[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ruijin Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":560},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,282,0,25,[9,43,67,87,116,140,166,192,219,237,263,274,298,320,345,362,385,405,425,443,458,476,496,516,540],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100053807",false,"NCT07638813","MSC-Exosome Therapy for Frontotemporal Dementia","A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Via Intranasal Administration in Patients With Frontotemporal Dementia","Inclusion Criteria:\n\n1. Diagnosis of probable frontotemporal dementia (FTD), including behavioral variant (bvFTD), semantic variant primary progressive aphasia (svPPA), or non-fluent variant primary progressive aphasia (nfvPPA), according to established diagnostic criteria, with supportive neuroimaging evidence showing frontal and\u002For temporal lobe atrophy score of 2 or higher on brain CT or MRI.\n2. Age between 30 and 80 years (inclusive) at screening.\n3. Study partner who agrees to participate in the study, provides at least 3 hours of daily care or visits, and can manage all study medication.\n4. Frontotemporal Lobar Degeneration Clinical Dementia Rating (FTLD-CDR) score of 0-2 and Mini-Mental State Examination (MMSE) score greater than 10 at screening.\n5. Stable use of cognition- or behavior-related medications (e.g., cholinesterase inhibitors, memantine, antidepressants, antipsychotics, mood stabilizers, benzodiazepines) for at least 30 days before baseline.\n6. Signed informed consent form.\n\nExclusion Criteria:\n\n1. History of stroke or other neurological or psychiatric disorder (other than FTD) that is considered the primary cause of behavioral symptoms.\n2. Pregnancy or breastfeeding, or plan to become pregnant during the study period.\n3. Use of any investigational or experimental drug or device within 60 days or 5 half-lives (whichever is longer) prior to screening.\n4. Presence of speech or language impairment that severely affects the implementation of neuropsychological assessments or safety evaluations per the study protocol.\n5. History of cancer, unless: (a) considered cured; (b) not actively receiving anti-cancer therapy or radiation and the investigator judges that treatment is unlikely to be needed in the next 5 years; or (c) for prostate cancer or basal cell carcinoma, no significant progression in the past 2 years.\n6. Any clinically significant hematologic, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease that would interfere with study participation. Participants may be included if the condition has been stable for at least one year and the investigator judges that it does not affect participation.\n7. Known hypersensitivity to the study drug or any of its excipients.","ALL","30 Years","80 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is testing a new treatment for Frontotemporal Dementia (FTD) - a progressive brain disease that affects personality, behavior, and language. Currently, there is no cure for FTD and no approved medication that can slow down or stop the disease. Existing treatments only help manage some symptoms temporarily.\n\nThe investigational treatment in this study is made from exosomes - tiny particles naturally released by umbilical cord stem cells. Exosomes act like \"message carriers\" between cells. Researchers believe they may help protect brain cells, reduce harmful protein buildup, and improve brain function.\n\nThe exosomes will be given as a nasal spray (sprayed into the nose). This method may allow the treatment to reach the brain directly without needing to pass through the blood-brain barrier (a natural protective layer that often blocks medications from entering the brain).",[28],"Frontotemporal Dementia",[28,30],"exosomes","NOT_YET_RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-07-01",{"date":39,"type":21},"2027-10-31",{"name":41,"class":42},"Ruijin Hospital","OTHER",{"id":44,"slug":4,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100645281","NCT07680582","An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors","An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors","Key Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1\n3. Life expectancy of ≥6 months\n4. Patient diagnosed with solid tumors and is receiving perioperative and\u002For adjuvant anti-cancer therapy, or patients with advanced solid tumors\n5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention\n6. Sufficient organ function\n7. Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.\n\nKey Exclusion Criteria:\n\n1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously\n2. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer\n3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.\n4. Presence of active infections\n5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment\n6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.","18 Years",{"count":51,"type":21},60,[53],"EARLY_PHASE1","The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.",[56],"Solid Tumor",[41],"RECRUITING",{"date":60,"type":35},"2026-07-02",{"date":62,"type":35},"2026-06-09",{"date":64,"type":21},"2031-02-09",{"name":41,"class":42},1,{"id":68,"slug":4,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":66},"100645387","NCT07680595","Prospective Management of Plaque Instability With Statins and Extra Folic Acid","A Prospective, Exploratory, Cohort Clinical Study Comparing the Effects of Oral Statins With or Without Folic Acid on Carotid Plaque Stability.","PROMISE","Inclusion Criteria:\n\n* Signed and dated written informed consent form (version approved by the Ethics Committee);\n* Voluntary participation and commitment to comply with the study protocol;\n* Aged 18 to 75 years, regardless of sex;\n* Confirmed carotid plaque by ultrasound or computed tomography angiography (CTA), defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one lesion with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or plaque formation;\n* Able to cooperate and complete the 6-month study follow-up, including regular imaging examinations and blood sample collections.\n\nExclusion Criteria:\n\n* History of plaque excision or interventional procedures, such as carotid endarterectomy (CEA) or carotid artery stenting (CAS);\n* History of severe hepatic or renal impairment, malignancies, autoimmune diseases, or psychiatric disorders;\n* Pregnant or lactating women;\n* Hypersensitivity (or allergy) to any components of the study medications;\n* Current or long-term regular use of any dietary supplements or medications that may significantly affect the folate metabolic cycle (e.g., vitamin B6, vitamin B12, multivitamins, etc.).","75 Years",{"count":76,"type":21},180,[24,25],"This is a prospective, exploratory, cohort clinical study aiming to further investigate the direct impact of folic acid on the stability of carotid atherosclerotic plaques, building upon substantial clinical evidence confirming that folic acid supplementation reduces the risk of stroke in hypertensive patients, thereby providing a basis for subsequent confirmatory randomized controlled trials. The study will enroll patients with carotid plaques who have not undergone carotid endarterectomy or stent implantation, with lesions defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one site with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or visible plaque formation. Participants will be allocated into Cohort 1 (statin therapy) and Cohort 2 (statin therapy plus folic acid); Cohort 1 will receive oral atorvastatin 20 mg daily, while Cohort 2 will receive an additional oral folic acid 5 mg daily on top of the 20 mg oral atorvastatin regimen, both for a continuous duration of 6 months. Statin therapy in both groups will be standardized and managed in accordance with current clinical guidelines, and all subjects will undergo comprehensive evaluations at baseline and after the 6-month intervention. The primary endpoint is the change in carotid plaque thickness at 6 months post-treatment, while secondary endpoints encompass changes in maximum plaque diameter, analysis of plaque composition ratio, and the regulatory effects on serum metabolic markers and the peripheral immune microenvironment, alongside continuous monitoring of treatment-related adverse events throughout the study to comprehensively evaluate overall safety and tolerability.",[80],"Carotid Atherosclerotic Plaque",{"date":60,"type":35},{"date":83,"type":35},"2026-03-01",{"date":85,"type":21},"2027-12-31",{"name":41,"class":42},{"id":88,"slug":4,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":94,"minAge":49,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":66},"100633515","NCT07527689","Ultra-Hypofractionated vs Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in High Risk Breast Cancer","A Multicenter, Randomized, Controlled Phase III Clinical Trial Comparing Ultra-Hypofractionated Versus Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in Post-operative Breast Cancer","HARVEST-PRO","Inclusion Criteria:\n\n1. Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.\n2. Age ≥ 18 years.\n3. Histologically confirmed invasive breast cancer.\n4. Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy, targeted axillary dissection and\u002For axillary lymph node dissection.\n5. Tumor stage is classified as T1, T2, or T3, as defined by the AJCC Cancer Staging Manual, 8th Edition.\n6. Meeting at least one of the following conditions:\n\n   1. Pathological nodal status of pN2 or pN3a;\n   2. Pathological nodal status of pN1 with one or more of the following high-risk factors:\n\n   (I), Age \\\u003C 40 years. (II), Tumor location in the central or inner quadrant. (III), Estrogen Receptor (ER) negative. (IV), Presence of lymphovascular invasion (LVI). (V), Histological grade III. (VI), Patients presenting with clinical stage cN2-3a before neoadjuvant treatment.\n7. Pathologically negative surgical margins, defined as \"no ink on tumor.\"\n8. Karnofsky Performance Status (KPS) score ≥ 80.\n9. Documented biomarker status for Estrogen Receptor (ER), Progesterone Receptor (PR), HER2, and Ki-67.\n10. Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site.\n\nExclusion Criteria:\n\n1. Nodal stage is classified as N3b or N3c, as defined by the AJCC Cancer Staging Manual, 8th Edition.\n2. Has undergone or is planning immediate breast reconstruction with a permanent implant or tissue expander.\n3. Evidence of distant metastatic disease.\n4. Diagnosis of synchronous bilateral invasive breast cancer or a history of prior invasive cancer in either breast.\n5. History of prior radiation therapy to the chest, axillary, or supraclavicular regions.\n6. Known active collagen vascular diseases, particularly systemic lupus erythematosus or scleroderma, which are contraindications to radiotherapy.\n7. Presence of any severe, uncontrolled co-morbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results.