 criteria: muscle strength, muscle mass, and physical function).",[345,346,347],"Nutritional Deficiency","Gastrointestinal Cancers","Sarcopenia",[349,350,351],"silkworm pupa tablets","gastrointestinal malignancies","nutritional risk","2026-04-21",{"date":354,"type":39},"2026-04-28",{"date":356,"type":24},"2026-04-01",{"date":358,"type":24},"2028-03-31",{"name":45,"class":46},4,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":368,"enrollmentInfo":369,"targetDuration":371,"studyType":158,"phases":4,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":104},"100633367","ai-assisted-decision-making-of-reoperation-for-postoperative-bleeding-of-gastric-cancer-100633367","NCT07525765","AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer","A Multicenter Observational Study to Develop and Validate a Deep Learning Model for Dynamic Assessment of Postoperative Bleeding Risk to Assist Re-operation Decision-Making in Patients With Gastric Cancer","Inclusion Criteria:\n\n1. Age: Patients aged ≥ 18 years.\n2. Diagnosis: Histologically confirmed primary gastric cancer.\n3. Surgical Procedure: Underwent radical gastrectomy (including proximal, distal, or total gastrectomy).\n4. Consent: Provision of written informed consent (required specifically for the prospective phase).\n5. Data Completeness: Availability of complete preoperative clinical data and postoperative follow-up records covering at least the first 15 days post-surgery.\n6. Oncological History: No history of other primary malignant tumors.\n\nExclusion Criteria:\n\n1. Surgical Type: Patients who underwent non-radical resection or emergency surgery.\n2. Data Quality: Missing rate of key data fields exceeds 20%.\n3. Preoperative Condition: Presence of severe preoperative infection or organ failure.\n4. Follow-up Compliance: Unwillingness to participate in prospective follow-up or inability to complete the follow-up schedule (applicable only to the prospective phase).","90 Years",{"count":370,"type":24},7000,"30 Days","The goal of this observational study is to develop and validate a deep learning model to dynamically assess postoperative bleeding risk and assist in decision-making for re-operation in adult patients (≥18 years) diagnosed with primary gastric cancer undergoing radical gastrectomy. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nCan an AI model based on perioperative dynamic physiological parameters and precise intraoperative blood loss accurately predict the risk of postoperative bleeding requiring re-operation? Does the application of this AI model improve clinical decision-making (e.g., earlier warning time, optimal intervention timing) and patient outcomes (e.g., mortality, length of stay)? Since there is no comparison group (this is a pure observational study without intervention arms), researchers will not compare different treatment groups. Instead, the investigators will evaluate the model's performance (sensitivity, negative predictive value, AUC, calibration) using retrospective data for training and prospective multi-center data for external validation.\n\nParticipants will:\n\nUndergo standard radical gastrectomy and routine postoperative care as per clinical practice (no study-specific interventions).\n\nHave their perioperative data collected, including demographics, medical history, vital signs, laboratory tests (blood gas analysis), surgical details, and precise intraoperative blood loss measurements.\n\n(For prospective participants only) Provide informed consent and complete follow-up assessments up to 30 days post-surgery.",[374,375],"Gastrectomy for Gastric Cancer","Gastric Cancer","2026-04-07",{"date":378,"type":39},"2026-04-13",{"date":380,"type":24},"2026-04-10",{"date":382,"type":24},"2028-01-31",{"name":45,"class":46},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":19,"minAge":391,"maxAge":338,"enrollmentInfo":392,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":404,"leadSponsor":406,"locationsCount":104},"100632221","18f-fapi-petct-and-mri-in-gastric-cancer-100632221","NCT07510867","18F-FAPI PET\u002FCT and MRI in Gastric Cancer","A Prospective Clinical Study on the Application of 18F-FAPI PET Imaging Combined With Multi-parameter MRI in the Diagnosis of Gastric Cancer","Inclusion Criteria:\n\n1. Patients suspected or diagnosed with gastric cancer\n2. 18F-FAPI PET\u002FCT has been performed\n3. Gastric MRI with both non-contrast and contrast-enhanced scans performed\n\nExclusion Criteria:\n\n1. Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;\n2. Severe uncontrollable diseases or active infections;\n3. Ineligible participants who cannot provide informed consent for the study;\n4. Patients with suboptimal image quality in 18F-FAPI PET\u002FCT\n5. Patients with suboptimal MRI image quality enhancement","20 Years",{"count":393,"type":24},230,"The purpose of this study was to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET\u002FCT combined with multiparameter MRI in gastric cancer.",[375],[397,398,399],"FAPI","PET","MRI","2026-03-31",{"date":402,"type":39},"2026-04-06",{"date":281,"type":24},{"date":405,"type":24},"2028-05-31",{"name":45,"class":46},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":154,"enrollmentInfo":414,"targetDuration":4,"studyType":25,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":104},"100581422","phase-2-scrt-capeox-serplulimab-for-msspmmr-rectal-cancer-with-oligometastases-100581422","NCT06850103","SCRT-CAPEOX-Serplulimab for MSS\u002FpMMR Rectal Cancer With Oligometastases","A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases","Inclusion Criteria:\n\n\\- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures.\n\nAge between 18-75 years.\n\nHistologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge.\n\nSynchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.), with ≤2 metastatic sites and ≤5 total metastatic lesions.\n\nMicrosatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or proficient mismatch repair (pMMR) status confirmed by immunohistochemistry showing positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2).