[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The First Affiliated Hospital with Nanjing Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":567},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,232,0,25,[9,44,70,100,124,146,168,185,208,233,251,277,297,318,339,361,383,409,429,446,467,486,505,529,550],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054274","ultrasound-screening-for-early-detection-of-breast-cancer-in-elderly-women-a-mixed-cluster-individual-rct-100054274",false,"NCT07698366","Ultrasound Screening for Early Detection of Breast Cancer in Elderly Women: A Mixed Cluster-Individual RCT","A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening","Inclusion Criteria:\n\n\\- Female Age 65-80 years Resident in participating community ≥6 months Signed informed consent\n\nExclusion Criteria:\n\n* History of breast cancer Breast screening within past 2 years Severe comorbid conditions affecting survival Acute breast infection Cognitive impairment affecting participation",true,"FEMALE","65 Years","80 Years",{"count":22,"type":23},82440,"ESTIMATED","INTERVENTIONAL",[26],"NA","This multicenter study aims to evaluate whether active breast ultrasound screening can improve the early diagnosis rate of breast cancer in women aged 65 to 80 years, compared with routine elderly health management. The study uses a mixed cluster-individual randomized design based on community implementation capacity. A subgroup of pilot communities will simultaneously collect ultrasound AI data for research performance analysis only, without affecting clinical diagnosis.",[29,30],"Breast Neoplasms","Early Detection of Cancer","NOT_YET_RECRUITING","2026-07-08",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":23},"2026-07-10",{"date":39,"type":23},"2029-12-31",{"name":41,"class":42},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100645195","safety-of-breast-conserving-surgery-for-multifocal-or-multicentric-breast-cancer-100645195","NCT07677956","Safety of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer","Safety Evaluation of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Female patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n2. Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS);\n3. Radiologically confirmed unilateral multifocal or multicentric breast cancer;\n4. No systemic distant metastasis detected on preoperative imaging;\n5. Comprehensive clinical evaluation predicts all tumor lesions can be completely resected by breast-conserving surgery (BCS) to obtain negative surgical margins, and patients are suitable for standardized adjuvant whole-breast radiotherapy postoperatively;\n6. Adequate function of vital organs (cardiac, hepatic, renal and hematopoietic systems) to tolerate surgery, subsequent adjuvant radiotherapy and chemotherapy;\n7. Voluntarily agree to participate in the study after fully understanding the study purpose, procedures, potential risks and benefits, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Inflammatory breast cancer;\n2. Extensive tumor burden that prevents complete resection via breast-conserving surgery or attainment of negative surgical margins;\n3. Severe dysfunction or failure of vital organs (heart, liver, kidney, lung) making patients unable to tolerate surgery, radiotherapy or chemotherapy;\n4. Pregnant or lactating women who are ineligible for postoperative radiotherapy;\n5. Patients who are unwilling or unable to complete long-term postoperative follow-up and data collection.","18 Years",{"count":53,"type":23},100,"OBSERVATIONAL","The objective of this observational study is to evaluate the oncological safety of breast-conserving surgery combined with standard postoperative radiotherapy in adult female patients diagnosed with multifocal or multicentric breast cancer. The main questions it aims to answer are:\n\nWhat is the local recurrence rate and the time distribution of local recurrence after breast-conserving therapy in patients with multifocal or multicentric breast cancer? What independent risk factors are associated with postoperative local recurrence among these patients? There is no separate comparison group in this single-arm prospective cohort study.\n\nParticipants will:\n\nReceive standardized breast-conserving surgery plus routine postoperative radiotherapy and individualized adjuvant therapy in accordance with clinical guidelines; Complete regular clinical follow-up visits, telephone and WeChat follow-ups for at least 3 years after surgery to collect data on surgical complications, tumor recurrence, metastasis and survival status; Fill out standardized questionnaires including Breast-Q, SDS, SAS and EORTC QLQ-C30 to assess postoperative breast satisfaction, psychological status and quality of life.",[57],"Breast Cancer",[59,60,61],"Multifocal or multicentric breast cancer","Breast-conserving surgery","Local recurrence","2026-06-30",{"date":64,"type":35},"2026-07-01",{"date":66,"type":23},"2026-07-15",{"date":68,"type":23},"2036-12-30",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":20,"enrollmentInfo":78,"targetDuration":4,"studyType":24,"phases":80,"briefSummary":82,"conditions":83,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"100622004","phase-4-safety-and-efficacy-of-esketamine---dexmedetomidine-combination-versus-dexmedetomidine-monotherapy-for-hyperactive-delirium-in-icu-patients-on-non-invasive-respiratory-support-seed-nirs-trial-study-protocol-of-a-randomized-controlled-trial-100622004","NCT07377981","Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial","SEED-NIRS","Inclusion Criteria:\n\n1. Age ≥18 years and ≤80 years at the time of randomization;\n2. Hospitalized in the ICU (with an expected ICU stay \\>24 hours);\n3. Patients with hyperactive delirium: meeting criteria for Confusion Assessment Method for the ICU (CAM-ICU)\\[19\\] positivity (i.e., acute onset or fluctuating course plus inattention, and at least one secondary criterion-disorganized thinking or altered level of consciousness) and having agitation which is diagnosed if the Richmond Agitation-Sedation Scale (RASS) score\\[20\\] is superior or equal to +1. (The RASS and CAM-ICU are used to assess sedation and delirium levels. Hyperactive delirium is defined as CAM-ICU positive with RASS \\> +1);\n4. Receiving non-invasive respiratory support (eg. high-flow nasal cannula, CPAP, or non-invasive ventilation) at least for \\>24 hours.\n\nExclusion Criteria:\n\n1. Known or suspected allergy or Contraindications to any of the study drugs;\n2. Severe arrhythmias (e.g., ventricular fibrillation, second- or third-degree atrioventricular block, sick sinus syndrome, ventricular tachycardia, QTc interval ≥470 ms, severe bradycardia (heart rate \\\u003C40 beats per minute), etc.), or left ventricular ejection fraction (LVEF) \\\u003C30%;\n3. Recent administration of esketamine, dexmedetomidine or haloperidol within previous 72 hours.\n4. Pregnancy or lactation;\n5. Conditions that may affect efficacy assessment or cognitive function testing, such as blindness, deafness, aphasic, or coma patients;\n6. History of epilepsy or seizures;\n7. Patients with an estimated survival period of less than 48 hours as judged by the investigator;\n8. Neuropsychiatric conditions per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) that may introduce bias (e.g., active substance use disorder, psychosis, etc.), including alcoholism, drug abuse, or use of psychotropic medications;\n9. Patients receiving non-invasive respiratory support via a tracheostomy;\n10. Patients with untreated or inadequately treated hyperthyroidism;\n11. Severe hepatic insufficiency (Child-Pugh grade C);\n12. Severe renal dysfunction, defined as: chronic renal insufficiency with a glomerular filtration rate (GFR) ≤ 29 mL\u002Fmin\u002F1.73 m²; or subjects on long-term maintenance hemodialysis or peritoneal dialysis;\n13. A history of sleep disorders requiring medical intervention within the past month;\n14. Patients or their legally authorized representatives (family members) who are unable to cooperate or unwilling to provide written informed consent;\n15. Other conditions deemed unsuitable for inclusion by the investigators.","ALL",{"count":79,"type":23},388,[81],"PHASE4","This investigator-initiated, randomized, controlled, single-blind, superiority trial aims to assess the efficacy and safety of esketamine combined with dexmedetomidine for the management of agitation or delirium in intensive care unit (ICU) patients receiving non-invasive respiratory support. The primary endpoint is a clinically prioritized hierarchical composite endpoint within 28 days, including intubation or tracheostomy, delirium duration, and agitation duration.",[84,85,86,87,88,89,90],"Dexmedetomidine","Ketamine","Analgesia","Respiratory Therapy","Intensive Care Units (ICUs)","Agitation","Sedation and Analgesia",[92,86,89,84,85,88,87],"Sedation and analgesia",{"date":94,"type":35},"2026-07-02",{"date":96,"type":23},"2026-08-01",{"date":98,"type":23},"2029-01-01",{"name":41,"class":42},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":17,"sex":77,"minAge":108,"maxAge":20,"enrollmentInfo":109,"targetDuration":4,"studyType":24,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":123,"locationsCount":4},"100645224","the-efficacy-and-safety-of-transcutaneous-auricular-vagus-nerve-stimulation-for-depression-in-pd-100645224","NCT07679529","The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Depression in PD","Transcutaneous Auricular Vagus Nerve Stimulation Alleviates Depressive Symptoms in Patients With Parkinson's Disease and Depression During Verbal Fluency Tasks","PD-D-taVNS","Inclusion Criteria:\n\nThis study recruited right-handed subjects from the Department of Neurology, Huai'an Second People's Hospital. The inclusion criteria for patients with PD and depression were as follows: diagnosis of idiopathic Parkinson's disease based on the clinical diagnostic criteria of the Movement Disorder Society; diagnosis of depressive disorder in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Hamilton Depression Rating Scale (HAMD) score ≥ 8; stable medication regimens for Parkinson's disease for at least one month prior to enrollment; aged 40 to 80 years; and voluntary participation with written informed consent. In addition, age- and gender-matched non-depressed PD patients and healthy controls were enrolled to further compare brain functional characteristics among different groups.