\n8. History of any other malignancy within the 5 years before enrollment, with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.\n9. Participants who are pregnant or lactating at the time of study enrollment. (Note: In accordance with the standards of each participating institution, women of childbearing age are required to undergo pregnancy testing within 2 weeks prior to randomization.)","FEMALE",{"count":96,"type":21},1950,[98],"NA","For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.",[101],"Breast Cancer",[103,104,105,106,107],"Adjuvant Radiotherapy","regional nodal irradiation","internal mammary node irradiation","ultrahypofractionated radiation therapy","hypofractionated radiation therapy","2026-06-28",{"date":110,"type":35},"2026-06-30",{"date":112,"type":35},"2026-04-22",{"date":114,"type":21},"2039-03-30",{"name":41,"class":42},{"id":117,"slug":4,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":74,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":66},"100643153","NCT07638787","Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High\u002FDouble-Hit LBCL","A Single-Arm, Prospective Study of Pola-R-CHP Plus Sonrotoclax in Patients With Previously Untreated Large B-Cell Lymphoma (LBCL) With High BCL2 Expression \u002F Double-Hit Lymphoma","Inclusion Criteria:\n\n* Patients with newly diagnosed large B-cell lymphoma confirmed by histopathology, CD20-positive, excluding central nervous system lymphoma;\n* Patients aged 18 to 75 years;\n* International Prognostic Index score of 2 to 5;\n* Patients with high BCL-2 expression or double-hit lymphoma characteristics;\n* No prior anti-tumor treatment of any type;\n* Estimated survival time ≥ 6 months;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;\n* Measurable lesions confirmed by radiological examination, defined as: at least one lymph node lesion with the longest diameter \\> 1.5 cm, or at least one extranodal lesion with the longest diameter \\> 1.0 cm, and at least two accurately measurable perpendicular diameters;\n* Patients or their legal representatives must provide written informed consent before conducting any study-specific examinations or procedures;\n* No prior treatment for lymphoma (except glucocorticoids).\n\nExclusion Criteria:\n\n* Prior solid organ transplantation or stem cell transplantation;\n* Complicated with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases, etc.;\n* Suspected active or latent tuberculosis (confirmed by a positive interferon-gamma release assay);\n* Any of the following abnormal laboratory test values (unless these abnormalities are all caused by the underlying lymphoma):\n* Neutrophils \\\u003C 1.0×10⁹\u002FL;\n* Platelets \\\u003C 75×10⁹\u002FL;\n* Serum AST and ALT ≥ 2.5× upper limit of normal (ULN);\n* Total bilirubin ≥ 1.5×ULN;\n* Serum creatinine clearance \\\u003C 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n* Uncontrolled or significant cardiovascular diseases, including but not limited to:\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Primary cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.;\n* Clinically significant QTc prolongation, with QTc interval \\> 470 ms (females) or 480 ms (males), second-degree type II atrioventricular block, or third-degree atrioventricular block;\n* Current or past history of central nervous system (CNS) diseases, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative diseases. However, participants with a history of stroke who have not had a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits as judged by the investigator are allowed to participate in the study;\n* Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;\n* Patients infected with human immunodeficiency virus (HIV);\n* History of other malignant tumors that may affect protocol compliance or interpretation of results:\n* Participants with a history of cured basal or squamous cell carcinoma of the skin, melanoma, or carcinoma in situ of the cervix at any time before the study are eligible to participate;\n* Participants with a history of untreated low-grade early-stage prostate cancer (Gleason score ≤ 6, Stage 1 or 2) at any time before the study are eligible to participate;\n* Participants who received adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer for ≥ 2 years before enrollment are eligible to participate;\n* Participants with any other malignant tumor cured by appropriate radical treatment and in remission without treatment for ≥ 2 years before enrollment are eligible to participate;\n* History of immune-related adverse events following prior immunotherapy drug-related treatment, as follows: known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding onychomycosis) at study enrollment, or major infections within 4 weeks before the start of Cycle 1;\n* Active hepatitis B virus (HBV) infection (positive result by PCR). For patients with positive HBsAg test results, HBV DNA test is required; if HBV DNA \\\u003C 10³ IU\u002Fml, they can be enrolled. If HBsAg test result is negative but HBcAb test is positive (regardless of HBsAb status), HBV DNA test is also required; if HBV DNA \\\u003C 10³ IU\u002Fml, they can be enrolled;\n* Positive hepatitis C test result (serological test for hepatitis C virus \\[HCV\\] antibody):\n* Eligibility to participate is only allowed if the PCR test result for HCV RNA is negative in patients with positive HCV antibody;\n* Participants with a history of progressive multifocal leukoencephalopathy (PML);\n* Currently pregnant or breastfeeding, or planning to become pregnant during the study or within 12 months after the last dose;\n* Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.",{"count":123,"type":21},40,[24,25],"This is a Phase I\u002FII study. The Phase I part will evaluate the safety and tolerability of sonrotoclax in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP), using a standard 3+3 dose-escalation design, to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). The Phase II part will assess the efficacy of the combination regimen in patients with previously untreated LBCL with high BCL2 expression or MYC\u002FBCL2 rearrangements.",[127],"Large B-cell Lymphoma",[129,130,131,132],"LBCL","BCL2","DHL","Sonrotoclax","2026-06-25",{"date":110,"type":35},{"date":136,"type":21},"2026-06-15",{"date":138,"type":21},"2029-04-30",{"name":41,"class":42},{"id":141,"slug":4,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100644150","NCT07664787","Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study","Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study","STAR","Inclusion Criteria:\n\n1. Male or female, aged 18 to 65 years inclusive\n2. Hypertension duration longer than 3 months\n3. Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic\u002Fdiastolic blood pressure still ≥140\u002F90 mmHg and \\\u003C160\u002F100 mmHg, and 24-hour ambulatory mean systolic \u002Fdiastolic pressure ≥130\u002F80 mmHg and \\\u003C140\u002F90 mmHg;\n4. The subject or his\u002Fher legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or planning pregnancy during the study.\n2. Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter \\\u003C3 mm, or treatable segment length \\\u003C20 mm).\n3. Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR\\\u003C40mL\u002Fmin\u002F1.73m2。\n4. Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma\u002Fparaganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).\n5. Allergic to contrast agents.\n6. Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.\n7. Orthostatic hypotension.\n8. Type 1 diabetes mellitus.\n9. History of bleeding diathesis and haematological disorders or coagulopathy\n10. History of thromboembolic event within 6 months.\n11. History of stroke or transient ischemic attack (TIA) within 6 months.\n12. Severe peripheral arterial disease or unstable abdominal aortic aneurysm.\n13. Severe valvular heart disease or anticipated need for surgical valve replacement during the study period. NYHA Class III\u002FIV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.\n14. History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.\n15. Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.\n16. Acute or severe systemic infection.\n17. Other conditions deemed unsuitable for participation by the investigator.","65 Years",{"count":149,"type":21},20,[98],"Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.",[153,154],"Hypertension","Grade 1",[156,157,158],"hypertension","renal denervation","grade I","2026-06-23",{"date":161,"type":35},"2026-06-24",{"date":37,"type":21},{"date":164,"type":21},"2027-12-30",{"name":41,"class":42},{"id":167,"slug":4,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":66},"100644736","NCT07672964","CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation","CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study","CD45RADLIPx","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Patients undergoing allogeneic hematopoietic stem cell transplantation (any conditioning regimen or graft source is allowed).\n* Presence of at least one high-risk factor for post-transplant viral infection (any of the following):\n* Age ≥50 years or ≤14 years\n* Non-sibling matched transplantation\n* In vivo or ex vivo T-cell depletion\n* Myeloablative conditioning\n* Conditioning containing radiotherapy\n* Second transplantation\n* CMV IgG or EBV IgG donor\u002Frecipient mismatch (donor positive, recipient negative)\n* History of grade II or higher acute graft-versus-host disease (aGVHD) after transplantation and use of high-dose corticosteroids (prednisone equivalent ≥1 mg\u002Fkg\u002Fday)\n* Availability of a suitable lymphocyte donor (see \"Donor Selection Criteria\").\n* Adequate organ function meeting the following laboratory criteria:\n* Liver function: ALT and AST ≤10× upper limit of normal (ULN); total bilirubin ≤5× ULN\n* Renal function: BUN and creatinine ≤1.25× ULN\n* No cardiac dysfunction on electrocardiogram or echocardiogram\n* Pulmonary function: oxygen saturation \\>90% without supplemental oxygen\n* The patient or legal guardian has the desire and request to receive treatment, signs the informed consent form before treatment, and is willing to comply with the treatment plan, follow-up schedule, and laboratory tests.