\n\nAt least one measurable lesion according to RECIST v1.1 criteria.\n\nEastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n\nAdequate organ function and bone marrow reserve, defined as follows:\n\nComplete blood count:\n\nAbsolute Neutrophil Count (ANC) ≥1.5×109\u002FL Platelet count (PLT) ≥100×109\u002FL Hemoglobin (HGB) ≥10.0g\u002FdL\n\nLiver function:\n\nTotal Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN) Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN Serum albumin (ALB) ≥35 g\u002FL\n\nRenal function:\n\nSerum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (calculated using Cockcroft-Gault formula \\[see Appendix 3\\] or standard 24-hour urine collection method) Urine protein by dipstick \\\u003C2+ For subjects with baseline urine protein ≥2+ by dipstick, 24-hour urine protein must be \\\u003C1g\n\nCoagulation:\n\nInternational Normalized Ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Certain anticoagulant medications (such as antiplatelet agents, vitamin K antagonists) must be discontinued 7-14 days before surgery and replaced with alternative medications (such as low molecular weight heparin) No concurrent serious diseases that would threaten subject survival (leading to expected survival \\\u003C5 years).\n\nWomen of childbearing potential and men whose partners are of childbearing potential must use effective contraception during the entire treatment period and for 6 months after treatment completion. Female subjects must either have evidence of post-menopausal status, or if pre-menopausal, have a negative urine or serum pregnancy test.\n\nExclusion Criteria:\n\n\\- More than 2 metastatic sites or more than 5 total metastatic lesions confirmed by imaging evaluation.\n\nPrior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n\nPrevious treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.\n\nConcurrent participation in another clinical trial, except for observational (non-interventional) studies or survival follow-up phase of interventional studies.\n\nReceipt of any investigational drug within 4 weeks prior to first dose of study drug.\n\nHistory of blood transfusion or use of G-CSF, GM-CSF, EPO, TPO, or IL-11 within 14 days prior to screening laboratory tests.\n\nUse of immunosuppressive medications within 4 weeks prior to first dose of study drug, excluding:\n\nIntranasal inhaled corticosteroids or local steroid injections Systemic corticosteroids at ≤10 mg\u002Fday prednisone equivalent Corticosteroids as premedication for allergic reactions (e.g., CT contrast) Traditional Chinese medicines with anti-tumor indications or immunomodulatory effects within 1 week prior to first dose Receipt of live or attenuated vaccines within 4 weeks prior to first dose or anticipated during the study period.\n\nMajor surgery within 4 weeks prior to first dose (e.g., craniotomy, thoracotomy, or laparotomy), anticipated major surgery during treatment (excluding protocol-specified rectal cancer surgery), or presence of unhealed wounds, ulcers, or fractures.\n\nKnown active or suspected autoimmune disease or history within past 2 years (exceptions: eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in past 2 years; hypothyroidism requiring only hormone replacement; Type I diabetes requiring only insulin).\n\nKnown history of primary immunodeficiency.\n\nActive tuberculosis, current anti-TB treatment, or anti-TB treatment within 1 year prior to first dose.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown allergy to capecitabine, oxaliplatin, serplulimab, or other monoclonal antibody components.\n\nClinically significant ascites, pleural effusion requiring intervention, or symptomatic pericardial effusion requiring drainage.\n\nHIV infection (HIV antibody positive).\n\nAcute or chronic active hepatitis B (defined as HBsAg positive or HBcAb positive only with HBV DNA ≥2000 IU\u002FmL or ≥1×104 copies\u002FmL) or hepatitis C (defined as HCV antibody positive with detectable HCV RNA).\n\nActive syphilis infection requiring treatment.\n\nSevere infection within 4 weeks prior to first dose, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; therapeutic oral or IV antibiotics within two weeks prior to first dose.\n\nSymptomatic congestive heart failure (NYHA class II-IV) or LVEF \\\u003C50%; symptomatic or uncontrolled arrhythmias; congenital long QT syndrome or QTc \\>500 ms at screening (Fridericia's formula).\n\nUncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite standard therapy, history of hypertensive crisis or encephalopathy.\n\nSevere bleeding diathesis or coagulation disorders, or current thrombolytic therapy.\n\nAny arterial thromboembolic events within 6 months prior to first dose, including myocardial infarction, unstable angina, stroke, or TIA.\n\nEsophageal or gastric varices requiring immediate intervention; high bleeding risk subjects require endoscopic evaluation within 3 months before enrollment.\n\nHistory of GI perforation and\u002For fistula within 6 months prior to first dose.\n\nLife-threatening bleeding event within 3 months prior to first dose, or Grade 3\u002F4 GI\u002Fvariceal bleeding requiring transfusion, endoscopy, or surgery.\n\nHistory of DVT, PE, or other serious thromboembolism within 3 months prior to first dose (excluding catheter-related thrombosis or superficial thrombosis).\n\nUncontrolled metabolic disorders or other non-malignant conditions causing high medical risk or uncertain survival evaluation.\n\nHepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B \\>7 or worse cirrhosis.\n\nBowel obstruction (including incomplete requiring parenteral nutrition); conditions with perforation risk; history of extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\nInterstitial lung disease requiring treatment; history of pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, organizing pneumonia, or severe pulmonary dysfunction.\n\nSignificant malnutrition (5% weight loss within 1 month or 15% within 3 months of consent, or \\>50% reduced intake for 1 week), unless corrected for ≥4 weeks before first dose.