[{"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:":641},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,110,0,25,[9,47,78,105,132,158,183,216,244,273,297,319,337,366,386,405,423,443,470,492,518,546,569,592,617],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100652453","phase-3-chidamide-maintenance-to-prevent-relapse-after-allogeneic-hematopoietic-stem-cell-transplantation-in-acute-t-lymphoblastic-leukemialymphoma-100652453",false,"NCT07774377","Chidamide Maintenance to Prevent Relapse After Allogeneic Hematopoietic Stem Cell Transplantation in Acute T-Lymphoblastic Leukemia\u002FLymphoma","Chidamide Maintenance to Prevent Relapse After Allogeneic HSCT in Acute T-Lymphoblastic Leukemia\u002FLymphoma: A Multicenter Randomized Controlled Trial","CHI-HSCT","Inclusion Criteria:\n\n1. Age 14-70 years (inclusive).\n2. Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) according to the 2016 WHO classification, with an early T-cell precursor (ETP) phenotype defined by immunophenotypic criteria: CD1a-, CD8-, CD5 weak, with expression of one or more myeloid\u002Fstem cell markers (e.g., CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65).\n3. Have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and achieved complete remission (CR\u002FCRh\u002FCRi) with full donor chimerism (≥95% by STR or equivalent method).\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Adequate organ function:\n\n   * Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault).\n   * AST and ALT ≤3×ULN; total bilirubin ≤2×ULN (≤3×ULN for Gilbert's syndrome).\n   * Left ventricular ejection fraction (LVEF) ≥50% by echocardiography.\n6. Life expectancy \\>8 weeks.\n7. Willing and able to provide written informed consent and comply with study procedures.\n8. For women of childbearing potential: negative serum\u002Furine pregnancy test at baseline; and agreement to use highly effective contraception during treatment and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Evidence of relapse or disease progression at screening or baseline.\n2. Persistent significant myelosuppression (ANC \\\u003C1.0×10⁹\u002FL or platelets \\\u003C25×10⁹\u002FL within 7 days without transfusion support) unrelated to reversible causes.\n3. Active grade 3-4 acute GVHD, or acute GVHD requiring systemic corticosteroids ≥0.5 mg\u002Fkg\u002Fday prednisone equivalent to control; or active moderate-severe chronic GVHD not well controlled by standard therapy.\n4. Active autoimmune disease requiring systemic immunosuppression.\n5. Clinically significant cardiovascular disease: uncontrolled arrhythmia, QTc prolongation \\>470 ms (males) or \\>480 ms (females), uncontrolled hypertension ≥160\u002F100 mmHg, NYHA class III-IV heart failure, or acute myocardial infarction\u002Funstable angina within 6 months.\n6. Uncontrolled infections or other severe medical conditions that would increase study risk.\n7. Uncontrolled chronic viral infections: HIV positive; HBV (HBsAg positive with HBV-DNA \\>ULN or not on antiviral therapy); HCV (anti-HCV positive with HCV RNA \\>ULN or not on antiviral therapy).\n8. Pregnancy or breastfeeding, or unwillingness to use effective contraception.\n9. Gastrointestinal disorders affecting oral drug absorption.\n10. Inability to understand or comply with study requirements.\n11. Use of other HDAC inhibitors or investigational anticancer agents within 14 days prior to randomization; use of strong CYP inducers\u002Finhibitors that may significantly alter chidamide exposure; or live vaccination within 4 weeks before baseline.","ALL","14 Years","70 Years",{"count":22,"type":23},132,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","This study evaluates whether chidamide maintenance therapy can effectively reduce the risk of relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with high-risk T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL\u002FLBL). Chidamide is an oral selective histone deacetylase inhibitor (HDACi) with dual anti-tumor and immunomodulatory effects.\n\nParticipants will be randomized in a 1:1 ratio to receive either chidamide maintenance for up to 24 months or standard follow-up without maintenance. The primary endpoint is relapse-free survival (RFS). Key secondary endpoints include cumulative incidence of relapse (CIR), overall survival (OS), non-relapse mortality (NRM), incidence and severity of graft-versus-host disease (GVHD), safety profile, and patient-reported outcomes (PROs).\n\nThis multicenter, open-label, randomized controlled trial aims to provide high-level evidence on the efficacy and safety of chidamide as a post-transplant maintenance strategy. Approximately 132 patients will be enrolled across 6 transplant centers in China.",[29,30],"T-Cell Acute Lymphoblastic Leukemia","T-Cell Lymphoblastic Lymphoma",[32,33,34],"Chidamide","T-cell acute lymphoblastic leukemia","T-cell lymphoblastic lymphoma","NOT_YET_RECRUITING","2026-08-18",{"date":38,"type":39},"2026-08-19","ACTUAL",{"date":41,"type":23},"2026-08-15",{"date":43,"type":23},"2029-08-15",{"name":45,"class":46},"First Affiliated Hospital of Zhejiang University","OTHER",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":18,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100604771","an-observational-study-on-lecanemab-treatment-for-early-alzheimers-disease-100604771","NCT07153848","An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease","A Multicenter Cohort Study for Early Alzheimer's Disease in Zhejiang: an Observational Study on Lecanemab Treatment","Inclusion criteria (all of the following must be met simultaneously):\n\nMild Alzheimer's Disease (AD):\n\n1. Age ≥ 45 years but ≤ 85 years;\n2. Literacy level of elementary school and above (i.e., ≥3 years of education);\n3. Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition);\n4. Clinical Dementia Rating Scale CDR-global = 1 point;\n5. Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain.\n\nAD-derived mild cognitive impairment (aMCI) inclusion criteria (must meet all of the following conditions at the same time):\n\n1. Age: 45 years or older but ≤85 years;\n2. Literacy level elementary school and above (i.e., ≥3 years of education);\n3. Meeting Peterson's 2004 diagnostic criteria for MCI:\n\n   (i) Complaint of memory impairment that can be confirmed by an informed person; (ii) objective evidence of memory impairment (memory test scores 1-1.5 standard deviations below normal controls matched for age and literacy; e.g., Huashan Hospital's recommended cut-off values for those with elementary school literacy or above are as follows: long-delayed recall 50-59 years old ≤ 5, 60-69 years old ≤ 4, 70-79 years old ≤ 3, 80-89 years old ≤ 2, or re-recognition scores of 50-59 years old ≤ 20, 60-69 age ≤19 points, 70-79 years ≤18 points, 80-89 years ≤16 points); (iii) Overall cognitive functioning was largely preserved, with CDR-global = 0.5 points and MMSE: ≥24 points for those with junior high school or higher education used in this study;\n\n   ④ Daily life ability remains normal (basically able to complete going out by transportation and shopping and counting, etc.);\n\n   ⑤ Does not meet the International Classification of Diseases Diagnostic Manual, 10th edition dementia criteria (for research purposes) and the National Institute of Neurological and Speech-Language Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) likely diagnostic criteria for AD dementia; (vi) Aβ-PET scan suggested extensive deposition of Aβ plaques in the brain.\n\nNormal control Inclusion criteria (all of the following must be met simultaneously).\n\n1. Age ≥55 years but ≤85 years;\n2. Elementary school 3 years of education and above;\n3. MMSE: ≥26 points for those with junior high school or higher education;\n4. CDR=0;\n5. Activity of Daily Living Scale (ADL) score ≤ 20;\n6. No significant deposition of Abeta in the brain as indicated by Aβ-PET scan.\n\nExclusion Criteria (excluded if any of the following conditions were met):\n\n1. Those with a history of stroke and neurologic focal signs, head MRI scans excluding external infarct foci, brain softening foci and other occupying lesions, etc., as well as SWI sequences showing 5 or more microhemorrhagic foci, vascular malformations, etc;\n2. Presence of other neurological disorders that may cause brain dysfunction (e.g., schizophrenia, severe anxiety and depression, frontotemporal lobe dementia, Huntington's disease, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, and normal cranial pressure hydrocephalus, etc.);\n3. Presence of other systemic diseases that can cause cognitive impairment, such as hypothyroidism, folic acid and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse;\n4. Presence of a history of severe hepatic or renal insufficiency, severe pulmonary insufficiency, severe anemia, severe gastrointestinal disorders, severe cardiac arrhythmias, cardiac infarction within 6 months, and malignant tumors;\n5. Oral anticoagulants (including warfarin and new oral anticoagulants, etc.);\n6. Presence of contraindications to NMR such as metal implantation in the body;\n7. Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination;\n8. Refusal to sign the informed consent.",true,"45 Years","85 Years",{"count":58,"type":23},400,"18 Months","OBSERVATIONAL","The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.",[63],"Alzheimer Disease",[65,63,66,67],"lecanemab","biomarkers","blood","RECRUITING","2026-07-30",{"date":71,"type":39},"2026-07-31",{"date":73,"type":39},"2024-07-01",{"date":75,"type":23},"2027-12-31",{"name":45,"class":46},2,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":54,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100649363","microbiome-and-enteric-signatures-in-sepsis-associated-hepatorenal-injury-100649363","NCT07735182","Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury","The Impact of Gut Microbiota on Sepsis-Associated Acute Hepatorenal Injury: A Prospective, Multicenter, Observational Study","MESH","Inclusion Criteria:\n\n\\-\n\nFor Sepsis Patients:\n\n1. Age ≥ 18 years；\n2. Admitted to the Intensive Care Unit (ICU) and meets the Sepsis-3 diagnostic criteria (an acute change in total Sequential Organ Failure Assessment \\[SOFA\\] score ≥ 2 points consequent to the infection).\n3. Diagnosed with sepsis within 24 hours prior to enrollment.