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from this study:\n\n* Active grade II-IV acute graft-versus-host disease (aGVHD)\n* Active aGVHD requiring prednisone or equivalent corticosteroid \\>0.5 mg\u002Fkg\u002Fday\n* Active viral infection\n* Uncontrolled or relapsed malignancy\n* Other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or affect informed consent, study participation, follow-up, or interpretation of results.","14 Years","50 Years",{"count":176,"type":21},30,[24],"The goal of this clinical trial is to learn whether giving patients a special type of donor immune cells (called CD45RA Depleted DLI) can help prevent viral infections after a stem cell transplant. It will also learn about the safety of this treatment. The main questions it aims to answer are:\n\nDoes this treatment lower the chance of getting serious viral infections after transplant? What medical problems do patients have when receiving this treatment?",[180,181],"Hematologic Malignancy","Haplo-identical HCT",[183,184],"CD45RA","DLI","2026-06-22",{"date":187,"type":35},"2026-06-29",{"date":37,"type":21},{"date":190,"type":21},"2028-07-31",{"name":41,"class":42},{"id":193,"slug":4,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":66},"100643965","NCT07669558","Electrical Impedance Tomography-Guided Identification of the Optimal Lateral Position in Postoperative ARDS","Effect of Left Lateral, Right Lateral, and Supine Positioning on Ventilation-Perfusion Matching Assessed by Electrical Impedance Tomography in Adult Postoperative Abdominal Surgery Patients With ARDS: A Prospective Randomized Crossover Physiological Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Postoperative abdominal surgery patients admitted to the ICU with ARDS (Berlin definition)\n* Considered able to tolerate protocolized position changes by the treating team\n* EIT belt placement and protocol procedures feasible\n* Informed consent obtained from the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Contraindication to lateral positioning (e.g., unstable spine, uncontrolled bleeding, open abdomen, high-risk surgical wound condition)\n* Severe hemodynamic instability or other conditions making participation unsafe\n* High risk of airway\u002Fvascular line\u002Fdrain dislodgement not manageable\n* Pregnancy\n* Refusal of informed consent\n* Any other condition deemed inappropriate by investigators",{"count":199,"type":21},24,[98],"This prospective, randomized crossover physiological study evaluates the effects of lateral positioning (left lateral position and right lateral position) versus the supine position on ventilation-perfusion (V\u002FQ) matching in adult postoperative abdominal surgery participants with acute respiratory distress syndrome (ARDS). Bedside electrical impedance tomography (EIT) will be used to quantify regional ventilation and perfusion (perfusion derived from an intravenous tracer bolus administered during a brief breath-hold) and to calculate global \"normal V\u002FQ\" (normal V\u002FQ, %). Oxygenation, respiratory mechanics (when applicable), and hemodynamics will be recorded concurrently. Feasibility and safety of the positioning protocol will also be assessed.",[203,204],"Acute Respiratory Distress Syndrome (ARDS)","Postoperative",[206,207,208,209,210,211,212],"acute respiratory distress syndrome (ARDS)","electrical impedance tomography (EIT","Lateral position","ventilation-perfusion","postoperative abdominal surgery","crossover study","supine position",{"date":133,"type":35},{"date":215,"type":21},"2026-06-16",{"date":217,"type":21},"2026-10-31",{"name":41,"class":42},{"id":220,"slug":4,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":66},"100644312","NCT07662369","CD45RA-depleted DLI for the Treatment of Refractory\u002FPersistent Viral Infections After Haploidentical Transplantation","Ex Vivo CD45RA-depleted DLI for the Treatment of Refractory\u002FPersistent Viral Infections After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study","CD45RADLITx","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Patients who have undergone hematopoietic stem cell transplantation.\n* Presence of viremia and\u002For viral infection-related disease caused by a single virus or multiple viruses among the following: CMV, EBV, ADV, BK, B19, JC, HHV-6B, HSV1, or HSV2.\n* Patients who, after ≥2 weeks of first-line therapy, have persistent viral positivity, no relief or worsening of clinical symptoms, or re-infection with the same pathogen after viral clearance.\n* Availability of a suitable lymphocyte donor.\n* Adequate organ function, meeting the following laboratory criteria:\n* Liver function: ALT and AST ≤ 10 × upper limit of normal (ULN), TBIL ≤ 5 × ULN.\n* Renal function: BUN and Cr ≤ 1.25 × ULN.\n* No cardiac insufficiency on electrocardiogram (ECG) or echocardiogram.\n* Pulmonary function: oxygen saturation \\> 90% on room air.\n* Willingness and ability of the patient or their legal guardian to receive treatment, comply with the treatment plan, follow-up schedule, and laboratory examinations, and provision of signed informed consent before any study-specific procedure.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from this study:\n\n* Active grade II-IV acute graft-versus-host disease (aGVHD).\n* Prednisone or equivalent corticosteroid dose \\> 0.5 mg\u002Fkg\u002Fday.\n* Receipt of anti-thymocyte globulin (ATG), alemtuzumab (Campath), or other T-cell immunosuppressive monoclonal antibodies within 28 days before enrollment.\n* Less than 28 days after allogeneic transplantation, or receipt of donor lymphocyte infusion (DLI) or virus-specific T cell (VST) therapy within 28 days before enrollment.\n* Uncontrolled or relapsed malignancy.\n* Presence of other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or that may interfere with informed consent, study participation, follow-up, or interpretation of study results.",{"count":176,"type":21},[24,25],"The goal of this clinical trial is to learn whether giving patients special donor immune cells (called \"CD45RA Depleted DLI\") can help treat viral infections that have not improved with standard antiviral drugs. These infections occur after a stem cell transplant. The study will also look at the safety of this treatment.",[180,181],[183,184],{"date":159,"type":35},{"date":233,"type":21},"2026-06-01",{"date":235,"type":21},"2028-06-30",{"name":41,"class":42},{"id":238,"slug":4,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":251,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":66},"100644601","NCT07671261","SEEG-Guided DBS for Schizophrenia","Deep Brain Stimulation for Treatment-Refractory Schizophrenia: Individualized Target Selection and Efficacy","Inclusion Criteria:\n\n* Meets the International Classification of Diseases, 10th Revision (ICD-10) diagnostic criteria for schizophrenia.\n* Male or female, aged 18 to 55 years, with stable vital signs.\n* Currently presents with prominent psychotic symptoms, assessed as moderate or severe by the Positive and Negative Syndrome Scale (PANSS) or other equivalent scales.\n* Exhibits impaired social functioning, assessed as moderate or severe impairment by the Social and Occupational Functioning Assessment Scale (SOFAS) or other equivalent scales.\n* Has a history of sequential treatment with at least two antipsychotic medications of different chemical structures known for strong efficacy against positive symptoms. Treatment must have been at an adequate dose and for an adequate duration (continuous treatment at a therapeutic dose for more than 6 weeks per medication), with good treatment adherence.\n* Has been on a stable antipsychotic medication regimen for at least one month prior to enrollment.\n* Capable and willing to provide written informed consent.\n* Demonstrates good compliance and is able to cooperate with all follow-up procedures.\n\nExclusion Criteria:\n\n* Diagnosed with any psychiatric disorder other than schizophrenia.\n* Presence of a severe personality disorder.\n* History of severe neurological diseases, such as seizures or hemorrhagic stroke.\n* Presence of structural brain abnormalities.\n* Previous history of stereotactic neurosurgery.\n* Contraindications to general anesthesia or stereotactic neurosurgery.\n* Any current or anticipated condition-including medical, psychological, social, familial support, or geographical factors-that might compromise patient safety or interfere with successful participation in the study.","55 Years",{"count":245,"type":21},46,[98],"This is a prospective, randomized, interventional study designed to evaluate the efficacy and safety of SEEG-guided deep brain stimulation (DBS) for symptom improvement in patients with treatment-resistant schizophrenia. Using stereo-electroencephalography (SEEG) to record brain activity, we will identify specific abnormal electrophysiological targets and signal features associated with clinical symptoms, followed by a 12-month open-label stimulation period. The study is conducted in three stages: Stage 1 consists of SEEG brain mapping, screening of intervention targets, and optimization of stimulation parameters; Stage 2 consists of DBS implantation surgery and further optimization of stimulation parameters; Stage 3 is a randomized crossover treatment phase, followed by an open-label treatment period.",[249,250],"Schizophrenia Disorders","Schizo Affective Disorder",[252,253,254,255],"Schizophrenia","Stereoelectroencephalography","Neuroimaging","deep brain stimulation",{"date":257,"type":35},"2026-06-26",{"date":259,"type":35},"2025-08-17",{"date":261,"type":21},"2028-12-31",{"name":41,"class":42},{"id":264,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":26,"conditions":267,"keywords":268,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":272,"leadSponsor":273,"locationsCount":4},"100641403",{"count":20,"type":21},[24,25],[28],[28,30],{"date":270,"type":35},"2026-06-18",{"date":37,"type":21},{"date":39,"type":21},{"name":41,"class":42},{"id":275,"slug":4,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":283,"phases":4,"briefSummary":284,"conditions":285,"keywords":288,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":4},"100641513","NCT07657572","A Multi-center, Prospective, Registry Study to Analyze the Clinical Characteristics and Prognosis of Different Molecular Subtypes of Peripheral T-cell Lymphoma.","Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (EXCELLENT Study)","EXCELLENT","Inclusion Criteria:\n\n* Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2026 to December 2029 and detected by gene sequencing (NGS) with different molecular subtypes.\n* Patients diagnosed with PTCL by histopathology from January 2026 to June 2026 and NGS detection can be performed if there is tumor tissue.\n* Fully understand the study, voluntarily sign the written informed consent form (ICF), and agree to cooperate with genetic testing, treatment, efficacy assessment and long-term follow-up.