\n\nHistory of other primary malignancies, except:\n\nCured malignancies with ≥2 years disease-free and low recurrence risk Well-treated non-melanoma skin cancer or lentigo maligna Well-treated carcinoma in situ\n\nOther acute or chronic conditions that could:\n\nIncrease study participation risks Interfere with result interpretation Make subject unsuitable per investigator judgment Neurological, psychiatric, or social conditions affecting compliance or safety assessment.\n\nAlcohol, drug, or substance abuse affecting drug administration or toxicity analysis.\n\nPregnant or breastfeeding women.\n\nConditions interfering with medication management or toxicity analysis due to alcohol, drug, or substance use.\n\nPregnancy or breastfeeding.",{"count":415,"type":24},51,[90],"Background and Significance:\n\nColorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.\n\nCurrent Treatment Landscape:\n\nThe management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).\n\nTreatment Evolution and Challenges:\n\nWhile the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.\n\nInnovative Approach:\n\nRecent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable\u002Fproficient mismatch repair (MSS\u002FpMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.\n\nResearch Objective:\n\nThis project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS\u002FpMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.\n\nResearch Innovation:\n\nThe study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS\u002FpMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.",[419,420,421,422,423],"Colorectal Carcinoma","Oligometastases","pMMR","MSS","iTNT","2026-03-22",{"date":426,"type":39},"2026-03-25",{"date":428,"type":39},"2025-04-22",{"date":430,"type":24},"2032-12",{"name":45,"class":46},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":19,"minAge":224,"maxAge":154,"enrollmentInfo":438,"targetDuration":4,"studyType":25,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":453,"leadSponsor":455,"locationsCount":135},"100623426","phase-3-fludarabine-plus-melphalan-versus-addition-of-venetoclax-to-fludarabinemelphalan-conditioning-regimen-for-allogeneic-hematopoietic-stem-cell-transplantation-in-amlmds-patients-aged--50-years-a-multicenter-randomized-phase-3-trial-100623426","NCT07396480","Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine\u002FMelphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML\u002FMDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial","Inclusion Criteria:\n\n1. Aged \\> 50 years;\n2. Confirmed as acute myeloid leukemia (AML) in remission prior to transplantation, myelodysplastic syndrome (MDS; IPSS: Intermediate-2, high; or IPSS-R: Intermediate, high, very high; or IPSS-M: moderate-high, high, and very high), or myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) by morphology, immunology, cytogenetics and molecular biology (MICM) typing;\n3. Having an eligible donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (Allo-HCT) from a related or unrelated donor;\n4. Karnofsky Performance Score ≥ 70;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status \\\u003C 3;\n6. Expected survival time \\> 12 weeks;\n7. Voluntarily signing the informed consent form and being able to understand and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Complicated with severe cardiac insufficiency with a left ventricular ejection fraction (EF) \\\u003C 60%; or complicated with severe arrhythmia, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n2. Complicated with severe pulmonary insufficiency (obstructive and\u002For restrictive ventilatory disorder), and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n3. Complicated with severe liver function impairment, with liver function indicators (alanine aminotransferase \\[ALT\\], total bilirubin \\[TBIL\\]) exceeding 3 times the upper limit of normal (ULN); and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n4. Complicated with severe renal insufficiency, with serum creatinine (Cr) exceeding 2 times the upper limit of normal (ULN); or with a 24-hour creatinine clearance rate (Ccr) \\\u003C 50 ml\u002Fmin, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n5. Suffering from severe active infection prior to transplantation, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n6. Having a history of allergic reactions or severe adverse reactions to the drugs involved in the conditioning regimen, and assessed by the investigator as ineligible for enrollment;\n7. Other reasons for ineligibility assessed by the investigator.",{"count":439,"type":24},186,[342],"Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) serves as a curative treatment modality for the vast majority of patients with hematological malignancies. Historically, due to the relatively high treatment-related mortality rate associated with Allo-HCT, this therapy was primarily administered to younger patients. However, the median age at onset of most hematological malignancies falls within the elderly population. For instance, the median ages at onset of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) are 68 and 77 years, respectively. In recent years, with the advancement of transplantation techniques and the application of Reduced-intensity Conditioning (RIC) regimens, a growing number of elderly patients have undergone Allo-HCT. Data from the Center for International Blood and Marrow Transplant Research (CIBMTR) indicate that in 2017, 31% of patients who received Allo-HCT were aged over 60 years, and 6% were over 70 years old. Over the past decade, the number of elderly patients undergoing Allo-HCT has increased significantly.\n\nGiven that most elderly patients cannot tolerate conventional myeloablative conditioning regimens, RIC regimens based on Fludarabine (Flu) combined with Busulfan (Bu), or Fludarabine (Flu) combined with Melphalan (Mel) are currently widely used in elderly patients undergoing Allo-HCT. Nevertheless, the post-transplant relapse rate remains as high as 30%-55%, and the long-term GVHD-free and Relapse-free Survival (GRFS) rate fluctuates between 21% and 59%, suggesting that the efficacy of transplantation needs to be further improved. Further comparison of the commonly used RIC regimens in elderly patients-namely Flu+Bu (2-day), Flu+Bu (4-day) and Flu+Mel-has demonstrated that the Flu+Mel regimen yields superior transplantation outcomes over the Flu+Bu regimens.