\n4. Informed consent signed by the patient or a legally authorized representative.\n\nFor Healthy Volunteers:\n\n1. Age ≥ 18 years.\n2. No chronic underlying diseases (including liver, kidney, gastrointestinal, or immune-related disorders).\n3. No use of antibiotics or probiotics, and no history of acute infection within 1 month prior to enrollment (to ensure baseline consistency).\n4. Informed consent signed by the volunteer.\n\nExclusion Criteria:\n\n1. History of chronic liver disease (e.g., cirrhosis, chronic hepatitis B\u002FC, autoimmune hepatitis, hepatic carcinoma).\n2. History of chronic kidney disease (e.g., glomerulonephritis, IgA nephropathy).\n3. History of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or previous major intestinal resection.\n4. Patients with malignant tumors currently receiving chemotherapy or radiotherapy.\n5. Expected survival time of less than 72 hours.\n6. Pregnant or lactating women.\n7. Concurrent participation in other interventional clinical trials.","18 Years",{"count":88,"type":23},200,"Sepsis is a major cause of morbidity and mortality in intensive care units. Sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) are common complications associated with adverse clinical outcomes. Altered gut microbial diversity, microbial metabolites, intestinal barrier dysfunction, and systemic inflammation may contribute to hepato-renal injury during sepsis; however, prospective longitudinal evidence in patients with SALI and S-AKI remains limited.\n\nThis prospective, multicenter, longitudinal observational cohort study will enroll adult patients with sepsis across five medical centers and healthy adult volunteers as a baseline reference cohort. For patients with sepsis, stool and blood samples will be collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Healthy volunteers will provide a single baseline stool and blood sample at enrollment. Fecal microbial alpha diversity and community structure will be assessed by metagenomic sequencing and bioinformatic analysis. Plasma metabolites, including total short-chain fatty acids, indoxyl sulfate, and additional targeted plasma metabolites, will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry. Intestinal barrier and clinical biomarkers will also be assessed.\n\nThe primary objectives are to evaluate the associations between baseline fecal microbial alpha diversity, measured by the Shannon diversity index, and SALI and S-AKI occurring within 7 days after sepsis diagnosis. Secondary objectives include evaluating the associations of baseline fecal microbial beta diversity with SALI and with S-AKI occurring within 7 days after sepsis diagnosis, characterizing longitudinal changes in fecal microbial alpha diversity, measuring plasma metabolite and intestinal biomarker concentrations at prespecified time points, and assessing 28-day all-cause mortality. Exploratory multi-omics analyses will evaluate Proteobacteria and additional microbial taxa, microbial functional genes, metabolites, and host biomarkers. This study aims to identify candidate biomarkers and biological pathways relevant to hepato-renal injury in sepsis.",[91,92,93,94,95],"Sepsis","Acute Kidney Injury Due to Sepsis","Gastrointestinal Microbiome","Sepsis-Associated Liver Injury","Intensive Care Medicine","2026-07-28",{"date":98,"type":39},"2026-07-29",{"date":100,"type":39},"2026-02-15",{"date":102,"type":23},"2028-02-14",{"name":45,"class":46},1,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":112,"maxAge":20,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":104},"100648387","a-study-on-the-combination-of-tongluo-huayu-formula-in-treating-rvo-of-phlegm-stasis-intertwinement-type-based-on-the-mechanism-of-systemic-metabolic-regulation-mediated-by-gut-microbiota-100648387","NCT07718503","A Study on the Combination of Tongluo Huayu Formula in Treating RVO of Phlegm-Stasis Intertwinement Type: Based on the Mechanism of Systemic Metabolic Regulation Mediated by Gut Microbiota","A Study on the Combination of Tongluo Huayu Formula in Treating Retinal Vein Occlusion of Phlegm-Stasis Intertwinement Type: Based on the Mechanism of Systemic Metabolic Regulation Mediated by Gut Microbiota","Inclusion Criteria:\n\n* Patients who meet the aforementioned Western diagnostic criteria and TCM syndrome differentiation criteria for RVO, and are complicated with macular edema.\n* Patients who fully understand the study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients currently participating in other clinical trials or receiving concomitant use of similar traditional Chinese medicines or other therapies.\n* Patients with other fundus retinal diseases, such as neovascular glaucoma or iris neovascularization.\n* Patients with severe systemic diseases, such as rheumatism or systemic lupus erythematosus.\n* Women who are pregnant or breastfeeding (lactating).\n* Patients with severe cardiovascular or cerebrovascular diseases, or those with severely impaired hepatic or renal function.","40 Years",{"count":114,"type":23},80,[116],"NA","The goal of this clinical trial is to evaluate the synergistic efficacy and safety of the Tongluo Huayu Formula combined with conventional Western medical treatment for RVO, thereby providing high-quality evidence to support its subsequent clinical promotion and application.