\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Female patients who are pregnant, breastfeeding, or of childbearing potential without effective contraception;\n* Subjects with poorly controlled neurological, psychiatric, mental or cognitive disorders that may impair their understanding and signing of the informed consent form as well as adherence to the study procedures;\n* Any other conditions deemed inappropriate for enrollment by the investigator.",{"count":282,"type":21},1000,"OBSERVATIONAL","A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.",[286,287],"PTCL","T Cell Lymphoma",[289,290],"Peripheral T Cell Lymphoma","molecular subtypes","2026-06-14",{"date":270,"type":35},{"date":294,"type":21},"2026-06",{"date":296,"type":21},"2030-12",{"name":41,"class":42},{"id":299,"slug":4,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":66},"100642460","NCT07649928","A Study of Dose Escalation of ES502 in Patients With Advanced Pancreatic Cancer","A Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of ES502 Injection in Patients With Advanced Pancreatic Cancer","Inclusion Criteria:\n\n\\-\n\nTo be enrolled in this study, participants must meet all of the following inclusion criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Available fresh or archived tumor tissue samples (within the past 5 years) for testing at screening;\n3. Individuals with histologically or cytologically confirmed advanced solid tumors for whom no standard therapy exists, who are refractory to standard therapy, or who are deemed unsuitable for standard therapy by the investigator. Tumor types include but are not limited to: pancreatic cancer, colorectal cancer, non-small cell lung cancer, intrahepatic cholangiocarcinoma, gallbladder cancer, ovarian cancer, endometrial cancer, and intestinal cancer;\n4. RAS G12V mutation (KRAS\u002FNRAS\u002FHRAS) and positivity for HLA-DPB1\\*03:01, \\*14:01, \\*25:01, or \\*104:01;\n5. Individuals with at least one measurable lesion (defined per RECIST v1.1 as a lesion with the longest diameter ≥10 mm, or a lymph node with a short axis of ≥15 mm); lesions that have undergone radiotherapy or other local therapies are not considered target lesions unless they demonstrate clear progression;\n6. ECOG score: 0-1;\n7. Expected survival greater than 3 months;\n8. Adequate hematological and organ function, as evidenced by the following laboratory tests (the individual must not have received a blood transfusion, long-acting EPO or long-acting G-CSF within 14 days before study treatment, or not have received short-acting EPO or short-acting G-CSF within 7 days before study treatment): 1) hematology: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count (PLT) ≥100 × 10⁹\u002FL, hemoglobin (Hb) ≥90 g\u002FL; 2) liver function test: both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5 × ULN. Exceptions: liver metastasis, AST and\u002For ALT ≤5 × ULN; Gilbert's syndrome, TBIL ≤3 × ULN; pancreatic head cancer or biliary obstruction, TBIL ≤3 × ULN; 3) kidney function test: creatinine clearance (CrCL) ≥50 mL\u002Fmin (by Cockcroft-Gault formula); 4) coagulation function test: activated partial thromboplastin time (APTT) ≤1.5 × ULN and international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN; 5) echocardiography: left ventricular ejection fraction (LVEF) ≥50%; eligibility for enrollment of individuals with out-of-range laboratory results should be determined at the investigator's discretion.\n9. Women of childbearing potential who agree to use at least one medically recognized method for contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment and for 1 year after the last treatment, and have a negative pregnancy test result at screening;\n10. Prior antitumor treatment-related adverse events (AEs) (per NCI-CTCAE v6.0) have resolve to ≤ Grade 1 at screening, except for alopecia, Grade 2 hypothyroidism, and non-clinically significant or asymptomatic laboratory abnormalities;\n11. Individuals who fully understand the informed consent information, agree to participate in this clinical study, and voluntarily sign the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n\\-\n\nTo be enrolled in this study, participants must not meet any of the following exclusion criteria:\n\nTo be enrolled in this study, participants must not meet any of the following exclusion criteria:\n\n1. Individuals with the following tumors:\n\n   * Malignant tumors other than those under investigation in this study (except for cured thyroid cancer, skin basal cell carcinoma, or cervical carcinoma in situ) within the past 5 years;\n   * Meningeal metastases;\n   * Brain metastases, except for individuals who have received systematic and radical therapy (radiotherapy or surgery) for brain metastases, demonstrated radiologically stable disease for at least 4 weeks, discontinued systemic corticosteroids for more than 2 weeks, and remain asymptomatic.\n2. Individuals with the following conditions:\n\n   * Received prior targeted therapy targeting RAS-G12V within 4 weeks before the first dose, or within 5 half-lives of the therapeutic agent, whichever is longer;\n   * Participation in other clinical studies involving an investigational product within 4 weeks before the first dose;\n   * Use of systemic antitumor therapy (including but not limited to chemotherapy, radiotherapy, biotherapy, immunotherapy, and cell therapy) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose;\n   * Receipt of major surgery without complete recovery within 4 weeks before the first dose, or planning to undergo major surgery during the study;\n   * Receipt of systemic immunosuppressants or systemic corticosteroids within 1 week before the first dose;\n   * Receipt of live-attenuated vaccines within 4 weeks before the first dose, or planning to receive such vaccines during the study;\n   * Planning to receive any other systemic antitumor therapy (chemotherapy, radiotherapy, biotherapy, immunotherapy, cell therapy, etc.) during the study;\n3. Symptomatic ascites, pleural effusion or pericardial effusion requiring drainage at screening, or history of drainage for serous effusion within 4 weeks before the first dose;\n4. History of clinically significant cardiovascular disorders at screening, including but not limited to congestive heart failure (NYHA Class ≥ II), unstable angina, myocardial infarction, stroke or transient ischemic attack (TIA), severe arrhythmias (including but not limited to atrial fibrillation or paroxysmal supraventricular tachycardia, complete left bundle branch block or third-degree atrioventricular block with clinical significance and requiring clinical intervention), or poorly controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) within 6 months before enrollment;\n5. QT interval corrected by Fridericia's formula (QTcF) ≥470 ms;\n6. History of severe infection within 4 weeks before the first dose; active infection requiring therapeutic intravenous antibiotics within 2 weeks before the first dose. Use of prophylactic antibiotics is not an exclusion criterion;\n7. Active autoimmune diseases, or any conditions requiring systemic corticosteroids or immunosuppressants (prednisone at ≥20 mg\u002Fday or an equivalent dose) at screening;\n8. History or evidence of clinically unstable or poorly controlled disorders (including but not limited to cardiac, pulmonary, renal, hepatic, metabolic or hematological disorders) at screening;\n9. History of severe allergy or known hypersensitivity to the investigational product or its components;\n10. Organ transplantation, allogeneic stem cell transplantation or renal replacement therapy in the past or at screening;\n11. Pulmonary embolism, pulmonary fibrosis, interstitial lung disease or acute lung disease in the past or at screening;\n12. Positivity for Treponema pallidum antibody, positivity for human immunodeficiency virus (HIV) antibody, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Definition of active HBV infection: positivity for hepatitis B surface antigen (HBsAg), and HBV DNA above the ULN; definition of active HCV infection: positivity for hepatitis C antibody, and HCV RNA above the ULN. Such conditions unsuitable for enrollment as judged by the investigator;\n13. Other circumstances inappropriate for participation in this study as considered by the investigator.",{"count":199,"type":21},[53],"ESSIGHT-HJG-ES502-01 is a dose-escalation study of ES502 in patients with advanced pancreatic cancer. The study will enroll patients with advanced, RAS G12V positive pancreatic cancer who have no effective treatment options available (HLA genotyping required).",[308],"Pancreatic Cancer",[310,311,312],"RASG12V","HLA","T-cell engager","2026-06-10",{"date":215,"type":35},{"date":316,"type":35},"2026-05-18",{"date":318,"type":21},"2029-06",{"name":41,"class":42},{"id":321,"slug":4,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":326,"targetDuration":328,"studyType":283,"phases":4,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":4},"100642567","NCT07641257","Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling","Impact of Icosapent Ethyl on Ventricular Remodeling, Inflammation, and Coronary Plaque Stability in Patients With Acute or Chronic Coronary Syndrome: A Prospective, Observational, Real-World Study","Inclusion Criteria:\n\n* Age 18 years and older, of any sex.\n\n  * Definite diagnosis of chronic coronary syndrome (CCS) according to the Chinese Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndrome, or acute coronary syndrome (ACS) according to the 2025 ACC\u002FAHA\u002FACEP\u002FNAEMSP\u002FSACI Guideline for the Management of Acute Coronary Syndromes.\n  * Laboratory evaluation showing fasting triglycerides (TG) \\>= 1.7 mmol\u002FL.\n  * Ability to fully understand the study purpose, voluntary participation, and provision of signed written informed consent.\n\nExclusion Criteria:\n\n* Women who are planning a pregnancy, currently pregnant, or lactating.\n\n  * Known hypersensitivity or allergic reaction to the active ingredient of icosapent ethyl (IPE) or any of its excipients (applicable to patients in the exposure cohort).\n  * Diagnosed with major life-threatening conditions such as malignant tumors, end-stage lung disease, or advanced neurodegenerative diseases, with a life expectancy of less than 12 months.\n  * Concurrent participation in any other interventional clinical trial involving investigational drugs or medical devices.\n  * Any other condition or severe non-compliance that, in the judgment of the investigator, makes the patient unsuitable for enrollment in this study.",{"count":327,"type":21},420,"12 Months","Even with standard treatments like statins, patients with coronary artery disease often face a residual risk of further heart events. This risk is largely driven by ongoing inflammation and unstable fatty plaques in the heart's blood vessels. Icosapent ethyl (IPE) is a highly purified prescription medication known to improve cardiovascular outcomes, but its detailed effects on the heart's structure and inflammation in everyday clinical practice need further exploration.\n\nThis study is a prospective, observational, real-world study designed to evaluate the effectiveness of IPE in patients with Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS). The study plans to enroll 420 patients who will be followed for 12 months. Based on their routine clinical prescriptions, participants will be grouped into a control group (receiving standard cardiovascular care, including statins) and an exposure group (receiving standard care plus IPE).