\n\nExclusion Criteria:\n\npresence of cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score \\\u003C 23; ongoing use of antidepressant medications; presence of contraindications related to transcutaneous auricular vagus nerve stimulation (taVNS); receipt of vagus nerve stimulation (VNS) treatment within the past month; and comorbid severe neurological, renal, cardiovascular or hepatic diseases.","40 Years",{"count":110,"type":23},30,[26],"This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients with depression. The investigators hypothesize that taVNS will improve depression and cortical activity in Parkinson's disease patients with depression.",[114],"Parkinson Disease",[116,117,118],"Parkinson's disease","depression","taVNS","2026-06-25",{"date":64,"type":35},{"date":64,"type":23},{"date":96,"type":23},{"name":41,"class":42},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":24,"phases":133,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":43},"100645204","phase-1-dihydroartemisinin-for-mafld-100645204","NCT07679542","Dihydroartemisinin for MAFLD","A Single-Arm, Proof-of-Concept Study of Dihydroartemisinin in Adults With Metabolic Associated Fatty Liver Disease","Inclusion Criteria:\n\nAged 18-45 years (inclusive), any gender.\n\nMeets the diagnostic criteria for Metabolic Associated Fatty Liver Disease (MAFLD), requiring both of the following:\n\nEvidence of hepatic steatosis (at least one of the following):\n\nImaging: Ultrasound, CT, or MRI-PDFF showing liver fat content ≥5%.\n\nLiver biopsy: Histologically confirmed steatosis ≥5% (within 6 months prior to enrollment).\n\nFibroScan: Controlled Attenuation Parameter (CAP) ≥248 dB\u002Fm.\n\nEvidence of metabolic dysfunction (at least one of the following):\n\nOverweight\u002FObesity: BMI ≥24 kg\u002Fm² or waist circumference ≥90 cm (male) \u002F ≥85 cm (female).\n\nElevated blood pressure\u002FHypertension: Blood pressure ≥130\u002F85 mmHg, or on antihypertensive medication.\n\nPre-diabetes or Type 2 Diabetes: Fasting blood glucose ≥6.1 mmol\u002FL, or 2-hour post-load glucose ≥7.8 mmol\u002FL, or HbA1c ≥5.7%, or history of T2DM, or HOMA-IR ≥2.5.\n\nElevated blood triglycerides: Fasting serum TG ≥1.70 mmol\u002FL, or on lipid-lowering medication.\n\nReduced HDL-cholesterol: Serum HDL ≤1.0 mmol\u002FL (male) \u002F ≤1.3 mmol\u002FL (female), or on lipid-lowering medication.\n\nParticipants on glucose-, blood pressure-, or lipid-lowering medications must have been on a stable dose for at least 3 months prior to screening.\n\nAll participants must have stable body weight (defined as weight loss or gain not exceeding 5% within 3 months prior to screening and from screening to enrollment).\n\nVoluntary participation, willingness to cooperate with follow-up, and signed informed consent.\n\nExclusion Criteria:\n\nLiver function impairment (defined as any one of ALT, AST, GGT, ALP exceeding 2 times the upper limit of normal (ULN) and\u002For bilirubin exceeding 1.5 times ULN).\n\nLong-term use (exceeding 2 weeks) of drugs known to cause hepatic steatosis or fibrosis (e.g., glucocorticoids, valproate, methotrexate, tamoxifen, amiodarone, oral vitamin E) within the past year.\n\nExcessive alcohol consumption: weekly ethanol intake ≥210 g (male) or ≥140 g (female).\n\nPositive for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCV-Ab).\n\nSpecific liver diseases that can cause fatty liver (e.g., autoimmune hepatitis, Wilson's disease) or other specific conditions (e.g., total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome).\n\nHistory of leukopenia or agranulocytosis.\n\nHistory of bariatric surgery within the past 2 years.\n\nPregnant, planning pregnancy, or lactating women.\n\nHistory of malignancy, cardiovascular disease, chronic kidney disease, decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome), or liver transplantation.\n\nUse of any category of antibiotics within 2 weeks prior to enrollment.\n\nConsidered by the clinical investigator to be unsuitable for participation in the study.","45 Years",{"count":110,"type":23},[134,135],"PHASE1","PHASE2","Brief Summary\n\nPurpose:\n\nThis is a proof-of-concept clinical trial to evaluate whether Dihydroartemisinin (DHA), a medication commonly used to treat malaria, can effectively reduce liver fat in adults with Metabolic Associated Fatty Liver Disease (MAFLD). The study will also rigorously assess the safety and tolerability of DHA in this specific patient population.\n\nStudy Design:\n\nThis is a single-center, open-label, single-arm study. All qualified participants will receive the investigational treatment, with each individual serving as their own baseline control to measure pre- and post-treatment changes. To minimize lifestyle-related confounding factors, all participants will receive standardized dietary and physical activity counseling at baseline and will be instructed to strictly maintain their established lifestyle routines throughout the study period.\n\nParticipants:\n\nThe study plans to enroll approximately 30 adult patients (ages 18 to 45 years) formally diagnosed with MAFLD. MAFLD is defined by the presence of excessive hepatic fat accumulation concurrent with specific metabolic dysfunctions, such as overweight\u002Fobesity, hypertension, elevated blood sugar, or dyslipidemia.\n\nIntervention:\n\nParticipants will be administered oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for a continuous duration of 12 weeks. Upon completion of the intervention, participants will enter a 12-week observational follow-up period to monitor the durability of the treatment effects and long-term safety.\n\nMain Things We Will Measure (Outcomes):\n\nPrimary Outcome: Absolute change in liver fat content from baseline to the end of the 12-week treatment, quantitatively assessed by the gold-standard MRI Proton Density Fat Fraction (MRI-PDFF).\n\nSecondary Outcomes: Changes in supplementary non-invasive liver fat assessments (including Ultrasound-derived Fat Fraction \\[UDFF\\] and FibroScan Controlled Attenuation Parameter \\[CAP\\]), as well as changes in body weight, blood pressure, heart rate, and routine laboratory safety panels (e.g., comprehensive liver and kidney function tests).",[138],"MAFLD","RECRUITING",{"date":64,"type":35},{"date":142,"type":35},"2026-03-30",{"date":144,"type":23},"2026-09-01",{"name":41,"class":42},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":77,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":24,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":43},"100644061","phase-2-a-study-on-the-efficacy-and-safety-of-sintilimab-combined-with-ramucirumab-and-paclitaxel-in-the-treatment-of-gastric-cancer-patients-with-short-term-recurrence-after-adjuvant-therapy-100644061","NCT07669740","A Study on the Efficacy and Safety of Sintilimab Combined With Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients With Short-term Recurrence After Adjuvant Therapy","A Study on the Efficacy and Safety of Sintilimab Combined With Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients With Short-Term Recurrence After Adjuvant Therapy","Inclusion Criteria:\n\n* Age ≥18 years at the time of informed consent.\n* Histologically confirmed gastric or gastroesophageal junction (GEJ)adenocarcinoma.\n* HER2-negative disease, as determined by standard testing methods.\n* Prior D2 radical gastrectomy with R0 resection.\n* Disease recurrence during adjuvant chemotherapy or within 6 months after completion of adjuvant chemotherapy.\n* At least one measurable lesion according to RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate organ and bone marrow function.\n* Life expectancy of at least 3 months.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Active malignancy within the past 5 years, except for adequately treated in situ carcinoma or other cancers with a negligible risk of recurrence.\n* Prior participation in another investigational drug study within 4 weeks prior to enrollment.\n* Symptomatic central nervous system (CNS) metastases.\n* Active autoimmune disease requiring systemic treatment.\n* Uncontrolled cardiovascular disease or uncontrolled hypertension.\n* History of thromboembolic events or clinically significant bleeding disorders within 6 months prior to enrollment.\n* Active tuberculosis or interstitial lung disease.\n* Known hypersensitivity to monoclonal antibodies or any excipients of the study drug.","15 Years","75 Years",{"count":110,"type":23},[135],"To explore the efficacy and safety of sintilimab combined with ramucirumab and paclitaxel in the treatment of advanced gastric cancer patients with short-term recurrence after postoperative adjuvant therapy, and to identify efficacy-related biomarkers to guide subsequent individualized treatment.",[159],"Gastric Cancer (Diagnosis)",[161],"gastric cancer","2026-06-22",{"date":119,"type":35},{"date":64,"type":23},{"date":166,"type":23},"2028-12-30",{"name":41,"class":42},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":154,"enrollmentInfo":174,"targetDuration":4,"studyType":24,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":43},"100643984","phase-2-an-open-label-single-arm-multicenter-exploratory-study-of-adebrelimab-combined-with-gemcitabine-and-albumin-bound-paclitaxel-as-first-line-treatment-for-biliary-tract-malignancies-100643984","NCT07668453","An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies","Inclusion Criteria:\n\n* Age 18 to 75 years, male or female. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. No prior local or systemic treatment for biliary tract malignancy. Histologically or cytologically confirmed initially unresectable or inoperable biliary tract cancer; recurrent biliary tract tumor after surgery; or patients who received post-operative adjuvant therapy must have been off treatment for more than 6 months. Adequate organ and hematological function. Life expectancy of ≥ 3 months. Laboratory results within 7 days prior to the first dose meeting the following criteria:Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, Platelets ≥ 75 × 10\\^9\u002FL, Hemoglobin ≥ 90 g\u002FL (without blood transfusion or G-CSF within 2 weeks prior to screening); Serum albumin ≥ 30 g\u002FL, Total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Serum creatinine ≤ 1.5 × ULN or Creatinine clearance \\> 50 mL\u002Fmin; INR ≤ 1.2 or PT exceeding the normal control range by ≤ 2 seconds; Urine protein \\\u003C 2+ (if ≥ 2+, 24-hour urine protein quantification must be \\\u003C 1.0 g). Women of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must not be lactating. Male subjects with female partners of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug, and must not donate sperm during this period.\n\nExclusion Criteria:\n\n* Pathological diagnosis of mixed hepatocellular carcinoma or containing other non-cholangiocarcinoma malignant components. Prior systemic therapy. History of or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer. Active pulmonary tuberculosis infection within 1 year prior to enrollment; or history of active tuberculosis infection over 1 year ago without formal anti-tuberculosis treatment or with tuberculosis still in the active phase. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. Requiring long-term systemic corticosteroid therapy (dose equivalent to \\> 10 mg\u002Fday prednisone) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are allowed. Severe cardiopulmonary or renal dysfunction. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); history of hypertensive crisis or hypertensive encephalopathy. HBV DNA \\> 2000 IU\u002Fml, or active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection). Active infection requiring systemic therapy. Human immunodeficiency virus (HIV 1\u002F2 antibody) positive. History of psychotropic drug abuse, alcoholism, or drug addiction. History of allergy to study drugs. Other factors that, in the judgment of the investigator, may affect the safety of the subject or compliance with the trial",{"count":110,"type":23},[135],"The purpose of this clinical trial is to evaluate the safety and effectiveness of a new combination therapy for patients with biliary tract cancer that cannot be removed by surgery. Participants will receive an immunotherapy drug called adebrelimab combined with two chemotherapy drugs (gemcitabine and albumin-bound paclitaxel) as their first-line treatment. This is an open-label, single-arm study, meaning all enrolled patients will receive this same combination treatment. The main goal of the study is to determine the Objective Response Rate (ORR), which measures the proportion of patients whose tumors shrink in response to the treatment. Researchers will also evaluate how long patients live without the disease getting worse (Progression-Free Survival), overall survival, quality of life, and any side effects experienced. The study plans to enroll 30 participants.",[178],"Biliary Tract Neoplasms",{"date":119,"type":35},{"date":181,"type":35},"2025-10-20",{"date":183,"type":23},"2027-12-31",{"name":41,"class":42},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":154,"enrollmentInfo":192,"targetDuration":4,"studyType":24,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":43},"100644468","phase-2-a-study-of-mrd-guided-zanubrutinib-plus-sonrotoclax-in-treatment-nave-high-risk-cllsll-patients-100644468","NCT07671378","A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL\u002FSLL Patients","A Prospective Study of MRD-Guided, Time-Limited Therapy With Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) Patients","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be enrolled in this study:\n\nAge between 18 and 75 years, inclusive. Diagnosis of CLL\u002FSLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.\n\nMeeting iwCLL 2018 treatment indications and carrying at least one high-risk factor, including CLL-IPI high-risk\u002Fvery high-risk, del(11q), del(17p)\u002FTP53 mutation, unmutated IGHV, or complex karyotype.\n\nMeasurable disease: presence of measurable lymphadenopathy by computed tomography (CT) scan.\n\nECOG performance status of 0 to 2.\n\nAdequate major organ function meeting the following criteria:\n\n1. Hematologic function: without transfusion or hematopoietic growth factor support for at least 7 days prior to enrollment (at least 14 days for pegylated G-CSF such as pegfilgrastim), and meeting the following criteria: absolute neutrophil count (ANC) \\> 0.75 × 10⁹\u002FL, platelet count (PLT) \\> 30 × 10⁹\u002FL, hemoglobin (Hb) \\> 80 g\u002FL.\n2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN).\n3. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (estimated by Cockcroft-Gault formula).\n4. Total bilirubin (TBIL) ≤ 1.5 × ULN (unless due to Gilbert's syndrome or other non-hepatic causes).\n5. Coagulation function: prothrombin time (PT)\u002Finternational normalized ratio (INR) \\\u003C 1.5 × ULN, activated partial thromboplastin time (APTT) \\\u003C 1.5 × ULN (exceptions may be considered on a case-by-case basis if clearly unrelated to coagulopathy or bleeding disorders).\n\nLife expectancy ≥ 6 months. Female subjects of non-childbearing potential (e.g., postmenopausal for ≥ 1 year with amenorrhea, history of hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) are eligible. Female subjects of childbearing potential must have a negative serum pregnancy test at enrollment.\n\nAble to understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded from this study:\n\nAny prior treatment for CLL or SLL (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and\u002For monoclonal antibody therapy).\n\nHistory of other malignancies, unless:\n\n1. The malignancy has been cured with no known active disease for at least 3 years prior to the first dose and is considered by the treating physician to carry a low risk of recurrence.\n2. Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.\n3. Adequately treated carcinoma in situ with no evidence of disease. Known or suspected history of Richter's transformation. Uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia. Subjects with a decline in hemoglobin level or platelet count due to autoimmune destruction within 4 weeks prior to first dose, or requiring \\> 20 mg prednisone daily (or equivalent) to treat or control autoimmune disease.\n\nUse of \\> 20 mg\u002Fday prednisone within 7 days prior to first dose of study drug (unless used for prophylaxis or treatment of allergic reactions, such as to contrast media).\n\nKnown allergic reaction to any of the study drugs. Known hypersensitivity to xanthine oxidase inhibitors and\u002For rasburicase. Subjects with hypersensitivity to xanthine oxidase inhibitors who cannot receive rasburicase will be excluded.\n\nReceipt of a live attenuated vaccine within 4 weeks prior to first dose of study drug.\n\nActive infection requiring systemic therapy that is ongoing or completed within 14 days prior to first dose, or any uncontrolled active systemic infection.\n\nKnown bleeding disorders (e.g., von Willebrand disease or hemophilia). History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n\nKnown history of HIV infection, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subjects who are positive for HBV core antibody, hepatitis B surface antigen (HBsAg), or HCV antibody must have a negative PCR result prior to enrollment. Subjects with a positive PCR result will be excluded.\n\nMajor surgery within 4 weeks prior to first dose. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's judgment, could compromise the subject's safety or pose an undue risk to the study results.\n\nCurrent active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia, New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months.\n\nInability to swallow capsules\u002Ftablets, or presence of malabsorption syndrome, disease significantly affecting gastrointestinal function, history of partial or total gastrectomy or small bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.\n\nConcurrent use of warfarin or other vitamin K antagonists. Requirement for treatment with strong cytochrome P450 (CYP) 3A inhibitors. Current active, clinically significant hepatic impairment meeting Child-Pugh Class B or C criteria.\n\nFemale subjects who are lactating or pregnant. Unwilling or unable to participate in all required study assessments and procedures.\n\nInability to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization for use of protected health information (in accordance with national and local privacy regulations).",{"count":193,"type":23},24,[135],"This study is a prospective, multicenter, open-label, single-arm phase II clinical trial evaluating the efficacy and safety of an MRD-guided, time-limited therapy with zanubrutinib combined with sonrotoclax in previously untreated high-risk CLL\u002FSLL patients.",[197],"CLL (Chronic Lymphocytic Leukemia)",[199,200],"BCL2i","MRD",{"date":202,"type":35},"2026-06-26",{"date":204,"type":35},"2026-06-01",{"date":206,"type":23},"2030-12-31",{"name":41,"class":42},{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":20,"enrollmentInfo":216,"targetDuration":4,"studyType":24,"phases":218,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":230,"leadSponsor":232,"locationsCount":43},"100643898","phase-3-intra-arterial-thrombolysis-for-acute-ischemic-stroke-with-medium-vessel-occlusion-100643898","NCT07668323","Intra-arterial Thrombolysis For Acute Ischemic Stroke With Medium Vessel Occlusion","Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion： A Multicenter Prospective Randomized Controlled Clinical Trial","IAT-MEVO","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Time from symptom onset or last known well to randomization within 24 hours.\n* Clinical diagnosis of acute ischemic stroke confirmed by CTA or MRA as being caused by isolated acute medium vessel occlusion, including distal M2\u002FM3 segments of the middle cerebral artery, A2\u002FA3 segments of the anterior cerebral artery, or P1\u002FP2\u002FP3 segments of the posterior cerebral artery. Isolated occlusion is defined as a single symptomatic vessel occlusion; patients with multiple vessel occlusions or uncertain culprit vessel are excluded.\n* Baseline NIHSS score ≥ 6, or 3-5 with disabling deficits (e.g., motor weakness, aphasia, visual field defects), and NIHSS score ≤ 25 at the time of randomization.\n* For patients presenting beyond 6 hours from symptom onset: perfusion imaging criteria require Tmax \\> 6s volume ≥ 10 cc, and core infarct volume (defined as rCBF \\\u003C 30%) less than 50% of the Tmax \\> 6s volume.\n* Patient or legally authorized representative is able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Clinical Exclusion Criteria:\n* Pre-stroke modified Rankin Scale (mRS) score \\> 2.\n* Presence of contraindications to intravenous thrombolysis.\n* Known allergy to heparin, contrast media, anesthetics, or other definite contraindications to endovascular treatment.\n* Comorbid severe diseases that may affect outcome assessment, including but not limited to malignancy, severe heart failure, or renal failure, with expected life expectancy \\\u003C 6 months.\n* Uncontrolled hypertension refractory to medical therapy (systolic blood pressure \\> 220 mmHg or diastolic blood pressure \\> 120 mmHg).\n* Baseline blood glucose \\\u003C 2.8 mmol\u002FL (50 mg\u002FdL) or \\> 22.2 mmol\u002FL (400 mg\u002FdL).\n* Known bleeding diathesis, including but not limited to: platelet count \\\u003C 100 × 10⁹\u002FL; heparin treatment within 48 hours with APTT ≥ 35 seconds; oral warfarin with INR \\> 3. Note: Patients without a history or suspicion of coagulation disorders do not require laboratory testing for coagulation parameters prior to enrollment.\n* Stroke onset with seizure or seizure occurring during the course of stroke, precluding accurate determination of baseline NIHSS score.\n* Female patients who are pregnant, lactating, or have a positive pregnancy test at hospital admission.\n* Currently participating in another investigational drug or device study that may interfere with the results of this study.