\n\nAt present, the optimal RIC regimen for elderly patients with hematological malignancies has not yet been clearly defined. The selection of transplantation conditioning regimens for elderly patients should strike a balance between reducing non-relapse mortality and decreasing post-transplant relapse. Over the past 20 years, an increasing number of targeted drugs acting on specific cellular signaling pathways, anti-apoptotic proteins, epigenetic regulators, and monoclonal antibodies have been introduced into clinical practice, thereby revolutionizing the treatment landscape of hematological malignancies. These novel targeted therapies not only bring hope of achieving remission to patients with hematological tumors resistant to traditional chemotherapy, but also the combined application of novel drugs and Allo-HCT is bound to fundamentally transform the overall technical system of hematopoietic stem cell transplantation. Venetoclax is a potent and selective oral inhibitor targeting the BH3 domain of the anti-apoptotic protein Bcl-2. In 2018, the FDA approved Venetoclax as a first-line induction chemotherapy agent for elderly AML patient's ineligible for intensive chemotherapy, with a complete remission rate of up to 67% and favorable tolerability¹¹. Preclinical studies using Allo-HCT animal models have confirmed that the addition of a Bcl-2 inhibitor to RIC regimens can promote donor cell engraftment, reduce the incidence of GVHD, without impairing the graft-versus-leukemia (GVL) effect¹². In recent years, clinical trials have reported the efficacy and safety of the conditioning regimen combining Venetoclax with Flu+Bu in patients with myeloid malignancies undergoing Allo-HCT. Our research center has demonstrated the favorable safety profile and promising long-term survival outcomes of the Venetoclax plus Flu+Mel conditioning regimen in a phase II clinical trial involving patients aged over 50 years with AML\u002FMDS undergoing Allo-HCT (2024 EBMT Poster B093; 2025 EBMT Poster B126). However, the long-term superiority of this novel regimen over the conventional Flu+Mel conditioning regimen remains to be clarified.\n\nTherefore, based on the existing findings from clinical studies and Allo-HCT animal model research, we hypothesize that incorporating Venetoclax into the Fludarabine+Melphalan conditioning regimen for elderly patients undergoing Allo-HCT is expected to improve long-term post-transplant survival and further enhance the transplantation efficacy in this patient population.",[443,444,445,446,447,448],"Venentoclax","Myeloid Malignancies","Conditioning","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Acute Myeloid Leucemia","Myeldysplastic Syndrome (MDS)","2026-03-16",{"date":451,"type":39},"2026-03-17",{"date":41,"type":24},{"date":454,"type":24},"2030-06-30",{"name":45,"class":46},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":18,"sex":19,"minAge":391,"maxAge":86,"enrollmentInfo":463,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":4},"100628939","characteristic-electroencephalogram-of-general-anesthesia-100628939","NCT07468162","Characteristic Electroencephalogram of General Anesthesia","Analysis of the Characteristic Electroencephalogram of Patients Undergoing Orthopedic Surgery During the Induction of General Anesthesia and the Unconscious State and Recovery Period With Electroencephalogram Monitoring Device","Inclusion Criteria:\n\n* Age: 20 - 60 years old. BMI: 18 ≤ BMI ≤ 24 kg\u002Fm2. Right-handed. ASA classification: I - II. Patients scheduled for extremity surgery of upper and lower limbs and undergoing nerve block, those who understand and sign the informed consent form, and those receiving non-endotracheal general anesthesia with remimazolam or dexmedetomidine or midazolam, with Mallampati classification: I - II.\n\nExclusion Criteria:\n\n* Skin infection at the site of nerve block puncture; history of smoking and alcohol abuse, history of brain surgery, history of cerebral infarction, mental and neurological disorders (MMSE \\\u003C 18, 3D-CAM positive), history of taking any psychotropic or opioid drugs within 2 weeks, hearing impairment, cardiovascular disease, expected difficulty in airway management or sleep apnea syndrome, drug (including those with a history of allergic reaction to the test drug or contraindications for use) or food allergies, pregnant or lactating patients, patients or family members who refuse to participate, and those who refuse to undergo nerve block.",{"count":464,"type":24},48,"Patients were enrolled according to predefined inclusion and exclusion criteria. Following surgical admission, standard monitoring was initiated, including continuous assessment of heart rate, blood pressure, electrocardiogram (ECG), and peripheral capillary oxygen saturation (SpO₂). A peripheral intravenous line was established. Bispectral index (BIS) monitoring was performed continuously using a BIS monitor to assess frontal lobe electroencephalographic activity. Based on the type of surgical procedure, regional nerve block was administered. Upon confirmation of adequate block efficacy, patients were assigned to treatment groups according to sealed envelope randomization, and corresponding intravenous sedative regimens were initiated. Sedative induction agents were administered as follows: Group A received remimazolam at 0.08 mg\u002Fkg; Group B received dexmedetomidine at 1 μg\u002Fkg over 10 minutes; Group C received midazolam at 0.05 mg\u002Fkg. Maintenance infusions were as follows: Group A received remimazolam at 1 mg\u002Fkg·h; Group B received dexmedetomidine at 0.2-0.7 μg\u002Fkg·h; for Group C, if consciousness was not sufficiently suppressed with the initial