\n\nThe control group will receive conventional Western medical therapy, including laser photocoagulation and intravitreal Conbercept injection. Specifically, Conbercept will be injected intravitreally once a month for 3 consecutive months. If large areas of retinal non-perfusion or fundus neovascularization occur during the study period, laser photocoagulation will be administered based on the patient's condition. The experimental group will receive the Tongluo Huayu Formula in addition to the standard therapy provided to the control group. The Tongluo Huayu Formula will be administered for 1 month. Relevant examinations and assessments for participants in both groups will be conducted at baseline (before treatment), and at 1, 2, 3, and 6 months after treatment.",[119],"Retinal Vein Occlusion",[121,122,123],"Tongluo Huayu Formula","Conbercept","Traditional Chinese Medicine","2026-07-17",{"date":126,"type":39},"2026-07-22",{"date":128,"type":23},"2026-06",{"date":130,"type":23},"2028-12-31",{"name":45,"class":46},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":24,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100647346","phase-2-safety-and-efficacy-of-eculizumab-in-high-risk-ta-tma-100647346","NCT07707687","Safety and Efficacy of Eculizumab in High-risk TA-TMA","The Safety and Efficacy of Eculizumab for High-risk Transplant-associated Thrombotic Microangiopathy.","Inclusion Criteria:\n\n* Age ≥18 years.\n* Patients who have undergone hematopoietic stem cell transplantation for any indication within 12 months prior to enrollment.\n* Meet the diagnostic criteria for TA-TMA within ≤14 days prior to enrollment (at least 4 of the following 7 criteria present simultaneously):① Lactate dehydrogenase (LDH) above the age-adjusted upper limit of normal;② Presence of schistocytes on peripheral blood smear;③ New-onset thrombocytopenia or requirement for platelet transfusions;④ New-onset anemia or requirement for red blood cell transfusions;⑤ Hypertension;⑥ Random urine protein-to-creatinine ratio (rUPCR) ≥1 mg\u002Fmg;⑦ Elevated plasma soluble C5b-9 (sC5b-9) level (≥244 ng\u002FmL).\n* Meet the criteria for high-risk TA-TMA (presence of any of the following):① Proteinuria (rUPCR ≥2 mg\u002Fmg);②Multiple organ dysfunction syndrome (MODS);③ Elevated IL-10 (≥2× upper limit of normal \\[ULN\\]).\n* Meet the following condition: TA-TMA has not resolved after ≥72 hours of management of triggering factors\u002Fconditions, including: ① Discontinuation or dose reduction of inciting medications (e.g., calcineurin inhibitors, CNI); ② Treatment of any underlying infection; ③ Treatment of underlying acute graft-versus-host disease (aGVHD).\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity to eculizumab.\n* Uncontrolled severe infection (including meningococcal infection).\n* Prior treatment with complement inhibitors.\n* Known hereditary or acquired ADAMTS13 deficiency (activity \\\u003C10%).\n* Disseminated intravascular coagulation (DIC).\n* Respiratory failure (any cause) requiring mechanical ventilation, occurring within 72 hours prior to enrollment.\n* Acute and\u002For chronic heart failure with ejection fraction ≤40%.\n* Expected survival \\\u003C48 hours.\n* Any subject who, in the investigator's opinion, is not suitable for participation in this study.",{"count":140,"type":23},24,[142],"PHASE2","High-risk, complement-mediated, untreated transplant-associated thrombotic microangiopathy (hrTA-TMA) carries a very poor prognosis due to multiple organ dysfunction syndrome (MODS). The complement C5 inhibitor eculizumab has shown promising efficacy in children with hrTA-TMA, but has not been prospectively studied in adult allogeneic hematopoietic stem cell transplantation (HSCT) recipients. The investigators plan to conduct the first multicenter prospective study in adults to evaluate eculizumab as an early targeted intervention for hrTA-TMA. The investigators hypothesize that eculizumab will more than double the survival rate of hrTA-TMA in adult HSCT recipients compared with untreated hrTA-TMA patients from our previous study, who will serve as historical controls. Inclusion criteria are a confirmed diagnosis of TA-TMA with at least one of the following hrTA-TMA features: random urine protein-to-creatinine ratio (rUPCR) ≥2 mg\u002Fmg, multiple organ dysfunction syndrome (MODS), or elevated plasma IL-10 (≥2× upper limit of normal). The primary endpoint is survival at 6 months after diagnosis of hrTA-TMA. Secondary endpoints are the cumulative incidence of MODS at 6 months after diagnosis of hrTA-TMA, and 1-year post-transplant survival. The eculizumab regimen consists of an intensive loading dose, an induction dose, and a maintenance dose, with a total treatment duration of up to 24 weeks. This study aims to investigate the safety and efficacy of eculizumab in the treatment of high-risk TA-TMA.",[145],"Transplant-Associated Thrombotic Microangiopathy (TA-TMA)",[147,148,149],"transplant-associated thrombotic microangiopathy (TA-TMA)","allogeneic hematopoietic stem cell transplantation","Eculizumab","2026-07-16",{"date":124,"type":39},{"date":153,"type":23},"2026-07-10",{"date":155,"type":23},"2028-07-10",{"name":45,"class":46},8,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":24,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":182,"locationsCount":157},"100646356","phase-3-single-dose-vs-divided-dose-g-csf-for-stem-cell-mobilization-in-healthy-allogeneic-donors-100646356","NCT07692841","Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors","Randomized Controlled Trial Comparing Single-dose and Divided-dose G-CSF for Peripheral Blood Stem Cell Mobilization in Healthy Donors for Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Age 18-65 years.