\n\nThroughout the 1-year follow-up, researchers will conduct regular blood tests and advanced heart imaging. The main goal is to determine if adding IPE to standard therapy leads to a more significant reduction in inflammation. Additionally, the study will observe how IPE affects the stability of coronary plaques and the healing process of ventricular remodeling in a real-world clinical setting.",[331,332,333,334,335,336],"Acute Coronary Syndromes (ACS)","Chronic Coronary Syndrome","Coronary Artery Disease","Atherosclerosis Cardiovascular Disease","Ventricular Remodeling","Inflammation","2026-06-08",{"date":339,"type":35},"2026-06-11",{"date":341,"type":21},"2026-05-30",{"date":343,"type":21},"2029-05-30",{"name":41,"class":42},{"id":346,"slug":4,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":74,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":359,"leadSponsor":361,"locationsCount":66},"100643814","NCT07628738","A Prospective Clinical Study on Reduced-intensity Radiotherapy for Stage I\u002FII Low-risk Nasal-type NK\u002FT-cell Lymphoma Achieving Complete Remission After Chemotherapy","Inclusion Criteria:\n\n* The patient voluntarily agrees to participate in this study and signs the informed consent form.\n* Age ≥ 18 years and ≤ 75 years.\n* Pathologically confirmed diagnosis of nasal-type NK\u002FT-cell lymphoma.\n* Clinical stage I-II disease confirmed by PET-CT or MRI.\n* The lymphoma has been treated with an asparaginase-based chemotherapy regimen.\n* Presence of 0-1 prognostic risk factors (risk factors: age \\> 60 years, ECOG score ≥ 2, elevated LDH, elevated PTI, stage II).\n* Imaging assessment shows complete clinical remission after chemotherapy.\n* ECOG-PS score of 0-1.\n* Expected survival of ≥ 12 months.\n* Normal function of major organs, meeting the following criteria:\n\n  1. Hematology: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 80 × 10⁹\u002FL; hemoglobin ≥ 80 g\u002FL.\n  2. Biochemistry: total bilirubin \\\u003C 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance \\> 50 mL\u002Fmin.\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use highly effective contraception during the study period and for 120 days after the last dose. For male subjects with female partners of childbearing potential, they must be surgically sterile or agree to use highly effective contraception during the study period and for 120 days after the last dose.\n\nExclusion Criteria:\n\n* A previous or concurrent diagnosis of another malignancy, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n* Presence of severe medical conditions, or concomitant diseases or situations that may affect the patient's eligibility for enrollment or compromise safety during the study period.\n* Pregnant or breastfeeding women.\n* Presence of active mental disorders or other psychiatric conditions that may affect the patient's ability to sign the informed consent form or to comprehend the study information.\n* Patients deemed by the investigator to have poor compliance.\n* Distant metastasis confirmed by pathology or imaging.\n* As judged by the investigator, the patient has other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant treatment, significant laboratory abnormalities, or family or social factors that could compromise patient safety.",{"count":351,"type":21},39,[25],"This study is designed to evaluate the efficacy and safety of reduced-intensity radiotherapy for stage I\u002FII low-risk nasal-type NK\u002FT-cell lymphoma that has achieved complete remission after chemotherapy.",[355],"Lymphoma (Non-Hodgkin's Lymphoma)","2026-06-05",{"date":62,"type":35},{"date":37,"type":21},{"date":360,"type":21},"2034-05-01",{"name":41,"class":42},{"id":363,"slug":4,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":174,"maxAge":18,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":384},"100640204","NCT07618481","BCI With 40Hz Stimulation in Alzheimer's Disease","EEG-Based Non-Invasive Brain-Computer Interface Combined With 40Hz Audio-Visual Stimulation for Cognitive Function in Patients With Alzheimer's Disease: A Randomized Double-Blind Controlled Study","Inclusion Criteria:\n\n1. Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.\n2. Age between 50 and 80 years, inclusive.\n3. Positive Aβ-PET scan result.\n4. Has a stable caregiver who can assist with daily stimulation intervention.\n5. Chronic medical conditions stable for at least 30 days.\n6. Adequate vision and hearing to perform testing (at minimum, ability to perceive light and communicate in daily conversation).\n7. Good mobility (able to walk independently or with assistive devices).\n8. Willing and able to provide voluntary signed informed consent.\n\nExclusion Criteria:\n\n1. History of epilepsy or seizure disorder.\n2. Inability to undergo MRI or presence of significant abnormalities on MRI screening.\n3. Geriatric Depression Scale (GDS) score \\> 6.\n4. Current suicidal ideation or suicide attempt within the past 6 months.\n5. Other major neurological disorders, including but not limited to: dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, or mixed dementia; other neurodegenerative diseases (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc.); history of severe brain infection (meningitis\u002Fencephalitis) or multiple concussions; metabolic\u002Fsystemic diseases causing cognitive impairment (syphilis, vitamin B12 or folate deficiency, etc.).\n6. Psychiatric disorders.\n7. Severe cardiac disease, chronic liver\u002Fkidney\u002Frespiratory disease, or uncontrolled diabetes mellitus or thyroid disease.\n8. History of drug or alcohol abuse within the past 12 months.\n9. Current exposure to anti-Aβ antibody immunotherapies.\n10. Current use of memantine within 30 days prior to intervention.\n11. Life expectancy \\\u003C 24 months.",{"count":369,"type":21},90,[98],"This study aims to evaluate the efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. A total of 90 participants with Aβ-PET positive AD diagnosed according to NIA-AA criteria will be enrolled and randomly assigned to three groups in a 1:1:1 ratio: (1) 40Hz stimulation group (fixed 40Hz audio-visual stimulation, 60 minutes daily for 6 months), (2) individualized stimulation group (closed-loop BCI with real-time EEG feedback to adjust stimulation parameters, 60 minutes daily for 6 months), and (3) sham stimulation group (inactive stimulation, same duration). The primary outcome is the change in MoCA-B score from baseline to 6 months. Secondary outcomes include changes in cognitive domain-specific assessments (AVLT, STT, DST), multimodal brain imaging, EEG parameters, peripheral blood AD biomarkers, safety, tolerability, and comparison of efficacy between open-loop and closed-loop stimulation.",[373],"Alzheimer Dementia (AD)",[375,376],"Alzheimer's Disease","Non-Invasive Brain Stimulation","2026-06-02",{"date":379,"type":35},"2026-06-03",{"date":381,"type":35},"2026-05-01",{"date":39,"type":21},{"name":41,"class":42},2,{"id":386,"slug":4,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":66},"100635132","NCT07548710","Study of SA+X in the Treatment of Newly Diagnosed AML","Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Newly diagnosed AML confirmed by bone marrow morphology and immunophenotyping (5th edition WHO diagnostic criteria)\n* Subjects with APL excluded according to fusion gene and chromosome results\n* ECOG performance status 0-3\n* Age ≥ 18 years\n* White blood cell count must be \\\u003C 25 × 10⁹\u002FL at the start of study treatment (can be reduced by leukapheresis and\u002For hydroxyurea)\n* Subjects must have adequate organ function, defined as follows: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), unless elevated due to leukemic organ involvement; serum total bilirubin \\\u003C 3 × ULN; higher levels are acceptable if attributable to ineffective erythropoiesis, leukemic organ involvement, or Gilbert syndrome; serum creatinine \\\u003C 3 × ULN, or estimated creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft-Gault formula\n* Written informed consent obtained from the subject or legal representative\n\nExclusion Criteria:\n\n* FAB classification as M3, or molecularly confirmed APL\n* Refractory \u002F relapsed subjects\n* Subjects with a history of myeloproliferative neoplasms (MPN);\n* Subjects with a history of myelodysplastic syndromes (MDS);\n* Subjects with a history of chronic myeloid leukemia (CML);\n* Subjects with mixed phenotype acute leukemia (MPAL);\n* Documented central nervous system leukemia; or documented extramedullary leukemia (e.g., myeloid sarcoma, skin infiltration), excluding liver, spleen, and lymph node involvement;\n* Hypersensitivity or allergy to any of the study drugs;\n* Physical conditions or organ system dysfunction that impairs the ability to swallow capsules or tablets, or significantly affects gastrointestinal function and\u002For absorption (including malabsorption syndrome, small bowel resection, or uncontrolled inflammatory bowel disease);\n* Cardiac conditions meeting any of the following:a) Long QT syndrome or QTc interval \\> 480 ms;b) Second- or third-degree atrioventricular block; severe, uncontrolled arrhythmia requiring medical treatment;c) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other treatable arrhythmia, clinically significant pericardial disease within 6 months prior to enrollment; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities;\n* Previous or current concurrent malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, in situ breast\u002Fcervical carcinoma, or other malignancies adequately controlled without treatment for more than 6 months;\n* Significantly abnormal liver or renal function (serum bilirubin, AST, ALT, or serum creatinine \\> 3 × upper limit of normal; excluding those deemed by the investigator to be related to AML);\n* Subjects who have received previous anti-AML therapies other than hydroxyurea for cytoreduction, including but not limited to BCL-2, FLT3, IDH1 inhibitors, or other investigational agents;\n* Coagulopathy unrelated to AML;\n* HIV infection, syphilis infection, HCV infection, or active HBV infection (HBsAg positive; or HBsAg negative \u002F HBcAb positive with HBV DNA \\> 1.0 × ULN);\n* Other uncontrolled active infection (as judged by the investigator);\n* Pregnant or breastfeeding women;\n* Unable to understand or comply with the study protocol;\n* Participation in other relevant clinical studies within 30 days (excluding diagnostic studies);\n* Subjects deemed inappropriate for study participation by the investigator.",{"count":392,"type":21},205,[25],"This is a phase II, open-label, multi-center study evaluating the efficacy and safety of sonrotoclax (SA) in combination with azacitidine (AZA) plus individualized targeted or chemotherapeutic agents in adult participants with newly diagnosed acute myeloid leukemia (AML). Eligible participants will be stratified into different treatment arms based on genetic background (FLT3\u002FIDH1 mutation status) and fitness for intensive chemotherapy. All participants will receive sonrotoclax with dose escalation from 20 mg\u002Fday to 320 mg\u002Fday, followed by maintenance dosing, which may be temporarily held by the investigator from Day 14 to Day 28 of each 28-day cycle based on the participant's condition, combined with azacitidine 75 mg\u002Fm²\u002Fday intravenously on Days 1-7. For participants fit for intensive chemotherapy, additional anthracycline (daunorubicin 60 mg\u002Fm²\u002Fday or idarubicin 10 mg\u002Fm²\u002Fday on Days 1-3) will be administered. For participants with FLT3 mutations, gilteritinib 80 mg once daily on Days 1-14 will be added; for those with IDH1 mutations, ivosidenib 500 mg once daily on Days 1-28 will be added.",[396],"Acute Myeloid Leukemia",[398,132,399],"Newly Diagnosed Adult Acute Myeloid Leukemia","Azacitidine",{"date":379,"type":35},{"date":381,"type":35},{"date":403,"type":21},"2028-12-21",{"name":41,"class":42},{"id":406,"slug":4,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":66},"100640480","NCT07613788","Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R\u002FR LBCL","A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed\u002FRefractory Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the written informed consent form.