dose, midazolam was supplemented in increments of 0.01 mg\u002Fkg, not exceeding a total dose of 0.1 mg\u002Fkg. Following induction, sedation depth was assessed every 2 minutes using the Observer's Assessment of Alertness\u002FSedation (OAA\u002FS) scale, with auditory stimulation applied every 30 seconds until the patient no longer responded. The time to loss of response to auditory stimuli and the time to loss of consciousness were recorded. Surgical intervention was then performed. Ten minutes prior to anticipated completion of surgery, sedative infusion was discontinued. Sedation depth was reassessed every 2 minutes using the OAA\u002FS scale, with repeated auditory stimulation every 30 seconds to determine the time to return of response and time to recovery of consciousness. If the patient had not achieved an OAA\u002FS score of 5 within 30 minutes after discontinuation of sedation, flumazenil was administered as a reversal agent. Once the OAA\u002FS score reached 5 or spontaneous responses to auditory stimuli were observed-indicating transition back to a responsive state-and complete electroencephalographic data had been collected, no further intervention was required.",[467,468],"EEG Data Analysis","Orthopedic Surgery","2026-03-09",{"date":471,"type":39},"2026-03-12",{"date":473,"type":24},"2026-03-20",{"date":475,"type":24},"2028-01-12",{"name":45,"class":46},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":25,"phases":487,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":104},"100626967","phase-3-comparison-of-etamsylate-versus-placebo-to-prevent-bleeding-in-hsct-100626967","NCT07442513","Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT","Comparison of Etamsylate Versus Placebo to Prevent Bleeding in Hematopoietic Stem Cell Transplantation Recipients：a Randomized, Double-blind, Phase 3, Clinical Study","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive), regardless of gender;\n2. Patients diagnosed with a hematological disease requiring hematopoietic stem cell transplantation;\n3. Expected platelet count ≤ 10 x 10⁹\u002FL persisting for 5 days or more;\n4. Normal coagulation function;\n5. Adequate organ function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times the Upper Limit of Normal (ULN), Total Bilirubin ≤ 2 x ULN; Serum Creatinine ≤ 2 x ULN; Creatinine Clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Echocardiography (ECHO);\n6. Voluntary provision of signed informed consent, with the ability to understand and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia confirmed according to WHO diagnostic criteria;\n2. Pregnant or breastfeeding women, and women of childbearing potential unwilling to use effective contraception;\n3. Presence of active bleeding or infection;\n4. History of diagnosed primary immune thrombocytopenia or hemolytic uremic syndrome;\n5. Patients with known hereditary or acquired hemorrhagic disorders;\n6. Patients receiving anticoagulant or antiplatelet therapy;\n7. Patients with severe cardiac insufficiency (left ventricular ejection fraction \\[EF\\] \\\u003C 60%); or severe arrhythmias: history of clinically significant QTc prolongation (male \\> 450 ms; female \\> 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block; myocardial infarction within 1 year prior to enrollment; or symptomatic coronary artery disease requiring medication; patients with severe liver impairment (liver function indices \\[ALT, TBIL\\] \\> 3 times the upper limit of normal \\[ULN\\]);\n8. Patients with severe pulmonary insufficiency (obstructive and\u002For restrictive ventilatory defects);\n9. Patients with severe renal insufficiency (renal function index \\[Cr\\] \\> 2 times ULN); or 24-hour urinary creatinine clearance rate (Ccr) \\\u003C 50 ml\u002Fmin;\n10. Patients with mental disorders or other conditions preventing provision of informed consent and compliance with study treatment and procedural requirements;\n11. Other reasons deemed by the investigator to make the patient ineligible for inclusion.","70 Years",{"count":486,"type":24},404,[342],"This study employs a prospective, randomized, double-blind, placebo-controlled design. It aims to compare the efficacy of etamsylate versus placebo in preventing bleeding complications in patients with thrombocytopenia following hematopoietic stem cell transplantation.",[490,491],"Hematopoietic Stem Cell Transplantation","Thrombocytopenia",[493,494,495,496],"etamsylate","Hematopoietic Stem Cell Transplantation recipients","thrombocytopenia","bleeding events","2026-02-25",{"date":499,"type":39},"2026-03-02",{"date":501,"type":39},"2025-12-16",{"date":503,"type":24},"2027-10-31",{"name":45,"class":46},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":25,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":104},"100554888","phase-2-optimize-study---orelabrutinib-combined-with-brg-in-untreated-marginal-zone-lymphoma-mzl-100554888","NCT06504940","Optimize Study - Orelabrutinib Combined With BR\u002FG in Untreated Marginal Zone Lymphoma (MZL)","Orelabrutinib Combined With BR\u002FG Followed by Orelabrutinib Maintenance Therapy for Newly Diagnosed Marginal Zone Lymphoma (MZL): A Prospective ,Multicenter, Clinical Study","Inclusion Criteria:\n\n1. For Cohort A: Age 18-70 years, physical condition assessed by a physician as suitable for chemotherapy; for Cohort B: Age 70 or older or under 70 years of age assessed by a physician as unsuitable for chemotherapy.\n2. Gender is not limited.\n3. Confirmed by histopathology, marginal zone lymphoma including MALT, SMZL, NMZL.\n4. Progression, recurrence after local treatment, or unsuitable for local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment).\n5. ECOG performance score 0-3 points (if the score is 3 points, the physician needs to assess that the deterioration of physical condition is mainly due to tumor burden).\n6. Indications for treatment (with B symptoms, blood cell decline, bleeding, large mass, rapid progression of tumors, etc.).