\n2. Provision of written informed consent.\n3. White blood cell (WBC) count \\> 2.5 × 10⁹\u002FL.\n4. Absolute neutrophil count (ANC) \\> 1.5 × 10⁹\u002FL and platelet count \\> 100 × 10⁹\u002FL.\n5. Deemed suitable as a donor by the investigator based on donor physical examination and HLA matching.\n6. Body weight ≥ 40 kg for females and ≥ 45 kg for males.\n\nExclusion Criteria:\n\n1. Currently having any disease or condition that, in the judgment of the investigator, would make the donor unsuitable for participation in this study, such as severe neurological, hepatic, renal, endocrine, cardiovascular, hematologic, gastrointestinal, respiratory, or metabolic diseases; malignancies; myeloproliferative disorders; or psychiatric illnesses.\n2. Currently having an active infection requiring systemic therapy.\n3. Allergy to the study drug.\n4. Presence of a malignant tumor.\n5. Untreated HBV infection with HBV-DNA above the lower limit of detection.\n6. HIV infection.\n7. Addition of any new medication within 2 weeks prior to entry into this study.\n8. Female donors who are pregnant or breastfeeding.","65 Years",{"count":167,"type":23},560,[26],"National and international guidelines\u002Fconsensus recommend G-CSF (granulocyte colony-stimulating factor) at 10 μg\u002Fkg\u002Fday as a single daily dose or divided into two daily doses for mobilization in healthy donors for allogeneic hematopoietic stem cell transplantation. However, there is no consensus or standard regarding single versus divided dosing, and high-quality evidence is lacking. Existing randomized controlled trials have small sample sizes and inconsistent conclusions, and none have focused on Asian population characteristics (e.g., body weight and drug metabolism differences). This study aims to provide level I evidence to optimize donor experience and define the optimal administration strategy.\n\nInclusion criteria: Healthy allogeneic stem cell donors aged 18-60 years, meeting institutional standard donor screening criteria (HLA matching, normal blood counts, normal liver and kidney function, negative infection screening), and providing written informed consent.\n\nPrimary endpoint: The rate of achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells\u002Fkg (donor body weight) after 5 days of G-CSF mobilization.\n\nSecondary endpoints: The rate of achieving ≥ 2 × 10⁶ CD34⁺ cells\u002Fkg with at most one apheresis; time to myeloid, platelet, and erythroid engraftment in recipients; the proportion and composition of immune cells (CD34⁺, CD3⁺, CD19⁺, CD56⁺, etc.) in the apheresis product; donor adverse events; donor-reported outcomes; and the difference in CD34⁺ stem cell yields between single-dose and divided-dose mobilization.\n\nIntervention: G-CSF will be administered at a total dose of 10 μg\u002Fkg\u002Fday, either as a single daily injection or divided into two equal daily injections.\n\nThis study is designed to investigate whether single-dose or divided-dose G-CSF administration is superior for mobilizing healthy donors in allogeneic hematopoietic stem cell transplantation.",[171,172],"Healthy Hematopoietic Stem Cell Donor","Healthy Allogeneic Hematopoietic Stem Cell Donor",[174,175,148],"healthy allogeneic hematopoietic stem cell donor","granulocyte colony-stimulating factor (G-CSF)","2026-07-13",{"date":178,"type":39},"2026-07-15",{"date":153,"type":23},{"date":181,"type":23},"2029-07-10",{"name":45,"class":46},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":191,"maxAge":20,"enrollmentInfo":192,"targetDuration":4,"studyType":24,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":104},"100607153","ruxolitinib-plus-etanercept-vs-ruxolitinib-for-steroid-refractory-severe-acute-gvhd-100607153","NCT07184853","Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD","Prospective Multicenter Randomized Study of Ruxolitinib Plus Etanercept vs Ruxolitinib Alone for Corticosteroid-Refractory Severe Acute GVHD After Allogeneic HSCT","RESCUE","Inclusion Criteria:\n\nReceived allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source (matched sibling, matched unrelated, or haploidentical), using bone marrow, peripheral blood stem cells, or cord blood; conditioning regimen may be myeloablative, reduced-intensity, or non-myeloablative.\n\nAge between 12 and 70 years.\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n\nClinical diagnosis of grade III-IV acute graft-versus-host disease (aGVHD) according to MAGIC criteria.