\n* Age 18 years or older.\n* Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression.\n* Relapsed or refractory disease after at least one prior line of systemic therapy.\n* Prior treatment must have included an anthracycline-containing chemotherapy regimen and an anti-CD20 monoclonal antibody.\n* Considered suitable by the investigator to receive glofitamab and CD19 CAR-T cell therapy.\n* Presence of at least one high-risk feature, including extranodal involvement, bulky disease, or TP53 abnormality.\n* ECOG performance status of 0 to 2.\n* Life expectancy of at least 12 weeks.\n* Adequate bone marrow, hepatic, renal, pulmonary, and cardiac function as determined by the investigator.\n* Participants of reproductive potential must agree to use effective contraception during the study period.\n* Able and willing to comply with the study protocol, in the investigator's judgment.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any study treatment or related compounds.\n* Active or uncontrolled infection requiring systemic treatment.\n* History of allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* Uncontrolled or clinically significant viral infection as defined by the protocol.\n* Known central nervous system involvement by lymphoma or clinically significant central nervous system disease that may interfere with study treatment or safety assessment.\n* Severe or uncontrolled cardiovascular disease.\n* Severe autoimmune disease or immune-mediated disease that may interfere with study treatment or safety assessment.\n* Known or suspected history of hemophagocytic lymphohistiocytosis.\n* Recent thromboembolic event before screening.\n* History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ or non-melanoma skin cancer.\n* Receipt of prohibited anticancer therapy, immunosuppressive therapy, live attenuated vaccine, or other prohibited treatment within the protocol-specified period before enrollment.\n* Pregnant or breastfeeding women, or participants planning pregnancy during the study period.\n* Concurrent participation in another interventional clinical trial.\n* Need for prohibited concomitant medications that cannot be discontinued or substituted.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for study treatment or study participation.",{"count":412,"type":21},100,[25],"This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed\u002Frefractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.",[416],"Relapsed\u002FRefractory Large B-cell Lymphoma (LBCL)","2026-05-23",{"date":419,"type":35},"2026-05-29",{"date":421,"type":21},"2026-05",{"date":423,"type":21},"2029-04",{"name":41,"class":42},{"id":426,"slug":4,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":18,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":66},"100603053","NCT07131514","HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","Inclusion Criteria:\n\n1. Age: ≥18 and ≤80 years old, male or female;\n2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;\n3. Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n5. Life expectancy ≥ 12 weeks;\n6. Adequate marrow and organ function;\n7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;\n8. Patients volunteered to participate in this study and signed informed consent;\n\nExclusion Criteria:\n\n1. Previously received any anti-tumor therapy;\n2. the presence of distant metastatic lesions diagnosed by imaging;\n3. Known hypersensitivity to the study drug or any of its components;\n4. previous or concurrent other malignant tumors;\n5. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;\n6. Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;\n7. previous allogeneic hematopoietic stem cell transplantation or organ transplantation;\n8. Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n9. with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);\n10. with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen \\[HBsAg\\] test result at screening together with an HBVDNA test value of ≥10,000 copies\u002Fml \\[2000 IU\u002F ml\\]), active hepatitis C (hepatitis C virus antigen \\[HCV-antibodies\\] at screening), or active hepatitis C (hepatitis C virus antitoxin \\[HCVantibodies\\] at screening).antibody \\[HCV-Ab\\] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;\n11. Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and\u002For lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and\u002For lipase are associated with pancreatic cancer);\n12. Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has completely resolved in childhood and does not require any intervention in adulthood can be included; patients with asthma that requires medical intervention with bronchodilators cannot be Inclusion);\n13. Systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses\n\n    ≤10 mg\u002Fday of prednisone efficacy permitted in the absence of active autoimmune disease\n14. Other situations that the researcher felt should not be included.",{"count":176,"type":21},[25],"To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer",[308],"2026-05-22",{"date":437,"type":35},"2026-05-27",{"date":439,"type":35},"2025-08-25",{"date":441,"type":21},"2027-12",{"name":41,"class":42},{"id":444,"slug":4,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":18,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":66},"100561200","NCT06587061","HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","Inclusion Criteria:\n\n1. Age: ≥18 and ≤80 years old, male or female;\n2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;\n3. Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n5. Life expectancy ≥ 12 weeks;\n6. Adequate marrow and organ function;\n7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;\n8. Patients volunteered to participate in this study and signed informed consent;\n\nExclusion Criteria:\n\n1. Previously received any anti-tumor therapy;\n2. the presence of distant metastatic lesions diagnosed by imaging;\n3. Known hypersensitivity to the study drug or any of its components;\n4. previous or concurrent other malignant tumors;\n5. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;\n6. Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;\n7. previous allogeneic hematopoietic stem cell transplantation or organ transplantation;\n8. Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n9. with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);\n10. with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen \\[HBsAg\\] test result at screening together with an HBVDNA test value of ≥10,000 copies\u002Fml \\[2000 IU\u002Fml\\]), active hepatitis C (hepatitis C virus antigen \\[HCV-antibodies\\] at screening), or active hepatitis C (hepatitis C virus antitoxin \\[HCV-antibodies\\] at screening).antibody \\[HCV-Ab\\] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;\n11. Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and\u002For lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and\u002For lipase are associated with pancreatic cancer);\n12. Other situations that the researcher felt should not be included.",{"count":176,"type":21},[25],"To evaluate the safety and efficacy of HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer",[308],{"date":437,"type":35},{"date":455,"type":35},"2024-12-03",{"date":441,"type":21},{"name":41,"class":42},{"id":459,"slug":4,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":474,"leadSponsor":475,"locationsCount":66},"100637763","NCT07607418","Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS","A Phase II, Multicenter, Open-label Clinical Study of Ivosidenib as Maintenance Therapy in Patients With IDH1-mutated AML and High-risk MDS Who Are Ineligible for Transplantation (IVORY-MAST)","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Molecularly confirmed diagnosis of IDH1-mutated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).\n* Achieved complete remission (CR) or partial remission (PR) after induction therapy.\n* Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n* Signed informed consent.\n* For women of childbearing potential: must have practiced contraception for at least one month prior to screening and commit to using contraception throughout the study period and for the required period after study completion.\n* Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective methods of contraception from the time of signing informed consent until 180 days after the last dose of the study drug.\n\nExclusion Criteria:\n\nParticipants with any of the following criteria will be excluded from the study:\n\n* Prior treatment with an IDH1 inhibitor.\n* Diagnosis of M3 subtype (acute promyelocytic leukemia, APL).\n* Presence of severe hepatic or renal dysfunction.\n* Active infection or other serious comorbidities.\n* Major surgery within 28 days prior to the first dose, or planned surgery during the study period.\n* Diagnosis of any other malignancy within 5 years prior to the first dose, with the exception of early-stage malignancies that have been cured by radical treatment, such as carcinoma in situ of the lung, non-melanoma skin cancer, basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Whether to exclude such patients will be determined by the investigator's assessment.\n* Severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months prior to randomization.\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA≥1000 IU\u002Fml); hepatitis C (positive for anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay); or co-infection with hepatitis B and hepatitis C.