\n7. Major organ functions meet the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥75g\u002FL; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10\\^9\u002FL, platelets ≥50×10\\^9\u002FL, hemoglobin ≥50g\u002FL. b) Blood biochemistry: Total bilirubin ≤1.5 times the upper limit of normal (ULN), AST or ALT ≤2 times ULN; serum creatinine ≤1.5 times ULN; serum amylase ≤ULN. c) Coagulation function: International normalized ratio (INR) ≤1.5 times ULN.\n8. Life expectancy ≥3 months.\n9. Voluntarily sign a written informed consent form before the trial screening.\n\nExclusion Criteria:\n\n1. Currently or previously have other malignant tumors, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years.\n2. Lymphoma involving the central nervous system or transformation to a higher grade.\n3. Have uncontrollable or significant cardiovascular diseases, including: a) Within 6 months before the first administration of the study drug, there is a history of New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction, or arrhythmias requiring treatment at the time of screening, with a left ventricular ejection fraction (LVEF) \\<50%. b) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy). c) A history of clinically significant QTc interval prolongation, or a QTc interval \\>470ms in females and \\>450ms in males during the screening period. d) Symptomatic or medication-requiring coronary artery heart disease subjects. e) Subjects with uncontrollable hypertension (despite lifestyle improvements and the use of reasonable, tolerable, and adequate doses of three or more antihypertensive drugs, including diuretics, for more than 1 month, blood pressure is still not at the standard, or it is only effectively controlled when taking four or more antihypertensive drugs).\n4. Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or the investigator believes there is a clear bleeding tendency.\n5. History of deep vein thrombosis or pulmonary embolism within the past six months.\n6. Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction), or subjects who have undergone total gastrectomy.\n7. History of organ transplantation or allogeneic bone marrow transplantation.\n8. Major surgery within 6 weeks before screening or minor surgery within 2 weeks before screening. Major surgery is surgery that uses general anesthesia, but endoscopic examinations for diagnostic purposes are not considered major surgery. Insertion of vascular access devices will be exempt from this exclusion criterion.\n9. Active infection or uncontrolled HBV (positive for HBsAg and\u002For HBcAb with positive HBV DNA titer), positive for HCV Ab, HIV\u002FAIDS, or other serious infectious diseases; define active infection.\n10. Subjects currently with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, etc., that seriously affect lung function.\n11. Previously treated with BTK, BCR pathway inhibitors (such as PI3K, Syk), and BCL-2 inhibitors.\n12. Pregnant, breastfeeding women, and subjects of childbearing age who are unwilling to take contraceptive measures.\n13. Need to continuously take drugs with moderate to severe inhibitory effects on cytochrome P450 CYP3A or strong inductive effects.\n14. Other situations deemed unsuitable for participating in this trial by the investigator.",{"count":513,"type":24},69,[90],"This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.",[517],"Marginal Zone Lymphoma",[519,520,517],"orebrutinib","BTKi","2026-02-24",{"date":523,"type":39},"2026-02-27",{"date":525,"type":39},"2024-06-28",{"date":527,"type":24},"2029-07-08",{"name":45,"class":46},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":25,"phases":538,"briefSummary":539,"conditions":540,"keywords":546,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":556,"locationsCount":557},"100623358","phase-4-remimazolam-for-bronchoscopy-in-high-risk-patients-100623358","NCT07395596","Remimazolam for Bronchoscopy in High-Risk Patients","A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy","Inclusion Criteria:\n\n* ASA Class Ⅲ - Ⅳ\n* Scheduled for elective painless bronchoscopy -\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Patients who are uncooperative（e.g. due to mental illness）\n* Patients who are on chronic use of opioids, benzodiazepine - class hypnotics, or antidepressants\n* Patients with a history of allergy to the anesthetics used\n* Patients who are anticipated to have a difficult airway\n* Body mass index（BMI）\\\u003C18.5kg\u002Fm² or \\>30kg\u002Fm²\n* Preoperative oxygen saturation \\\u003C92% while breathing room air\n* Other：Patients who are deemed by the investigator to be unsuitable for participation in this trial",{"count":537,"type":24},360,[58],"Bronchoscopy is currently widely used for the diagnosis and treatment of various respiratory diseases. However, the operation of bronchoscopy is irritating, causes a strong stress response, and shares the airway with the patient, making the patient highly susceptible to respiratory and cardiovascular risks. Among these risks, hypoxia is the most common adverse event.Different drug regimens can be selected for anesthesia under deep sedation. The combination of analgesic agents can help reduce coughing during bronchoscopy. Therefore, we employ a combination of sedative and analgesic drugs for painless bronchoscopy procedures. Among sedatives, propofol is the most commonly used. However, due to its disadvantages, such as respiratory and circulatory depression, we have introduced a novel approach combining remimazolam for sedation. The aim is to investigate whether this new regimen, compared to traditional propofol-based sedation, can reduce the incidence of hypoxia, minimize circulatory depression, and lead to faster postoperative awakening and recovery. Additionally, we hope to observe fewer adverse events, such as perioperative nausea and vomiting, excessive secretions, dizziness, and chills.",[541,542,543,544,545],"Pulmonary Infection","Pulmonary Nodule","Phthisis","Endotracheal Tumour","Lymphadenectasis",[547,548,549,550],"hypoxia","remimazolam","propofol","fiberoptic