\n* Other conditions judged by the investigator to be unsuitable for participation or posing significant risk to the patient.\n* Imaging Exclusion Criteria:\n* Intracranial hemorrhage confirmed by baseline head CT or MRI, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural\u002Fepidural hemorrhage.\n* Presence of midline shift or cerebral herniation, or other ventricular mass effect with midline shift.\n* Anticipated inability to complete endovascular treatment due to vascular tortuosity, severe vessel wall calcification, or other anatomical challenges.\n* Aortic dissection.\n* Multiple vessel occlusions confirmed by CTA or MRA with inability to identify the symptomatic culprit vessel, such as bilateral middle cerebral artery occlusion or concurrent middle cerebral artery and basilar artery occlusion.\n* Suspected or confirmed non-acute occlusion of the symptomatic culprit vessel.",{"count":217,"type":23},306,[219],"PHASE3","Study purpose:\n\nA multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) phase III trial is planned to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischemic stroke caused by medium vessel occlusion (MeVO), compared with best medical management alone.\n\nEligible participants (aged 18-80 years, baseline NIHSS score 6-25 or 3-5 with disabling deficits, confirmed MeVO within 24 hours of symptom onset) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group.\n\nPrimary endpoint: proportion of patients with favorable functional outcome (modified Rankin Scale score 0-2) at 90±7 days post-randomization.\n\nSecondary endpoints:\n\n1. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization;\n2. Early neurological improvement (NIHSS score change from baseline) at 7±1 days or discharge;\n3. Overall distribution of mRS scores at 90±7 days (shift analysis);\n4. Excellent functional outcome (mRS score 0-1) at 90±7 days;\n5. Health-related quality of life (EQ-5D-5L) at 90±7 days;\n6. Functional independence (Barthel Index score 95-100) at 90±7 days;\n7. Symptomatic intracranial hemorrhage (sICH) per Heidelberg criteria within 48 hours;\n8. Early neurological deterioration (NIHSS increase ≥ 4 points or any single item increase ≥ 2 points) within 7 days;\n9. Any intracranial hemorrhage within 48 hours;\n10. Procedure-related complications;\n11. All-cause mortality within 90±7 days.",[222,223],"Medium Vessel Occlusion","Ischemic Stroke, Acute",[225,226,227],"medium vessel occlusion","acute ischemic stroke","intra-arterial thrombolysis",{"date":119,"type":35},{"date":64,"type":23},{"date":231,"type":23},"2029-08-31",{"name":41,"class":42},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":250,"locationsCount":4},"100644042","prospective-cohort-study-of-local-recurrence-after-radical-breast-cancer-resection-100644042","NCT07668362","Prospective Cohort Study of Local Recurrence After Radical Breast Cancer Resection","Clinicopathological Characteristics and Prognosis of Local Recurrence After Radical Mastectomy for Breast Cancer: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Patients with a prior history of breast-conserving surgery or total mastectomy, with postoperative pathological diagnosis of invasive breast carcinoma or ductal carcinoma in situ (DCIS);\n2. Pathologically confirmed isolated local recurrence of breast cancer after primary surgery, without evidence of distant metastasis;\n3. Aged ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and eligible to receive reoperation and subsequent anti-tumor therapy;\n4. Voluntarily participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of concurrent distant metastasis at the time of breast cancer local recurrence;\n2. Severe dysfunction or failure of vital organs (cardiac, hepatic, renal, etc.) that contraindicates reoperation or systemic anti-tumor treatment;\n3. Inability to complete scheduled long-term follow-up as required by the study.",{"count":53,"type":23},"The goal of this observational study is to analyze clinicopathological characteristics and identify independent prognostic risk factors, as well as compare treatment outcomes in female patients aged ≥18 years with pathologically confirmed local recurrence of breast cancer after radical surgery (breast-conserving surgery or total mastectomy) without distant metastasis. The main questions it aims to answer are:\n\nWhat clinical and pathological factors independently affect progression-free survival (PFS) and overall survival (OS) of breast cancer patients with postoperative local recurrence? Do clinical features and long-term prognosis differ between patients with local recurrence after breast-conserving surgery and those after total mastectomy? Can we identify optimal individualized treatment regimens and suitable populations for re-breast-conserving surgery and postoperative radiotherapy after R0 resection?\n\nParticipants will:\n\nProvide complete baseline demographic, initial clinicopathological, primary surgical and adjuvant treatment data, local recurrence lesion characteristics and post-recurrence treatment information via standardized case report forms; Undergo routine clinical examinations, imaging reviews and pathological rechecks as standard clinical practice; Receive standardized follow-up for at least 3 years through outpatient visits supplemented by telephone\u002FWeChat contact to record disease progression, secondary local recurrence, distant metastasis, all-cause death and treatment adverse events.",[57],[244,61,245],"Breast cancer","Prospective cohort study",{"date":119,"type":35},{"date":248,"type":23},"2026-07-20",{"date":68,"type":23},{"name":41,"class":42},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":24,"phases":261,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":43},"100560442","phase-2-neoadjuvant-short-course-radiotherapy-followed-by-capox-plus-pd-1-antibody-and-il-2-in-locally-advanced-rectal-cancer-100560442","NCT06577194","Neoadjuvant Short-Course Radiotherapy Followed by CAPOX Plus PD-1 Antibody and IL-2 in Locally Advanced Rectal Cancer","A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Followed by Sequential Immunotherapy With CAPOX Combined With PD-1 Antibody and IL-2 for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Males and females aged between 18 and 70 years;\n* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;\n* Tumor tissue samples obtained and histologically confirmed as rectal adenocarcinoma;\n* Adequate hematological, liver, and kidney functions: neutrophil count ≥ 1.5×10\\^9\u002FL; platelet count ≥ 75×10\\^9\u002FL; serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL; serum creatinine ≤ 1.5× UNL.\n\nExclusion Criteria:\n\n* Metastatic disease (Stage IV);\n* Recurrent rectal cancer;\n* Concurrent active bleeding, perforation, or other complex situations that cannot be addressed with emergency colostomy surgery alone;\n* Previous systemic anti-cancer treatment for colorectal cancer;\n* Coexistence of other non-colorectal cancer malignancies;\n* Patients with any active autoimmune diseases, or a history of needing steroids or immunosuppressive drugs;\n* Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia);\n* Previous treatment-induced any grade 2 or above toxicity reaction (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 classification) that has not subsided (excluding anemia, hair loss, and skin pigmentation);\n* Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies;\n* Pregnant or breastfeeding women;\n* Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);\n* Known or suspected allergy history to any drugs used in the trial.","70 Years",{"count":260,"type":23},35,[135],"A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer",[264,265],"Rectal Cancer","Advanced Solid Tumor",[267,268,269],"Immunotherapy","Short-course radiotherapy","IL-2",{"date":271,"type":35},"2026-06-24",{"date":273,"type":35},"2024-10-05",{"date":275,"type":23},"2028-10-31",{"name":41,"class":42},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":24,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":43},"100642145","phase-1-single-arm-clinical-study-of-ezh2i-in-combination-with-glofitamab--gemox-in-patients-with-relapsed-refractory-dlbcl-100642145","NCT07643805","Single-Arm Clinical Study of EZH2i in Combination With Glofitamab + GemOx in Patients With Relapsed\u002F Refractory DLBCL","A Prospective, Single-Arm, Phase Ib\u002FII Clinical Study of the EZH2 Inhibitor in Combination With Glofitamab Plus GemOx for the Treatment of Relapsed\u002FRefractory DLBCL","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female;\n2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);\n3. Relapsed\u002Frefractory (R\u002FR) disease；\n4. At least one prior line of therapy containing rituximab;\n5. Subjects must have at least one measurable lesion;\n6. ECOG PS 0-2;\n7. Life expectancy ≥ 3 months;\n8. Adequate organ and bone marrow function, without severe hematopoietic abnormalities or cardiac, pulmonary, hepatic, renal, thyroid dysfunction, or immunodeficiencies;\n9. Female subjects of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study drug; WOCBP subjects and male subjects with WOCBP partners must agree to practice effective contraceptive measures from the time of signing the informed consent form (ICF) until 6 months after the last dose of study drug;\n10. Signed informed consent form (ICF), voluntarily agreeing to participate in this study.\n\nExclusion Criteria:\n\n1. Patient is a candidate for hematopoietic stem cell transplantation.\n2. Prior allogeneic hematopoietic stem cell transplantation.\n3. Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.\n4. History of severe hypersensitivity or anaphylactic reaction to humanized or murine monoclonal antibodies.\n5. Prior treatment with an EZH2 inhibitor, and\u002For an anti-CD20 and CD3 bispecific antibody, and\u002For GemOx (gemcitabine and oxaliplatin).\n6. History of other malignancies within the past 2 years requiring systemic therapy.\n7. Receipt of systemic anti-neoplastic therapy, including chemotherapy, immunotherapy, biologic therapy, etc., within 14 days prior to the start of study treatment.\n8. Major surgery (excluding diagnostic procedures) within 28 days prior to the start of study treatment.\n9. Presence of any active, known, or suspected autoimmune disease. (Subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll.)\n10. Use of immunosuppressive agents, including systemic corticosteroids, within 14 days prior to study drug administration (use of ≤10 mg\u002Fday prednisone or equivalent is permitted).\n11. Any active infection requiring systemic anti-infective therapy within 14 days prior to the start of study treatment.\n12. Presence of any uncontrolled comorbid conditions that may affect compliance with the study protocol, including major cardiovascular disease, bleeding disorders, etc.\n13. Active hepatitis B virus (HBV) infection (HBV DNA positive) or hepatitis C virus (HCV) infection.