\n\nEvidence of neutrophil and platelet engraftment prior to study treatment (absolute neutrophil count \\>1,000\u002Fmm³ and platelet count ≥20,000\u002Fmm³ within 48 hours before study entry; growth factor support and transfusion permitted).\n\nDiagnosis of steroid-refractory aGVHD, defined as one of the following:\n\nDisease progression after 3-5 days of methylprednisolone 2 mg\u002Fkg\u002Fday (or equivalent).\n\nNo improvement after 7 days of methylprednisolone 2 mg\u002Fkg\u002Fday (or equivalent).\n\nProgression from grade II to grade III-IV aGVHD after 3-5 days of methylprednisolone 1 mg\u002Fkg\u002Fday (or equivalent).\n\nAble to take oral medication.\n\nExpected survival \\>8 weeks.\n\nWomen of childbearing potential must have a negative serum β-HCG test prior to enrollment; both male and female participants of reproductive potential must agree to use effective contraception during the study and for 3 months after study completion.\n\nVoluntary written informed consent provided and ability to comply with study procedures.\n\nExclusion Criteria:\n\nPrior systemic treatment for aGVHD other than corticosteroids with or without calcineurin inhibitors (CNI); prophylactic use of MTX, MMF, or CD25 monoclonal antibody is permitted.\n\nClinical features consistent with de novo chronic GVHD or overlap syndrome (per Jagasia 2015).\n\nUncontrolled active infection, including severe bacterial, fungal, viral, or parasitic infection. Patients on appropriate treatment without evidence of progression may be eligible.\n\nEvidence of active tuberculosis.\n\nKnown HIV infection.\n\nRelapse of primary malignancy or post-transplant lymphoproliferative disorder.\n\nSevere respiratory disease, including mechanical ventilation or resting oxygen saturation \\\u003C90%.\n\nRenal dysfunction: serum creatinine \\>2.0 mg\u002FdL, requirement for dialysis, or creatinine clearance \\\u003C30 mL\u002Fmin (Cockcroft-Gault).\n\nActive hepatitis B infection (HBsAg positive with HBV DNA ≥1×10³ IU\u002FmL) or active hepatitis C infection (HCV antibody positive with detectable HCV RNA above normal).\n\nClinically significant or uncontrolled cardiac disease, including recent myocardial infarction, uncontrolled hypertension, NYHA class III\u002FIV heart failure, unstable angina, or clinically significant arrhythmia (e.g., sustained ventricular tachycardia, second- or third-degree AV block).\n\nCholestatic disease or unresolved hepatic veno-occlusive disease not attributed to aGVHD.\n\nHistory of progressive multifocal leukoencephalopathy (PML).\n\nPrior exposure to JAK inhibitors after allo-HSCT.\n\nParticipation in another investigational drug trial within 30 days or within 5 half-lives of the investigational drug (whichever is longer).\n\nPrior history of grade ≥3 non-hematologic adverse events attributable to ruxolitinib or etanercept.\n\nAny condition judged by the investigator to place the patient at undue risk or interfere with study participation.\n\nKnown hypersensitivity or intolerance to systemic immunosuppressive agents.\n\nPregnant or breastfeeding women.","12 Years",{"count":193,"type":23},122,[116],"This is a prospective, multicenter, randomized controlled trial designed to evaluate whether the combination of ruxolitinib and etanercept provides superior efficacy compared with ruxolitinib monotherapy in patients with severe corticosteroid-refractory acute graft-versus-host disease (SR-aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nAcute graft-versus-host disease (aGVHD) is one of the most common and life-threatening complications following allo-HSCT. Although corticosteroids remain the standard first-line treatment, many patients do not respond adequately. For patients with severe steroid-refractory aGVHD, the prognosis is extremely poor, with high short-term mortality and very low long-term survival.\n\nRuxolitinib, a JAK1\u002F2 inhibitor, has been approved for the treatment of SR-aGVHD, but response rates remain suboptimal, particularly in patients with gastrointestinal involvement. Etanercept, a tumor necrosis factor-alpha (TNF-α) inhibitor, has shown activity in GVHD by targeting inflammatory pathways. Previous observational studies from our center suggested that combining ruxolitinib with etanercept may improve response rates, especially in gastrointestinal and hepatic GVHD, without significantly increasing relapse risk.\n\nIn this trial, approximately 122 patients with grade III-IV SR-aGVHD will be randomized 1:1 to receive either ruxolitinib alone or ruxolitinib plus etanercept. The primary endpoint is the overall response rate (ORR) at day 28. Secondary endpoints include durable response, best overall response, failure-free survival, overall survival, cumulative incidence of relapse, non-relapse mortality, incidence of chronic GVHD, and safety outcomes.