bronchoscopy","2026-02-21",{"date":521,"type":39},{"date":554,"type":39},"2026-02-09",{"date":216,"type":24},{"name":45,"class":46},2,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":205,"enrollmentInfo":565,"targetDuration":4,"studyType":25,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":576,"leadSponsor":577,"locationsCount":104},"100624785","tms-for-improving-cognitive-function-in-bipolar-disorder-100624785","NCT07414147","TMS for Improving Cognitive Function in Bipolar Disorder","Targeting the Primary Visual Cortex-Hippocampus Circuit With Transcranial Magnetic Stimulation to Improve Cognition in Bipolar Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\n1: Age between 18 and 45 years; 2: Right-handed; 3: Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar disorder and are currently in a stable remission phase; 4: Hamilton Depression Rating Scale 24-item (HAMD-24) score \\\u003C 8; 5: Young Mania Rating Scale (YMRS) score \\\u003C= 7; 6: The participant and his\u002Fher legal guardian are willing to comply with the treatment procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1: Diagnosis of another primary psychiatric disorder judged by the investigators to be the predominant condition, with functional impairment exceeding that attributable to bipolar disorder; 2: Comorbid psychiatric disorders, including obsessive-compulsive disorder, personality disorders, anxiety spectrum disorders, intellectual disability, or substance use (dependence\u002Fabuse); 3: Inability to complete self-report symptom rating scales or the CANTAB cognitive assessment; 4: Prominent suicidal ideation (item 3 of the HAMD-24 \\>= 2); 5: History of severe physical illness or other medical conditions that may affect the central nervous system; 6: Neurological disorders or risk factors for seizures, such as a history of intracranial disease, head injury, abnormal electroencephalogram (EEG) findings, magnetic resonance imaging (MRI) evidence of structural brain abnormalities, or a family history of epilepsy; 8: Contraindications to MRI or transcranial magnetic stimulation, such as the presence of metallic or electronic implants (e.g., intracranial metallic foreign bodies, cochlear implants, cardiac pacemakers, vascular stents); 9: Receipt of electroconvulsive therapy (ECT) within 6 months prior to study enrollment; 10: Currently undergoing transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulatory interventions; 11: Pregnant or breastfeeding women, and women of childbearing potential with a positive urine pregnancy test.",{"count":314,"type":24},[27],"Bipolar disorder is a highly disabling psychiatric illness, and cognitive impairment is common in patients with bipolar depression as well as during remission, contributing substantially to functional disability and poorer prognosis. Currently, effective interventions specifically targeting cognitive deficits remain limited, highlighting the need for novel treatment strategies. Transcranial magnetic stimulation, a noninvasive neuromodulation technique, has shown potential benefits for depressive symptoms and cognitive functioning. Based on structural and functional neuroimaging evidence, this study proposes an individualized intermittent theta burst stimulation (iTBS) protocol targeting the primary visual cortex (V1) and its functional pathway to the hippocampus, combined with online cognitive training. This randomized, double-blind, parallel-group, sham-controlled trial will enroll 88 patients with bipolar disorder in remission phase and allocate them to active or sham stimulation. The intervention will be delivered over 5 days, with follow-up assessments through 6 weeks. The primary outcome is change in cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB). Secondary outcomes include changes in clinical symptom ratings, magnetic resonance imaging (MRI) biomarkers, and the incidence of adverse events. This study aims to evaluate the efficacy and safety of this targeted intervention and to provide evidence for precision treatment approaches to cognitive impairment in bipolar disorder.",[249,569],"Cognitive Impairment",[571],"intermittent theta burst stimulation","2026-02-10",{"date":574,"type":39},"2026-02-17",{"date":41,"type":24},{"date":125,"type":24},{"name":45,"class":46},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":25,"phases":588,"briefSummary":589,"conditions":590,"keywords":595,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":104},"100612909","phase-2-gilteritinib-plus-va-followed-by-consolidation-chemotherapy-in-newly-diagnosed-flt3-itd-aml-100612909","NCT07259707","Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML","A Single-Center, Prospective, Single-Arm Phase II Clinical Study of Consolidation With High-Dose Cytarabine Following Deep Molecular Remission Induced by Gilteritinib Plus VA Regimen in Newly Diagnosed Intermediate-Risk Fit AML Patients With FLT3-ITD Mutation","GANCE","Inclusion Criteria:\n\n* Each subject (or their legal representative) must sign an informed consent form (ICF) before any specific study procedures or tests, indicating that he\u002Fshe understands the purpose and procedures of the study and is willing to participate.\n* Age ≥ 18 years or reaching the legal minimum adult age (whichever is greater) and ≤ 60 years (at screening);\n* Newly diagnosed acute myeloid leukemia with FLT3-ITD mutation according to the European LeukemiaNet (ELN) 2022 diagnostic criteria (no VAF requirement), with no low-risk or high-risk genetic features as defined by ELN 2022.\n* ECOG performance status ≤ 2. Biochemical indicators must be within the following limits within 21 days before randomization and at baseline: ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 3× ULN; serum creatinine ≤ 2× ULN or CrCl ≥ 40 mL\u002Fmin. LVEF determined by echocardiography is within the normal range (LVEF \\> 50%).\n\nExclusion Criteria:\n\n* Diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive acute myeloid leukemia, or AML secondary to previous chemotherapy or radiotherapy.\n* History of other malignancies, except for adequately treated non-malignant skin melanoma, cured in situ tumors, or other solid tumors that have been treated and have had no evidence of disease for at least 2 years.