\n14. Known history of human immunodeficiency virus (HIV) positivity.\n15. Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption.\n16. Known history of hypersensitivity to the study drug.\n17. Pregnant or breastfeeding women.\n18. Any other condition deemed inappropriate for inclusion by the investigator.",{"count":285,"type":23},46,[134,135],"Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed\u002F Refractory DLBCL",[289],"DLBCL","2026-06-09",{"date":292,"type":35},"2026-06-12",{"date":204,"type":23},{"date":295,"type":23},"2030-09-30",{"name":41,"class":42},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":258,"enrollmentInfo":305,"targetDuration":4,"studyType":24,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":43},"100641725","phase-2-different-dose-scrt-plus-capox-pd-1-blockade-and-il-2-in-larc-100641725","NCT07646639","Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC","Different-Dose Short-Course Radiotherapy Plus CAPOX, Anti-PD-1 Antibody and Interleukin-2 for Locally Advanced Rectal Cancer: A Single-Centre, Prospective, Randomised Phase II Trial","PRIDE-02","Inclusion Criteria:\n\n1. Male and female patients aged 18 to 70 years.\n2. Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge.\n3. MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease.\n4. Adequate hematologic, hepatic, and renal function defined as: absolute neutrophil count \\>=1.5 x 10\\^9\u002FL; platelet count \\>=75 x 10\\^9\u002FL; serum total bilirubin \\\u003C=1.5 x upper normal limit (UNL); aspartate aminotransferase \\\u003C=2.5 x UNL; alanine aminotransferase \\\u003C=2.5 x UNL; serum creatinine \\\u003C=1.5 x UNL.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n\nExclusion Criteria:\n\n1. Metastatic disease (Stage IV).\n2. Recurrent rectal cancer.\n3. Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery.\n4. Prior systemic anticancer therapy for rectal cancer.\n5. Presence of another non-colorectal neoplastic disease at the same time.\n6. Patients with any active autoimmune disease or a history of autoimmune disease requiring steroids or immunomodulatory therapy.\n7. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonitis).\n8. Any unresolved grade \\>=2 toxicity (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) resulting from previous treatment, except for anemia, alopecia, and skin hyperpigmentation.\n9. Prior treatment with anti-programmed death-1 (PD-1)\u002FPD-L1 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.\n10. Pregnant or breastfeeding women.\n11. Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).\n12. Known or suspected history of allergy to any of the relevant drugs used in the study.",{"count":306,"type":23},122,[135],"This prospective, randomized phase II trial is designed to evaluate whether low-dose short-course radiotherapy differs from common-dose short-course radiotherapy in terms of efficacy when both regimens are sequentially combined with CAPOX, a PD-1 monoclonal antibody, and interleukin-2 (IL-2) in patients with locally advanced rectal cancer. The study is based on findings from our previous single-center, single-arm PRIDE01 study, in which neoadjuvant short-course radiotherapy followed by systemic chemoimmunotherapy and IL-2 demonstrated encouraging antitumor activity relative to historical short-course radiotherapy-based approaches. The current trial aims to provide more robust clinical evidence regarding the potential role of low-dose radiotherapy combined with IL-2 as a sensitization strategy in multimodal neoadjuvant therapy. By comparing complete response rates between the two radiotherapy dose levels, this study may help define an optimized neoadjuvant approach and support future organ-preservation strategies for patients with locally advanced rectal cancer.",[264,310],"Radiotherapy",[267,269,268],{"date":313,"type":35},"2026-06-15",{"date":315,"type":35},"2026-05-20",{"date":206,"type":23},{"name":41,"class":42},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":24,"phases":327,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":336,"leadSponsor":338,"locationsCount":43},"100643266","early-phase-1-safety-and-efficacy-of-rn9101-in-the-treatment-of-relapsedrefractory-multiple-myeloma-100643266","NCT07628595","Safety and Efficacy of RN9101 in the Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Phase 1 Clinical Study Evaluating the Safety and Efficacy of RN9101 in the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be enrolled in this study:\n\n  1. Age ≥18 years, either sex;\n  2. Diagnosis of multiple myeloma (MM) according to IMWG response criteria, with BCMA target antigen expression on MM cells confirmed by flow cytometry or bone marrow pathology and immunohistochemistry;\n  3. Received at least 2 prior lines of anti-multiple myeloma therapy, with each line containing at least one complete treatment cycle, and documented disease progression during or after the most recent anti-myeloma therapy based on assessment data;\n  4. Measurable disease at screening, defined as meeting at least one of the following criteria:\n\n     1. Serum M-protein ≥ 0.5 g\u002FdL;\n     2. Urine M-protein level ≥ 200 mg\u002F24 h;\n     3. Involved serum free light chain ≥ 10 mg\u002FdL with abnormal serum free light chain κ\u002Fλ ratio;\n     4. Clinical relapse: a. New bone lesions or soft tissue plasmacytomas (excluding osteoporotic fractures); b. Definite increase in existing plasmacytomas or bone lesions (sum of the products of perpendicular diameters \\[SPD\\] of measurable lesions increased by ≥50% with an absolute increase of ≥1 cm);\n  5. ECOG performance status of 0-2, with an estimated life expectancy of ≥3 months;\n  6. Bone marrow function test results (at screening or within 2 months prior to screening) meeting the following conditions:\n\n     1. Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week prior to screening), with recombinant human erythropoietin permitted; for patients meeting the hemoglobin ≥ 6 g\u002FdL enrollment criterion, red blood cell transfusions may be allowed to maintain hemoglobin ≥ 6 g\u002FdL;\n     2. Absolute neutrophil count (ANC) ≥ 600\u002FμL (no granulocyte colony-stimulating factor \\[G-CSF\\] used within 1 week prior to screening, or no pegylated G-CSF used within 2 weeks prior to screening);\n     3. Platelet count ≥ 50,000\u002FμL;\n     4. Lymphocyte count ≥ 500\u002FμL;\n     5. Absolute CD3-positive T-cell count ≥ 150\u002FμL;\n  7. Normal renal function during screening or within 2 months prior to screening: creatinine clearance (CrCl) (calculated by the Cockcroft-Gault formula) ≥ 45 mL\u002Fmin;\n  8. Hepatic function during screening or within 2 months prior to screening meeting the following conditions:\n\n     1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN);\n     2. Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert's syndrome, where direct bilirubin may be ≤ 1.5 × ULN);\n     3. Albumin ≥ 3 g\u002FdL;\n  9. Cardiac function during screening or within 2 months prior to screening meeting the following conditions:\n\n     1. Left ventricular ejection fraction (LVEF) ≥ 40% (assessed by echocardiography or MUGA scan);\n     2. No clinically significant pericardial effusion;\n     3. No clinically significant electrocardiogram abnormalities;\n  10. Pulmonary function during screening or within 2 months prior to screening meeting the following conditions:\n\n      1. Oxygen saturation ≥ 90%;\n      2. No clinically significant pleural effusion;\n  11. For females of childbearing potential, a negative pregnancy test at screening and prior to dosing, and not currently breastfeeding;\n  12. Males and females of childbearing potential must agree to use effective contraception from the date of informed consent signing until 1 year after the end of study treatment;\n  13. Males and females of childbearing potential must agree not to donate gametes (including sperm or ova) from the date of informed consent signing until 1 year after the end of study treatment;\n  14. The subject or their legally authorized representative has signed the Informed Consent Form (ICF), indicating understanding of the study objectives and procedures, and voluntary participation in this study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from the study:\n\n  1. Received other anti-tumor therapy during the screening period (as determined primarily by the investigator):\n\n     1. Received targeted therapy, epigenetic therapy, other investigational drug therapy, or treatment involving invasive investigational medical devices within 5 half-lives;\n     2. Received systemic immunologic or non-immunologic therapy within 1 week;\n     3. Received cytotoxic therapy within 1 week;\n     4. Received proteasome inhibitor and immunomodulatory therapy within 2 weeks;\n     5. Received radiotherapy within 4 weeks (except if the radiation field involves ≤5% of bone marrow reserve, in which case there is no restriction on the time since completion of radiotherapy, and the subject may still be enrolled);\n  2. Received allogeneic hematopoietic stem cell transplantation within 6 months prior to dosing, or autologous hematopoietic stem cell transplantation within 3 months prior to dosing;\n  3. History of malignancy other than multiple myeloma prior to screening, except for the following: malignancies treated with curative intent and with no known active disease for ≥2 years prior to enrollment; adequately treated non-melanoma skin cancer with no current evidence of disease;\n  4. Previously received any therapy utilizing vesicular stomatitis virus glycoprotein (VSV-G) pseudotyped virus;\n  5. Presence of severe and uncontrolled infection during screening (including bacterial, viral, fungal, etc.);\n  6. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range detected within 6 months prior to infusion; positive hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal range; positive human immunodeficiency virus (HIV) antibody; positive syphilis test;\n  7. Symptomatic heart failure or other cardiac diseases, such as severe arrhythmias:\n\n     1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n     2. Myocardial infarction within 6 months prior to informed consent signing, or prior coronary artery bypass grafting (CABG) or coronary artery stent implantation;\n     3. Clinically significant ventricular arrhythmias or history of unexplained syncope (excluding vasovagal or dehydration-induced syncope);\n     4. History of severe non-ischemic cardiomyopathy;\n  8. Other clinically significant diseases, including:\n\n     1. Primary immunodeficiency;\n     2. Stroke or seizure within 6 months prior to screening;\n     3. Definite clinical evidence of dementia or altered mental status;\n     4. Parkinson's disease, parkinsonian movement disorders, or relevant history;\n  9. Received surgery within 2 weeks prior to dosing, or planned surgery within 2 weeks after dosing (except for local anesthesia procedures);\n  10. Received live attenuated vaccines within 1 month prior to dosing;\n  11. Known severe allergic reaction to RN9101 or any of its formulation components;\n  12. Known severe allergic reaction to tocilizumab;\n  13. Patients unsuitable for intravenous infusion;\n  14. Other conditions deemed by the investigator as rendering the subject unsuitable for participation in this study.",{"count":326,"type":23},19,[328],"EARLY_PHASE1","This is a single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of RN9101 injection for patients with relapsed\u002Frefractory multiple myeloma.",[331],"Multiple Myeloma (MM)","2026-06-07",{"date":334,"type":35},"2026-06-10",{"date":64,"type":23},{"date":337,"type":23},"2028-11-01",{"name":41,"class":42},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":24,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":360,"locationsCount":43},"100640247","phase-1-a-study-of-the-lvivo-tavec122-product-in-subjects-with-relapsedrefractory-b-cell-malignancies-100640247","NCT07628582","A Study of the LVIVO-TaVec122 Product in Subjects With Relapsed\u002FRefractory B-cell Malignancies","An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the LVIVO-TaVec122 Product in Subjects With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. Subjects voluntary agreement to provide written informed consent.\n2. Age ≥ 18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. At least one evaluable tumor lesion.\n5. Relapsed and\u002For refractory Non-Hodgkin Lymphoma (NHL) , and relapsed and\u002For refractory Chronic Lymphocytic Leukemia (CLL) with treatment indications.\n6. Clinical laboratory values meet screening visit criteria.\n7. Adequate organ function.\n\nExclusion Criteria:\n\n1. Prior antitumor therapy with insufficient washout period.\n2. Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies.\n3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).\n4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to Human Albumin, or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).\n5. Female subjects who were pregnant, breastfeeding.\n6. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.",{"count":347,"type":23},48,[134],"This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed\u002FRefractory B-cell Malignancies.",[351],"Relapsed\u002FRefractory B-cell Malignancies",[353],"B-cell malignancies","2026-06-04",{"date":356,"type":35},"2026-06-05",{"date":358,"type":23},"2026-09-15",{"date":295,"type":23},{"name":41,"class":42},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":154,"enrollmentInfo":367,"targetDuration":4,"studyType":24,"phases":369,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":382,"locationsCount":43},"100638471","a-prospective-multicenter-phase-ii-clinical-study-of-postoperative-chemotherapy-combined-with-ql1706-for-high-risk-triple-negative-breast-cancer-100638471","NCT07622836","A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.","Inclusion Criteria:\n\n1. The participant voluntarily joins this study and signs the informed consent form.\n2. Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC 2+\u002FISH-) based on the most recent biopsy or other pathological specimen, according to the latest ASCO\u002FCAP guidelines. Patients with low ER or PR expression (1%-10%) may also be included in this study.\n3. Patients with high-risk TNBC (defined as lymph node-positive).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Agree to provide intraoperatively obtained tumor histopathological specimens (FFPE, at least 5 sections) for biomarker testing.\n6. Expected survival ≥3 months.\n7. Function of vital organs meets the following requirements (use of any blood components or cell growth factors within 14 days before the first dose is not allowed):\n\n   * Absolute neutrophil count ≥1.5×10⁹\u002FL;\n   * Platelet count ≥100×10⁹\u002FL;\n   * Hemoglobin ≥90 g\u002FL;\n   * Serum albumin ≥30 g\u002FL;\n   * Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should also be assessed; if FT3 and FT4 are within normal range, the patient may be enrolled);\n   * Serum total bilirubin ≤1.5×ULN;\n   * ALT and AST ≤2.5×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN;\n   * ALP ≤2.5×ULN (in patients with liver or bone metastases, ALP ≤5×ULN);\n   * Serum creatinine ≤1.5×ULN;\n   * International normalized ratio (INR) ≤1.5×ULN (not receiving anticoagulation therapy).\n8. Female participants who are not surgically sterilized or are of childbearing potential must use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Female participants of childbearing potential who are not surgically sterilized must have a negative serum or urine HCG test within 7 days before the first dose and must not be lactating.\n\nExclusion Criteria:\n\n1. Presence of any active autoimmune disease or history of autoimmune disease (e.g., including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism); however, participants with the following conditions are allowed to enroll: vitiligo, psoriasis, alopecia not requiring systemic treatment; well-controlled type I diabetes mellitus; hypothyroidism stable on hormone replacement; childhood asthma that has completely resolved and requires no intervention in adulthood; asthma requiring bronchodilators for medical intervention is excluded.\n2. Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment.\n3. History of severe hypersensitivity reaction to other monoclonal antibodies.\n4. Prior discontinuation of anti-PD-1\u002FPD-L1 antibody therapy due to related toxicity.\n5. Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.\n6. History of CNS metastases or current central nervous system (CNS) metastases. Baseline imaging to rule out brain metastases is not mandatory. Patients with unknown CNS metastasis status but with any clinical signs suggestive of CNS metastases are eligible only if CT and\u002For MRI scans rule out CNS metastases.\n7. Previous history of other malignancies (except for patients with non-melanoma skin cancer or carcinoma in situ of the cervix, who are eligible; patients with other prior malignancies must have been disease-free for at least 3 years).\n8. Hypertension poorly controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); achieving the above parameters with antihypertensive treatment is allowed. History of hypertensive crisis or hypertensive encephalopathy.\n9. Within 6 months before first dose, known history of unstable angina, myocardial infarction (MI), or chronic heart failure (CHF), or known history of clinically significant arrhythmia requiring antiarrhythmic therapy (except stable atrial fibrillation), or left ventricular ejection fraction \\\u003C50%.\n10. Current thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low-molecular-weight heparin is permitted.\n11. Presence of pleural effusion, ascites, or pericardial effusion requiring drainage; patients may be enrolled if clinically stable after drainage as assessed by the investigator.\n12. Arterial\u002Fvenous thrombotic events occurring within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n13. Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before start of study treatment.\n14. Major surgery (excluding diagnostic procedures) within 4 weeks before start of study treatment, or anticipated need for major surgery during the study.\n15. Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein \\>1.0 g.\n16. Prior radiotherapy (except palliative radiotherapy for bone lesions), chemotherapy, or surgery (except biopsy) with completion (last dose) less than 4 weeks before the first study dose; last dose of antibody therapy less than 4 weeks before first study dose; molecular targeted therapy (including oral targeted drugs from other clinical trials) less than 5 half-lives before first study dose, or adverse reactions from prior treatment (excluding alopecia) not recovered to ≤CTCAE grade 1.\n17. Active infection, unexplained fever ≥38.5°C within 7 days before dosing, or baseline white blood cell count \\>15×10⁹\u002FL.\n18. Congenital or acquired immunodeficiency (e.g., HIV infection); hepatitis B surface antigen (HBsAg) positive with HBV DNA ≥2000 IU\u002FmL; or hepatitis C virus antibody positive.\n19. Prior treatment with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or anti-CTLA-4.\n20. Receipt of live vaccine within 4 weeks before first study dose or possible vaccination during the study period.\n21. As judged by the investigator, any other condition that may affect the study results or cause forced premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including psychiatric illness) requiring concomitant treatment, severe laboratory abnormalities, or family\u002Fsocial factors that may affect patient safety.\n22. Women who are pregnant or breastfeeding.",{"count":368,"type":23},59,[26],"This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer.\n\nAfter enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.\n\nAfter completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends.\n\nAfter enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.",[372,373,374],"TNBC","Adjuvant Therapy","Lymph Node Positive",[372,376],"QL1706","2026-06-02",{"date":379,"type":35},"2026-06-03",{"date":356,"type":23},{"date":206,"type":23},{"name":41,"class":42},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":390,"maxAge":108,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":399,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100596827","a-multicenter-prospective-randomized-controlled-clinical-trial-comparing-constant-5-versus-sequential-5-2-oxygen-concentration-embryo-culture-protocols-in-assisted-reproductive-technology-100596827","NCT07050537","A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology","A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology: Evaluating Term Live Birth and Offspring Health Outcomes","Inclusion Criteria:\n\n1. Female: age ≥20 and ≤40 years, male: age ≥20 and ≤50 years;\n2. Proposed 1st or 2nd cycle of IVF or ICSI fertilization;\n3. ≥ 4 transferable embryos at oocyte stage.