\n* Known history of psychoactive substance abuse or drug addiction.\n* Presence of any other serious physical or mental illness, or abnormal laboratory findings that may increase the risk of study participation, interfere with the study results, or make the patient unsuitable for study participation in the opinion of the investigator.\n* Inability to swallow, intestinal obstruction, or other factors affecting drug administration or absorption.\n* Previous concomitant treatment with both drugs of the combination therapy targeting the same pathway as in this study.\n* History of allergy to the study drug or any of its excipients.",{"count":149,"type":21},[25],"This study will explore the efficacy and safety of ivosidenib as maintenance therapy in patients with IDH1-mutated AML and high-risk MDS who are ineligible for transplantation, along with accompanying molecular biomarker research. Patients who meet the eligibility criteria will receive ivosidenib treatment until disease progression or unacceptable toxicity. This study will provide an effective maintenance treatment option for transplant-ineligible patients with IDH1-mutated AML and high-risk MDS.",[468,469],"AML (Acute Myeloid Leukemia)","MDS (Myelodysplastic Syndrome)","2026-05-19",{"date":472,"type":35},"2026-05-26",{"date":435,"type":21},{"date":164,"type":21},{"name":41,"class":42},{"id":477,"slug":4,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":74,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":66},"100641023","NCT07594899","AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL","A Study to Evaluate the Efficacy and Safety of an AI-Driven Treatment Strategy Versus Pola-R-CHP in Patients With Previously Untreated Large B-Cell Lymphoma","GUIDANCE-10","Inclusion Criteria:\n\n* Age 18-75 years with comprehensive geriatric assessment stratified as fit\n* Previously untreated participants with CD20-positive LBCL (without central nervous system involvement)\n* ECOG Performance Status of 0, 1, or 2\n* After 1 cycle of Pola-R-CHP, classified as intermediate-risk or high-risk by AI-based multimodal stratification\n* Life expectancy ≥ 3 months\n* At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)\n* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.\n* Anti-lymphoma drugs have not been used before (except glucocorticoids)\n\nExclusion Criteria:\n\n* Prior solid organ transplantation or SCT\n* Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina\n* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion\n* Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):\n\n  * Absolute neutrophil count \\\u003C1.0 × 10⁹\u002FL.\n  * Platelet count \\\u003C75 × 10⁹\u002FL\n  * Serum AST and ALT ≥ 2.5 x ULN\n  * Total bilirubin ≥ 1.5 x ULN\n  * Serum creatinine clearance \\\u003C 30 mL\u002Fmin (using Cockcroft-Gault formula)\n* Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)：Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)：Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA\n* Participants with a history of progressive multifocal leukoencephalopathy\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of treatment\n* Participants with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases\n* Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study",{"count":484,"type":21},178,[25],"This is a prospective, open-label, multicenter, randomized controlled study in participants with previously untreated large B-cell lymphoma. Participants will be stratified into different risk groups using an AI-based multimodal model. Those classified as intermediate- or high-risk will be randomized in a 1:1 ratio to receive either an AI-guided treatment strategy or Pola-R-CHP. In the experimental arm, participants will receive either genotype-guided targeted agents in combination with Pola-R-CHP or Pola-R-CHP combined with glofitamab, according to their AI-defined risk group and molecular features. Participants in the control arm will receive Pola-R-CHP. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with Pola-R-CHP.",[488],"Large B-Cell Lymphoma (LBCL)","2026-05-17",{"date":470,"type":35},{"date":492,"type":21},"2026-05-06",{"date":494,"type":21},"2029-12-31",{"name":41,"class":42},{"id":497,"slug":4,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":66},"100637965","NCT07602322","LME-Guided Precision Combination Therapy in B-cell Lymphoma Patients After CD19 CAR-T Failure","An Exploratory, Two-Arm Study of LME Subtype-Guided Precision Combination Therapy Strategies in Patients With B-Cell Lymphoma After CD19 CAR-T Therapy Failure","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of gender.\n* Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL, not otherwise specified) or high-grade B-cell lymphoma.\n* Received prior CD19-targeted chimeric antigen receptor (CAR) T-cell therapy.\n* Confirmed stable disease (SD) or progressive disease (PD) at the most recent imaging assessment (according to Lugano 2014 criteria) following CAR-T therapy.\n* Able to provide a formalin-fixed paraffin-embedded (FFPE) tumor tissue sample (fresh biopsy or archival specimen obtained before CAR-T therapy or after recent progression) with sufficient quantity and quality for immunohistochemistry (IHC) testing.\n* Confirmed CD20-positive tumor cells by central laboratory IHC testing.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Adequate organ function (including bone marrow, liver, kidney, and heart).\n* Women of childbearing potential must agree to use highly effective contraception during the study and for a specified period after the last dose of study drug; male patients must agree to use effective contraception during the study and for a specified period after the last dose.\n* Voluntarily agreed to participate in the study, signed the written informed consent form, and willing to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Prior treatment with glofitamab resulting in disease progression.\n* Known severe allergic reactions to any components of the study drugs.\n* Active central nervous system (CNS) lymphoma involvement.\n* Presence of a severe, uncontrolled active infection.\n* Presence of severe cardiovascular or cerebrovascular diseases, uncontrolled diabetes, or uncontrolled hypertension that, in the investigator's judgment, makes the patient unsuitable for study participation.\n* History of or current other malignancies (exceptions: adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).\n* Pregnant or breastfeeding women.\n* Positive for human immunodeficiency virus (HIV) antibody, or active hepatitis B virus (HBV) infection (HBsAg positive with HBV-DNA \\> 1x10\\^3 copies\u002FmL), or active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA positive).\n* Any medical or psychiatric condition that might interfere with study execution or result interpretation, or place the patient at unacceptable risk.\n* Received other anti-tumor therapies (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study enrollment, or have not recovered from toxicities of prior therapies to ≤ Grade 1 or baseline levels (excluding alopecia or other irreversible but non-clinically significant toxicities).",{"count":51,"type":21},[25],"This study evaluates a personalized treatment strategy for patients with large B-cell lymphoma (LBCL) whose disease has relapsed or not responded after CD19 CAR-T cell therapy. Researchers believe that the area surrounding the tumor, called the lymphoma microenvironment (LME), plays a major role in why treatments fail.\n\nIn this study, researchers will classify patients into four different LME subtypes (GC, IN, ME, or DE) using a standard lab test on their tumor samples. Patients will then be randomly assigned to one of two groups. The control group will receive a standard single-drug therapy (glofitamab). The experimental group will receive a tailored combination therapy based specifically on their tumor's LME subtype. The main hypothesis of this study is that customizing the treatment based on the tumor's microenvironment will significantly improve how long patients live without their disease getting worse (progression-free survival) compared to the standard single-drug approach.",[127],[488,507,508],"CAR-T Failure","Lymphoma Microenvironment (LME)","2026-05-15",{"date":435,"type":35},{"date":512,"type":21},"2026-05-14",{"date":514,"type":21},"2028-11-01",{"name":41,"class":42},{"id":517,"slug":4,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":16,"minAge":523,"maxAge":49,"enrollmentInfo":524,"targetDuration":4,"studyType":283,"phases":4,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":4},"100639506","NCT07589361","Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors","Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation (VBS-CSI) With Proton Therapy in Pediatric Tumors: A Single-Center Prospective Observational Cohort Study","VBS-CSI-PT-PED","Inclusion Criteria:\n\n* The patient's legal guardian voluntarily signs the written informed consent form.\n* Age at diagnosis \\> 3 years and ≤ 18 years.\n* Histopathologically confirmed diagnosis of a central nervous system (CNS) tumor.\n* Indication for craniospinal irradiation (CSI) confirmed by multidisciplinary team (MDT) discussion.\n* Karnofsky Performance Score (KPS) ≥ 80.\n* For postoperative patients, complete healing of the surgical incision with no evidence of wound infection or other complications.\n* For women of childbearing potential, effective contraception must be used for at least one month prior to screening, and they must commit to continued contraception throughout the study period and for the required time after study completion.\n\nExclusion Criteria:\n\n* Previous receipt of any form of spinal radiotherapy.\n* Previous major spinal surgery for any reason.\n* Presence of clinically significant and confirmed spinal deformity at enrollment (e.g., Cobb angle \\> 10° measured by MRI or X-ray).\n* Presence of medical contraindications to proton radiotherapy.\n* Presence of any severe, uncontrolled systemic disease (e.g., active infection, severe cardiac, hepatic, renal, or respiratory insufficiency) that, in the investigator's judgment, makes the subject unsuitable for treatment under this protocol.\n* Female patients who are pregnant or breastfeeding.