\n* Assessed as unfit for intensive chemotherapy based on the following criteria: ECOG performance status ≥ 2 at screening; severe cardiac diseases (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina); severe pulmonary diseases (e.g., DLCO ≤ 65% or FEV1 ≤ 65%); creatinine clearance \\\u003C 45 ml\u002Fmin (calculated by Cockcroft-Gault equation), liver disease with total bilirubin \\> 1.5 times the normal upper limit (ULN); any other comorbidities deemed incompatible with intensive chemotherapy by the attending physician.\n* Uncontrolled fungal, bacterial, or viral infections.\n* Known active clinically relevant liver disease (e.g., active hepatitis B or C); known history of HIV infection (participants should undergo HIV testing before randomization).\n* History of allergy to any excipients in gilteritinib tablets.\n* Pregnant or breastfeeding women.\n* Other conditions deemed unsuitable for this study by the investigator.","59 Years",{"count":7,"type":24},[90],"This clinical trial aims to evaluate whether molecular MRD-guided chemotherapy can effectively treat FLT3-ITD mutated AML and potentially replace allogeneic hematopoietic stem cell transplantation. It primarily seeks to answer:\n\n* What is the complete remission rate after initial induction with Gilteritinib, Venetoclax, and Azacitidine?\n* What are the survival rates and safety of subsequent high-dose cytarabine consolidation after two cycles of this induction therapy? As a single-arm study, outcomes will be compared against historical data from standard treatments (including transplant) to assess if the new strategy is equally or more effective.\n\nParticipants will:\n\n* Undergo three cycles of high-dose cytarabine consolidation after two cycles of induction therapy, contingent upon achieving deep FLT3-ITD molecular remission.\n* Start Gilteritinib maintenance therapy after consolidation if FLT3-ITD remains detectable, continuing until deep molecular remission is achieved again.",[591,592,593,594],"Acute Myeloid Leukemia","FLT3 Internal Tandem Duplication Positive","Intermediate Risk Acute Myeloid Leukemia","Fit Patients",[596,597,598,599,600,601],"acute myeloid leukemia","FLT3-ITD","Intermediate Risk","Fit","Gilteritinib","Deep molecular remission","2026-02-02",{"date":604,"type":39},"2026-02-04",{"date":606,"type":39},"2026-01-25",{"date":608,"type":24},"2029-12-31",{"name":45,"class":46},{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":25,"phases":619,"briefSummary":620,"conditions":621,"keywords":625,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":639},"100606180","phase-2-alternating-regimen-of-va-and-low-dose-cha-in-the-treatment-of-unfit-newly-diagnosed-aml-100606180","NCT07172204","Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML","The Efficacy and Safety of VA Alternating With Low-dose CHA in the Treatment of Newly Diagnosed Unfit AML: a Prospective, Multi-centers, Single Arm Phase II Study","CHANCE","Inclusion Criteria:\n\n* Understand the research and sign a written informed consent form;\n* Be newly diagnosed with AML according to WHO 2022 criteria without prior treatment;\n* or unwilling to undergo IC. Ineligibility for IC is defined as meeting any of the following criteria:\n* Age ≥ 60 years\n* Age 18-59 years but ineligible for intensive chemotherapy (IC) , meet ≥1 of the following:\n\n  * Eastern Cooperative Oncology Group (ECOG) performance status ≥2 at screening;\n  * Severe heart failure (congestive heart failure requiring treatment or myocardial infarction history with ejection fraction ≤50%);\n  * Severe pulmonary dysfunction (DLCO ≤65%, FEV1 ≤65%, dyspnea at rest, or oxygen dependence);\n  * Severe renal insufficiency requiring dialysis;\n  * Child-Pugh B or C cirrhosis, or hepatic impairment with total bilirubin \\>1.5×ULN;\n* Mental illness requiring inpatient psychiatric treatment;\n* Any comorbidity deemed by physician to contraindicate IC.\n\nExclusion Criteria:\n\n* Diagnosis of: AML arising from chronic myeloid leukemia (CML); myeloid sarcoma; acute promyelocytic leukemia (APL) or presence of FLT3-ITD mutations;\n* Active malignancies (except adequately treated carcinoma in situ or basal cell carcinoma) within 2 years prior to Cycle 1 Day 1 (C1D1);\n* Major surgery or systemic anticancer therapy within 28 days before C1D1;\n* Known hypersensitivity to: Active pharmaceutical ingredients: cladribine, homoharringtonine, cytarabine, venetoclax, azacitidine; Any excipients in study drug formulations;\n* GI conditions impairing oral drug absorption: Dysphagia; short-gut syndrome; gastroparesis or related disorders;\n* Uncontrolled active infection;\n* Controlled infection permitted if: Afebrile (\\\u003C38°C) and hemodynamically stable (SBP \\>90 mmHg, HR \\\u003C100 bpm) for ≥72 hours pre-C1D1; on non-interacting antimicrobial regimen; active HBV\u002FHCV infection (Chronic carriers require PI approval with viral load monitoring); HIV-positive patients receiving HAART;\n* Pregnancy\u002Flactation or refusal of contraception: Negative serum β-hCG within 24h pre-C1D1;\n* Psychiatric disorders or social circumstances compromising protocol compliance;\n* Prior AML-directed therapy except: cytoreduction for hyperleukocytosis per institutional guidelines (hydroxyurea, leukapheresis); supportive growth factors;",{"count":7,"type":24},[90],"This phase II trial tests how well VA alternating with low-dose CHA works in treating unfit patients with newly diagnosed acute myeloid leukemia (AML). This is a prospective, multi-centers, single arm phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.",[622,623,624],"Intensive Chemotherapy Unfit","Newly Diagnosed Acute Myeloid Leukemia (AML)","Age ≥60",[591,626,627,628,629,630,631,632],"Venetoclax","alternating","Homoharringtonine","Cladribine","age 60 and older","intensive chemotherapy unfit","newly diagnosed",{"date":604,"type":39},{"date":635,"type":39},"2025-09-16",{"date":637,"type":24},"2029-07-31",{"name":45,"class":46},5,""]