\n\nExclusion Criteria:\n\n1. Diagnosis of abnormal uterine cavity morphology (confirmed by 3D ultrasound or hysteroscopy), including uterine malformations (mediastinal uterus, unicornuate uterus, bicornuate uterus), submucosal uterine fibroids, or uterine adhesions;\n2. Patients who are proposed to undergo IVM;\n3. Patients who are proposed to undergo PGD\u002F PGS;\n4. Patients with untreated severe hydrosalpinx (confirmed by ultrasound or HSG);\n5. Patients with a history of recurrent miscarriage (2 or more previous pregnancy losses, excluding biochemical pregnancies);\n6. Patients who plan to freeze whole embryos and are unable to complete a single embryo transfer within six months;\n7. Patients with contraindications to assisted reproductive technology and pregnancy, or suffering from diseases that have a definite effect on pregnancy: including uncontrolled hypertension, heart disease with definite symptoms, uncontrolled diabetes, undefined diagnosis of liver or kidney disease or liver or kidney insufficiency, severe anemia, history of previous venous thrombosis, pulmonary embolism or cerebrovascular events, history of malignant tumors, suspected malignant tumors, and undiagnosed abnormal uterine bleeding.","20 Years",{"count":392,"type":23},980,[26],"To evaluate whether there were significant differences in the effects of constant (5%) versus sequential (5%-2%) oxygen concentration protocols in embryo culture on term live birth rates.\n\nThis study will be conducted in five centers including the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical Universit. 980 women who wish to undergo blastocyst transplantation will be included in the study.\n\nThe study data will be analyzed statistically.",[396,397,398],"Fertility Issues","Blastocyst IVF","Embryo Culture",[397,400],"Fertility","2026-05-29",{"date":204,"type":35},{"date":404,"type":35},"2025-03-01",{"date":406,"type":23},"2027-08-31",{"name":41,"class":42},6,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":17,"sex":77,"minAge":51,"maxAge":154,"enrollmentInfo":415,"targetDuration":417,"studyType":54,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":426,"leadSponsor":428,"locationsCount":43},"100639822","a-prospective-cohort-study-on-the-epidemiological-investigation-diagnosis-and-treatment-of-hepatic-encephalopathy-100639822","NCT07612670","A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy","Inclusion Criteria:\n\n* For patients with liver cirrhosis and the general healthy population, the diagnosis of liver cirrhosis is made by doctors based on imaging, elastography, biopsy or clinical symptoms.\n* The patients themselves and their accompanying family members have smart phones, are proficient in using WeChat and mini-programs, and have a stable network environment.\n* They voluntarily sign the informed consent form, have good compliance, and fully understand this study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old;\n* Women planning to get pregnant, already pregnant or during lactation;\n* Incomplete relevant data information required;\n* Unable to proficiently use WeChat mini-program or unstable network environment;\n* Red-green color blindness or other irreparable visual impairments;\n* Heart, lung, or kidney failure or unstable vital signs;\n* Unwilling to participate in the study or unable to sign the informed consent form;\n* Any other situation that may interfere with the study assessment, increase the risk for the subjects, or affect their completion of the study, as judged by the researcher and deemed unsuitable for participating in this study;\n* Have participated in or are currently participating in other clinical trials within the past 3 months;",{"count":416,"type":23},700,"2 Years","Purpose Hepatic encephalopathy (HE) is a serious complication of liver cirrhosis that can cause memory loss, slow reaction, and even coma. In China, large-scale epidemiological data on HE are lacking, early diagnosis remains difficult, and treatment needs improvement. This study aims to investigate the prevalence of HE in Chinese liver disease patients and to explore better diagnostic methods and treatment strategies.\n\nDesign This is a prospective, multicenter cohort study led by Jiangsu Province Hospital, in collaboration with 7 other hospitals in Jiangsu Province. Between April 2026 and December 2029, the study plans to enroll over 700 patients with liver cirrhosis and 120 healthy volunteers.\n\nWhat participants will do Participants will use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly. They will be followed up at month 1, 3, 6 after enrollment, and then every six months. The research team will collect routine laboratory results, medication records, and quality-of-life data.\n\nBenefits and risks Participants will receive closer health monitoring, which may help detect changes early. The study involves no additional drugs or invasive procedures, so risks are very low. All personal information will be kept strictly confidential and used only for medical research.\n\nVoluntary participation Participation is completely voluntary, and participants can withdraw at any time without affecting their routine medical care.",[420,421,422],"Hepatic Encephalopathy","Minimal Hepatic Encephalopathy","Liver Cirrhosis","2026-05-24",{"date":401,"type":35},{"date":204,"type":23},{"date":427,"type":23},"2028-03-31",{"name":41,"class":42},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":24,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":444,"leadSponsor":445,"locationsCount":43},"100640126","phase-2-efficacy-and-safety-of-polatuzumab-vedotin-in-combination-with-zanubrutinib-rituximab-cyclophosphamide-doxorubicin-and-prednisone-in-patients-with-previously-untreated-diffuse-large-b-cell-lymphoma-of-the-mcdbn2n1-subtypes-100640126","NCT07608978","Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes","Pola-ZRCHP","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD\u002FBN2\u002FN1 molecular subtypes defined by LymphGen classification.\n\nPreviously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥6 months. At least one measurable lesion in two dimensions, defined as a maximum diameter \\>1.5 cm by CT or MRI.\n\nLeft Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).\n\nAdequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic involvement deemed by the investigator to be caused by DLBCL; blood product transfusions are allowed), defined as follows:\n\nHemoglobin ≥9.0 g\u002FdL within 7 days prior to first treatment, without packed RBC transfusion.\n\nAbsolute Neutrophil Count (ANC) ≥1.0 × 10⁹\u002FL. Platelet count ≥75 × 10⁹\u002FL. Female participants of childbearing potential: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate ova.\n\nMale participants: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate sperm.\n\nExclusion Criteria:\n\nContraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding onychomycosis) at screening, or any major infection occurring within 4 weeks prior to the first dose of study treatment (as judged by the investigator).\n\nSuspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the study period or within 12 months after the last dose.\n\nHistory of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of significant, uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of results.\n\nSevere or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D cardiac disease; myocardial infarction within the past 6 months; unstable arrhythmias; or unstable angina.\n\nClinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.\n\nAny of the following abnormal laboratory values (unless these abnormalities are solely attributable to underlying lymphoma):\n\nINR or PT \\>1.5 × Upper Limit of Normal (ULN) in the absence of therapeutic anticoagulation.\n\nPTT or aPTT \\>1.5 × ULN in the absence of lupus anticoagulant. Serum AST and ALT ≥2.5 × ULN. Total bilirubin ≥1.5 × ULN. Estimated creatinine clearance \\\u003C40 mL\u002Fmin (using the Cockcroft-Gault formula). Positive HBV DNA test result. Positive Hepatitis C test result (Hepatitis C virus \\[HCV\\] antibody serology). Note:Patients with positive HCV antibody are eligible only if the PCR test for HCV RNA is negative.\n\nAny other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s).",{"count":260,"type":23},[135],"This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes.\n\nAfter successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT\u002FPET-CT during treatment and after completion of induction. Patients who achieve CR\u002FPR\u002FSD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR\u002FPR\u002FSD) during induction will discontinue the study. Patients with CR\u002FPR\u002FSD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.\n\nEfficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression\u002Frelapse.",[440],"Diffuse Large B-Cell Lymphoma (DLBCL)",{"date":442,"type":35},"2026-05-27",{"date":204,"type":23},{"date":39,"type":23},{"name":41,"class":42},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":154,"enrollmentInfo":453,"targetDuration":4,"studyType":24,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":43},"100639966","phase-1-neoadjuvant-shr-a1811-and-shr-a1701-for-potentially-immunotherapy-sensitive-gc-or-gej-adenocarcinoma-100639966","NCT07581574","Neoadjuvant SHR-A1811 and SHR-A1701 for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma","Trastuzumab Rezetecan Antibody-Drug Conjugate Combined With Retlirafusp α in Patients With HER2-Positive and Potentially Immunotherapy-Sensitive Gastric or Gastroesophageal Junction Adenocarcinoma,a Prospective Phase Ib Trial","Inclusion Criteria:\n\n* Voluntary Participation: The subject voluntarily agrees to participate in this study, is able to sign the informed consent form (ICF), and has good compliance.\n* Age and Gender: Aged 18 to 75 years (at the time of signing the ICF), regardless of gender.\n* Diagnosis and Staging: Histologically and\u002For cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma. Diagnosed as locally advanced according to the AJCC 8th Edition criteria, with cTNM staged as T3-4N+M0 based on endoscopic ultrasound or contrast-enhanced CT\u002FMRI scans (combined with diagnostic laparoscopy if necessary). The subject must agree to undergo radical surgery, and the investigator assesses the lesion as potentially resectable.\n* Treatment History: No prior systemic therapy for the current disease, including anti-tumor radiotherapy, chemotherapy, or immunotherapy.\n* HER2 Status: Confirmed HER2 IHC 3+ or HER2 IHC 2+ with positive FISH result based on endoscopic biopsy tissue IHC results.\n* Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR\u002FMSI-H; at least one of the three criteria must be met.\n* Performance Status: ECOG score of 0-1.\n* Life Expectancy: Estimated life expectancy ≥6 months.\n* Organ Function: Adequate major organ function\n* Contraception and Pregnancy: Subjects of childbearing potential must use appropriate contraception methods during the study and for 120 days after the end of the study. Serum pregnancy test must be negative within 7 days prior to study enrollment, and the subject must not be breastfeeding.\n\nExclusion Criteria:\n\n* Other Malignancies: Concomitant malignant diseases other than gastric cancer (excluding early-stage tumors that have been radically cured).\n* Bleeding Risk: Tumor lesions with a tendency to bleed (e.g., active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months prior to signing the ICF, or judged by the investigator to be at risk of massive gastrointestinal bleeding) or have received blood transfusion therapy within 4 weeks prior to the administration of the study drug.