\n* Presence of any severe cognitive or psychiatric disorder that prevents understanding of or cooperation with study assessments.","4 Years",{"count":525,"type":21},38,"his is a single-center, prospective observational study in children and adolescents with central nervous system tumors who need whole-brain and whole-spine radiation therapy (craniospinal irradiation, CSI). The study uses proton therapy with a special vertebral body-sparing (VBS) technique to protect the front and center of the vertebrae, which helps preserve bone marrow function and growth. The main goals are to find safe dose limits for the vertebrae and check how often severe side effects occur. The study will also look at bone marrow preservation, spinal deformity, tumor control, survival, chemotherapy completion, neurocognitive function, quality of life, and growth and development for up to 5 years after treatment.",[528,529,530,531,532],"Pediatric Central Nervous System Tumors","Medulloblastoma","Germinoma","Ependymoma","Atypical Teratoid\u002FRhabdoid Tumor (AT\u002FRT)","2026-05-10",{"date":509,"type":35},{"date":536,"type":21},"2026-04-30",{"date":538,"type":21},"2033-12-31",{"name":41,"class":42},{"id":541,"slug":4,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":4},"100639067","NCT07584850","Evaluation of GI001 for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of GI001 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (r\u002Fr B-NHL)","Inclusion Criteria:\n\n1. Age: 18 years and older (inclusive).\n2. Diagnosis: Diagnosis of CD19-positive relapsed\u002Frefractory B-cell lymphoma\u002Fleukemia:\n\n   * 1\\) CD19-positive relapsed or refractory B-cell lymphoma\u002Fleukemia must meet the following criteria:\n   * Histopathological diagnosis includes: indolent lymphoma (iNHL), including but not limited to follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), etc.; aggressive B-cell lymphoma, including but not limited to diffuse large B-cell lymphoma (DLBCL, including Richter-transformed DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), lymphoblastic lymphoma (LBL), transformed follicular lymphoma (TFL), and T-cell\u002Fhistiocyte-rich large B-cell lymphoma (TCRBCL), etc., and patients in the lymphoma leukemia phase involving the bone marrow.\n   * Definition of refractory: Best response to first-line standard therapy is PD; or response to first-line therapy is SD for 6 months after at least 4 cycles; or no response to second-line or later therapies, including PD as best response to the most recent therapy; or SD for 6 months after at least 2 cycles of the most recent therapy; or disease progression or biopsy-confirmed relapse within 12 months after autologous hematopoietic stem cell transplantation (ASCT); or patients undergoing salvage therapy after ASCT with no remission or relapse (SD or PD) after the last treatment; or relapse more than 3 months after CAR-T cell therapy in CD19+ patients.\n   * Definition of relapse: PD again after achieving remission (including PR or CR) following adequate treatment.\n   * Note: Subjects must have been adequately treated and failed or relapsed after guideline-recommended first-line therapy (including anti-CD20 monoclonal antibody combination therapy or BTK inhibitors).\n   * 2\\) B-cell lymphoma\u002Fleukemia patients with bone marrow relapse must meet the following criteria:\n   * Definition of relapse: Hematological relapse: re-emergence of B-lymphoma cells ( 5%) in peripheral blood or bone marrow in patients who achieved CR, or appearance of extramedullary disease; OR bone marrow or peripheral blood molecular relapse: MRD positivity reappears after HCR and MRD negativity, with an increase of 1 log in MRD levels between two positive samples.\n   * Definition of refractory: Failure to achieve CR after at least two cycles of standard chemotherapy; or failure to achieve CR after at least one cycle of treatment following late relapse ( 12 months) after CR; or relapse after HSCT; or patients undergoing salvage therapy after HSCT failing to achieve remission after the last treatment; or Philadelphia chromosome-positive patients who failed to achieve CR or relapsed after at least two types of TKI treatment, or are intolerant\u002Fcontraindicated to TKI treatment.\n   * 3\\) Patients unsuitable for stem cell transplantation, or with documented refusal of other existing treatments, or for whom no standard treatment plan exists, may also be included.\n3. CD19 expression: CD19 positivity detected by IHC or FACS in tumor specimens, bone marrow, or peripheral blood during screening.\n4. Measurable disease: B-cell lymphoma subjects must have measurable lesions per Lugano 2014 (LDi \\> 1.5 cm for nodal, LDi \\> 1.0 cm for extranodal); B-lymphoma\u002Fleukemia subjects must have B-lymphoma cell proportion 5% at screening.\n5. ECOG performance status: 0-2.\n6. Life expectancy: 12 weeks.\n7. Organ function: Adequate organ function meeting the following laboratory results before enrollment:\n\n   * Blood routine: For B-cell lymphoma patients, bone marrow reserve must meet: ANC \\> 0.5 10E9\u002FL (no short-acting G-CSF within 7 days or long-acting G-CSF within 14 days); ALC 0.5 10E9\u002FL; Platelets 30 10E9\u002FL (no transfusion within 7 days); Hemoglobin 80 g\u002FL (no RBC transfusion within 7 days; EPO allowed). All patients (B-cell lymphoma\u002Fleukemia) require absolute CD3+ T-cell count 150\u002FL.\n   * Liver function: ALT and AST 3 ULN; Total bilirubin 2 ULN.\n   * Renal function: CrCl 60 ml\u002Fmin (Cockcroft-Gault).\n   * Coagulation: Fibrinogen 1.0 g\u002FL; APTT 1.5 ULN; PT 1.5 ULN.\n   * Heart: LVEF 55%.\n   * Oxygen saturation: \\> 91%.\n8. Steroids: Therapeutic doses of steroids must be stopped 72 hours before GI001 infusion (except physiological replacement doses).\n9. CNS prophylaxis: Must be stopped 1 week before GI001 infusion (e.g., intrathecal methotrexate).\n10. Contraception: Subjects and spouses agree to use effective contraception from signing ICF until one year after GI001 infusion or until CAR-T cells are not detected in two consecutive PCR tests (whichever is longer).\n11. Informed Consent: Voluntarily sign the EC-approved ICF before screening.\n\nExclusion Criteria:\n\n1. Prior antitumor therapy (except drugs proven to enhance or not affect CAR-T efficacy after elution):\n\n   * Cytotoxic chemotherapy within 2 weeks before administration.\n   * Small molecule targeted therapy within 2 weeks before administration.\n   * Antibody therapy within 3 weeks before administration.\n   * PEG-asparaginase within 4 weeks before administration.\n   * Immunosuppressive therapy within 4 weeks before administration or requirement for long-term use.\n   * Radiotherapy within 4 weeks before administration.\n   * Bendamustine within 6 months before administration.\n   * Previous gene therapy products, including CAR-T therapy (except patients with no CAR-T in vivo, normal T-cell count\u002Ffunction, and CD19+ tumor).\n   * Previous anti-CD19\u002Fanti-CD3 or any other anti-CD19 therapy (except patients with normal T-cell count\u002Ffunction and CD19+ tumor).\n   * Other interventional clinical trial drugs or antitumor therapies within 4 weeks or 5 half-lives before administration (whichever is shorter).\n2. Other malignancies: Malignancies within 2 years before screening, excluding adequately treated cervical carcinoma in situ, skin cancers, or radically treated localized prostate, breast (DCIS), or papillary thyroid cancers.\n3. Organ transplant: History of solid organ transplantation.\n4. Immunomodulators: Use within 2 weeks before administration or potential use during the study (e.g., thalidomide, lenalidomide, pomalidomide).\n5. Corticosteroids: Requirement for long-term therapeutic doses (Prednisone \\> 15 mg\u002Fday or equivalent), except physiological replacement or topical\u002Finhaled use.\n6. CNS involvement: History or presence of CNS infiltration (leukemia\u002Flymphoma cells in CSF; imaging showing masses\u002Fenhancement; or neurological symptoms with abnormal CSF).\n7. Hypertension: Uncontrolled hypertension despite drug therapy.\n8. Cardiac disease: Severe cardiac disease: MI or CABG\u002Fstenting within 6 months; unstable angina; NYHA Class III heart failure; severe arrhythmia; severe non-ischemic cardiomyopathy.\n9. Systemic disease: Unstable systemic disease: severe liver, kidney, or metabolic disease requiring medication.\n10. Infection: Uncontrolled active infection (bacterial, fungal, viral) requiring IV anti-infectives (continuous signs\u002Fsymptoms without improvement).\n11. Neurological\u002FPsychiatric: Stroke or epilepsy within 6 months; other CNS diseases; uncontrolled psychiatric disorders; history deemed to increase risk or interfere with results.\n12. Thrombosis: History of DVT or PE within 6 months.\n13. Vaccine: Live vaccine within 6 weeks before screening.\n14. Surgery: Major surgery within 2 weeks before screening or planned surgery within 2 weeks after administration (except local anesthesia).\n15. Pregnancy\u002FLactation: Pregnant or nursing women, or those planning pregnancy during\u002Fafter treatment.\n16. Toxicity: Prior non-hematological toxicities not resolved to baseline or Grade 2 (except alopecia, fatigue, peripheral neuropathy).\n17. Viral pseudotyping: Prior treatment using VSV-G or Nipah virus pseudotyping.\n18. Infectious serology: HBsAg+ and\u002For HBcAb+ with HBV-DNA \\> detection limit; HCV antibody+ with HCV-RNA \\> detection limit; HIV antibody+; Syphilis serology+.\n19. Extramedullary relapse: B-cell leukemia patients with isolated extramedullary relapse.\n20. Allergy: Allergy to the study drug, excipients, or Tocilizumab.\n21. Immunodeficiency: Patients with primary immunodeficiency.\n22. HSCT: Planned HSCT within 28 days after GI001 injection.\n23. Other: Other conditions deemed unsuitable by the investigator.",{"count":547,"type":21},9,[53],"The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy in adult patients with relapsed or refractory (r\u002Fr) CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL) or B-cell Leukemia. The main questions it aims to answer are:\n\n* What are the safety and tolerability profiles of GI001, specifically regarding the incidence of Dose-Limiting Toxicities (DLTs) and the determination of the Maximum Tolerated Dose (MTD)?\n* What is the preliminary efficacy of GI001, measured by Objective Response Rate (ORR), Complete Response Rate (CRR), and Duration of Response (DOR)?\n* What are the pharmacokinetic (expansion and persistence of CAR-T cells) and pharmacodynamic (cytokine changes) characteristics of GI001?\n\nParticipants will:\n\n* Undergo a screening process (D-30 to D-3) and baseline evaluation to ensure eligibility, including confirmation of CD19-positive disease.\n* Receive a single intravenous infusion of GI001 at one of four designated dose levels (1E8, 3E8, 7E8 or 1E9 TU) following an \"Accelerated Titration\" and \"3+3\" dose-escalation design.\n* Remain hospitalized for at least 14 days post-infusion for intensive safety monitoring, specifically for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).\n* Provide multiple blood, saliva, and urine samples for pharmacokinetic (PK), pharmacodynamic (PD), and exploratory analysis (including immunogenicity and viral shedding).\n* Participate in efficacy and safety follow-ups through Month 24, followed by a long-term safety follow-up for up to 15 years.",[551],"B-Cell Non-Hodgkin Lymphoma","2026-05-07",{"date":554,"type":35},"2026-05-13",{"date":556,"type":21},"2026-04-20",{"date":558,"type":21},"2029-04-20",{"name":41,"class":42},""]