\n\nThis study seeks to provide new clinical evidence for an optimized treatment strategy for patients with severe SR-aGVHD, aiming to improve outcomes in this high-risk population.",[197],"Graft vs Host Disease",[199,200,201,202,203,204,205,206,207],"Ruxolitinib","Etanercept","JAK1\u002F2 inhibitor","TNF-α inhibitor","Corticosteroid-refractory GVHD","Severe aGVHD","Allo-HSCT complications","Graft-versus-Host Disease treatment","Immunosuppression","2026-07-04",{"date":210,"type":39},"2026-07-07",{"date":212,"type":39},"2025-09-25",{"date":214,"type":23},"2028-09-25",{"name":45,"class":46},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":54,"sex":18,"minAge":86,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":24,"phases":227,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},"100625522","chrono-mobilize-chronotherapy-of-g-csf-for-cd34-mobilization-in-healthy-donors-100625522","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","55 Years",{"count":226,"type":23},160,[116],"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.",[230],"Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization",[232,233,234],"CD34","G-CSF","Allo-HSCT","2026-06-25",{"date":237,"type":39},"2026-06-29",{"date":239,"type":39},"2026-03-01",{"date":241,"type":23},"2027-03-30",{"name":45,"class":46},3,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":24,"phases":253,"briefSummary":255,"conditions":256,"keywords":260,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":272},"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":252,"type":23},148,[254],"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.",[257,258,259],"Albuminuria","Type 2 Diabetes Mellitus (T2DM)","Chronic Kidney Diseases",[261,262,263,264,265],"Finerenone","Nonsteroidal mineralocorticoid receptor antagonist","Urine albumin-to-creatinine ratio","KDIGO","Albuminuria regression","2026-06-19",{"date":235,"type":39},{"date":269,"type":23},"2026-07-01",{"date":75,"type":23},{"name":45,"class":46},13,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":24,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"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":282,"type":23},216,[142],"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.",[286],"Bipolar Disorder II",[288,289],"bipolar disorder II","interpersonal and social rhythm therapy","2026-06-12",{"date":292,"type":39},"2026-06-17",{"date":269,"type":23},{"date":295,"type":23},"2029-07-01",{"name":45,"class":46},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":54,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":24,"phases":306,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"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":305,"type":23},104,[307],"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",[310],"Healthy Participants Study","2026-06-05",{"date":313,"type":39},"2026-06-10",{"date":315,"type":39},"2026-06-01",{"date":317,"type":23},"2027-04-30",{"name":45,"class":46},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":165,"enrollmentInfo":325,"targetDuration":4,"studyType":24,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":335,"leadSponsor":336,"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.",{"count":326,"type":23},18,[307],"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.",[330],"HIV (Human Immunodeficiency Virus)","2026-06-03",{"date":333,"type":39},"2026-06-09",{"date":315,"type":23},{"date":130,"type":23},{"name":45,"class":46},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":24,"phases":347,"briefSummary":348,"conditions":349,"keywords":353,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"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.","75 Years",{"count":346,"type":23},30,[142],"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.",[350,351,352],"Gastric Adenocarcinoma","Esophagogastric Juction Cancer","Proficient Mismatch Repair",[354,355,356,357,358],"Gastric adenocarcinoma","Esophagogastric junction cancer","Proficient mismatch repair","Tafolecimab","Sintilimab","2026-05-27",{"date":361,"type":39},"2026-06-02",{"date":311,"type":23},{"date":364,"type":23},"2030-09-01",{"name":45,"class":46},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":344,"enrollmentInfo":373,"targetDuration":374,"studyType":60,"phases":4,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"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.",{"count":88,"type":23},"3 Months","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.",[377],"Moderate to Severe Cancer Pain",[379],"cancer pain",{"date":315,"type":39},{"date":382,"type":39},"2026-04-15",{"date":384,"type":23},"2028-03-15",{"name":45,"class":46},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":55,"enrollmentInfo":393,"targetDuration":4,"studyType":24,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"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.",{"count":226,"type":23},[116],"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.",[397],"Bipolar Depression","2026-05-25",{"date":359,"type":39},{"date":401,"type":39},"2025-05-20",{"date":403,"type":23},"2026-12",{"name":45,"class":46},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":24,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"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":413,"type":23},43,[116],"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.",[417],"Major Depressive Disorder",{"date":359,"type":39},{"date":128,"type":23},{"date":421,"type":23},"2027-06",{"name":45,"class":46},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":55,"enrollmentInfo":430,"targetDuration":4,"studyType":24,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"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":431,"type":23},70,[116],"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.",[435],"Bipolar Disorder (BD)","2026-05-24",{"date":359,"type":39},{"date":439,"type":39},"2026-04-27",{"date":441,"type":23},"2027-03-31",{"name":45,"class":46},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":280,"enrollmentInfo":450,"targetDuration":4,"studyType":24,"phases":452,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":469,"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":451,"type":23},180,[116],"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.",[455,456],"Insomnia Disorder","Sleep Initiation and Maintenance Disorders",[458,459,460,461,462],"Inulin","Spirulina","Gut Microbiota","Gut-Brain Axis","Insomnia","2026-05-15",{"date":465,"type":39},"2026-05-19",{"date":467,"type":23},"2026-05-01",{"date":317,"type":23},{"name":45,"class":46},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":165,"enrollmentInfo":476,"targetDuration":4,"studyType":24,"phases":478,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":491,"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":477,"type":23},20,[307,142],"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.",[330],[482,483,484],"HIV","CAR-NK","Functional cure","2026-05-04",{"date":487,"type":39},"2026-05-11",{"date":467,"type":23},{"date":490,"type":23},"2027-12-30",{"name":45,"class":46},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":165,"enrollmentInfo":499,"targetDuration":4,"studyType":24,"phases":501,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":517,"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":500,"type":23},88,[116],"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",[504],"Depressive Disorder",[506,507,508,461,509,510,511],"Bifidobacterium PB-18","Probiotic","Depression","Placebo-Controlled","Randomized","Double-Blind",{"date":513,"type":39},"2026-05-07",{"date":515,"type":23},"2026-05-05",{"date":317,"type":23},{"name":45,"class":46},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":524,"enrollmentInfo":525,"targetDuration":4,"studyType":24,"phases":527,"briefSummary":528,"conditions":529,"keywords":533,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":545},"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":526,"type":23},480,[26],"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).",[530,531,532],"Nutritional Deficiency","Gastrointestinal Cancers","Sarcopenia",[534,535,536],"silkworm pupa tablets","gastrointestinal malignancies","nutritional risk","2026-04-21",{"date":539,"type":39},"2026-04-28",{"date":541,"type":23},"2026-04-01",{"date":543,"type":23},"2028-03-31",{"name":45,"class":46},4,{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":553,"enrollmentInfo":554,"targetDuration":556,"studyType":60,"phases":4,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"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":555,"type":23},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.",[559,560],"Gastrectomy for Gastric Cancer","Gastric Cancer","2026-04-07",{"date":563,"type":39},"2026-04-13",{"date":565,"type":23},"2026-04-10",{"date":567,"type":23},"2028-01-31",{"name":45,"class":46},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":576,"maxAge":524,"enrollmentInfo":577,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":579,"conditions":580,"keywords":581,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":591,"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":578,"type":23},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.",[560],[582,583,584],"FAPI","PET","MRI","2026-03-31",{"date":587,"type":39},"2026-04-06",{"date":467,"type":23},{"date":590,"type":23},"2028-05-31",{"name":45,"class":46},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":344,"enrollmentInfo":599,"targetDuration":4,"studyType":24,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"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":600,"type":23},51,[142],"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.",[604,605,606,607,608],"Colorectal Carcinoma","Oligometastases","pMMR","MSS","iTNT","2026-03-22",{"date":611,"type":39},"2026-03-25",{"date":613,"type":39},"2025-04-22",{"date":615,"type":23},"2032-12",{"name":45,"class":46},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":18,"minAge":411,"maxAge":344,"enrollmentInfo":623,"targetDuration":4,"studyType":24,"phases":625,"briefSummary":626,"conditions":627,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":638,"leadSponsor":640,"locationsCount":326},"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":624,"type":23},186,[26],"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.",[628,629,630,631,632,633],"Venentoclax","Myeloid Malignancies","Conditioning","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Acute Myeloid Leucemia","Myeldysplastic Syndrome (MDS)","2026-03-16",{"date":636,"type":39},"2026-03-17",{"date":239,"type":23},{"date":639,"type":23},"2030-06-30",{"name":45,"class":46},""]