\n* Concurrent Studies: Currently participating in other interventional drug clinical studies, or have received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose.\n* Prior Therapies: Previous exposure to the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 agents, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).\n* Autoimmune Disease: Active autoimmune disease that required systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.\n\nNote: The use of physiological doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n\n* Prior Medication: Received systemic treatment with Traditional Chinese Medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukins, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.\n* Transplant History: Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n* Allergy: Known hypersensitivity to the drugs used in this study.\n* Neuropathy: Peripheral neuropathy ≥ Grade 2.\n* HIV Infection: Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive).\n* Hepatitis: Subjects with active Hepatitis B or Hepatitis C.\n* Vaccination: Received live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).\n\nNote: Inactivated virus vaccines for seasonal influenza (injection) are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted.\n\n* Pregnancy\u002FLactation: Pregnant or breastfeeding women.\n* Uncontrolled Systemic Disease: Presence of any severe or uncontrolled systemic disease.\n* Patients with mental disorders who are unable to cooperate with treatment;\n* Other: Any history or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results or hinder the subject's full participation in the study, or other conditions deemed by the investigator to pose potential risks or make the subject unsuitable for participation in this study.",{"count":454,"type":23},12,[134],"This is a prospective, single-center, single-arm, phase Ib clinical study. It plans to enroll eligible patients with locally advanced gastric\u002Fgastroesophageal junction adenocarcinoma who are HER2-positive and have potential benefit from immunotherapy (PD-L1 CPS≥1, EBV-positive, or dMMR\u002FMSI-H). These patients will receive four cycles of neoadjuvant therapy with Trastuzumab Rezatecan plus Rilafup alfa, followed by radical surgery.\n\nAll subjects will receive the same investigational treatment regimen, with no parallel control group. All enrolled subjects will receive the neoadjuvant treatment regimen of Trastuzumab Rezatecan combined with Retlirafusp alfa. The specific interventions are as follows:\n\n5.1.1 Neoadjuvant Drug Information and Dosing Regimen Trastuzumab Rezatecan Supplier: Jiangsu Hengrui Medicine Co., Ltd. Dosage: 4.8 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Supplier: Jiangsu Hengrui Medicine Co., Ltd. Dosage: 30 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W) The neoadjuvant treatment phase will consist of 4 cycles, with each cycle lasting 21 days, for a total treatment duration of approximately 12 weeks. Imaging examinations will be performed after 2 cycles.\n\n5.1.2 Preoperative Assessment and Surgery Within 4 weeks after the completion of neoadjuvant therapy, patients will undergo imaging examinations for surgical feasibility assessment. Those eligible for surgery will undergo radical gastrectomy (D2 lymphadenectomy) 4-6 weeks after the last dose.\n\nThe primary endpoint is safety and tolerability, specifically including:\n\nPrimary Endpoint:\n\nSafety and Tolerability: including the incidence, type, and severity of dose-limiting toxicities (DLTs); the incidence and treatment-relatedness of adverse events (AEs) and serious adverse events (SAEs); and the determination of the recommended phase II dose (RP2D).\n\nSecondary Endpoints:\n\npCR rate (the percentage of subjects achieving pathological complete response, defined as the absence of residual viable tumor cells in the primary tumor bed); MPR rate (the percentage of subjects achieving major pathological response, defined as ≤10% residual viable tumor cells in the tumor bed); EFS (Event-Free Survival, defined as the time from the initiation of treatment to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence, or death from any cause); R0 resection rate (defined as macroscopically tumor-free surgical margins and microscopically negative tumor cells within 1 mm of the surgical margin); OS (Overall Survival, defined as the time from the start date of neoadjuvant therapy to death from any cause or the date of the last follow-up).\n\nExploratory Endpoints:\n\nInfiltration status of immune cell subsets in tumor tissue before and after treatment.",[458],"Gastric or Gastroesophageal Junction Adenocarcinoma","2026-05-14",{"date":461,"type":35},"2026-05-18",{"date":463,"type":23},"2026-05-01",{"date":465,"type":23},"2029-05-31",{"name":41,"class":42},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":154,"enrollmentInfo":473,"targetDuration":4,"studyType":24,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":43},"100626628","phase-2-a-phase-ii-study-of-hrs-4642-combined-with-ag-nab-paclitaxel-and-gemcitabine-as-conversion-therapy-for-locally-advanced-pancreatic-cancer-100626628","NCT07438106","A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for this study:\n\n1. Age ≥18 years and ≤75 years, regardless of gender.\n2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.\n3. Radiologically confirmed locally advanced disease, defined as:\n\n   1. No distant metastasis.\n   2. Pancreatic head\u002Funcinate process tumors: Tumor contact with the superior mesenteric artery (SMA) \\>180°.\n   3. Pancreatic body\u002Ftail tumors: Tumor contact with the SMA or celiac artery \\>180°; or contact with the celiac artery with aortic invasion; or tumor invasion of the jejunal branches of the SMA.\n   4. Inability to safely reconstruct the portal vein-superior mesenteric vein due to tumor invasion, venous occlusion, or extensive involvement of the jejunal branches of the superior mesenteric vein.\n4. KRAS G12D mutation confirmed by tissue histology or peripheral blood testing.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. No prior antitumor therapy (including radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n7. At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n8. If biliary obstruction is present, it must have been relieved prior to study entry, and the expected survival time is \\>3 months.\n9. Signed written informed consent obtained before performing any study-related procedures.\n10. Adequate organ function meeting the following criteria (without corrective treatment with blood components or growth factors within 14 days prior to the first dose), with test results completed within 7 days before initiation of study treatment:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL.\n    2. White blood cell (WBC) count ≥3.0 × 10\\^9\u002FL.\n    3. Platelets ≥100 × 10\\^9\u002FL.\n    4. Hemoglobin \\>9 g\u002FdL.\n    5. Albumin ≥3.0 g\u002FdL.\n    6. Total bilirubin ≤1.5 × upper limit of normal (ULN).\n    7. Prothrombin time and activated partial thromboplastin time ≤1.5 × ULN.\n    8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.\n    9. Serum creatinine ≤1.5 × ULN or creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 mL\u002Fmin.\n    10. Electrocardiogram: QTcF interval ≤450 msec for males and ≤470 msec for females.\n11. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must not be lactating. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 180 days after the last dose of the study drug (whichever is later). A female is considered not of childbearing potential if postmenopausal for at least 1 year, or surgically sterilized (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if they meet any of the following criteria:\n\n1. Presence of portal hypertension or cavernous transformation of the portal vein; tumor involvement of the gastrointestinal tract causing gastrointestinal bleeding; tumor leading to intra-abdominal fistula or abscess; tumor encasement of the celiac artery or superior mesenteric artery (SMA) with significant vascular wall involvement (moth-eaten appearance).\n2. Diagnosis of malignancies other than pancreatic cancer within 5 years prior to the first dose (excluding radically treated skin basal cell carcinoma, squamous cell carcinoma, and\u002For carcinoma in situ).\n3. History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy.\n4. Current use of systemic corticosteroid therapy (excluding topical, inhaled, nasal, or intra-articular corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. Note: Use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n5. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n6. History of allergy or hypersensitivity considered clinically significant by the investigator.\n7. Presence of clinically significant acute or chronic pancreatitis.\n8. History of drug abuse, chronic alcoholism, or infectious diseases such as AIDS (i.e., HIV-1\u002F2 antibody positive).\n9. Uncontrolled active hepatitis B (defined as HBsAg positive with HBV-DNA level above the upper limit of normal at the local laboratory). Note: Participants with hepatitis B meeting the following criteria may be enrolled: 1) HBV viral load \\\u003C10,000 copies\u002FmL (2,000 IU\u002FmL) prior to the first dose, and the participant should receive anti-HBV therapy throughout the study drug treatment period to prevent reactivation; 2) Participants who are anti-HBc positive, HBsAg negative, anti-HBs negative, and with negative HBV viral load do not require prophylactic anti-HV therapy but require close monitoring for reactivation.\n10. Active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).\n11. Administration of a live attenuated vaccine within 28 days prior to the first study dose or anticipated need for a live attenuated vaccine during the study treatment period. Note: Administration of inactivated seasonal influenza vaccine within 28 days prior to the first dose is permitted; however, live attenuated intranasal influenza vaccines are not allowed.\n12. Major surgery (other than diagnostic biopsy) within 28 days prior to the first dose; minor traumatic surgery (biopsy, endoscopy, and drainage) within 7 days prior to the first dose; presence of non-healing wounds, untreated fractures.\n13. Presence of any severe or uncontrolled systemic disease, for example:\n\n    1. Resting ECG showing significant uncontrolled abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation.\n    2. Unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class ≥II.\n    3. History of any arterial thrombotic, embolic, or ischemic event within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.\n    4. Poorly controlled blood pressure (systolic \\>150 mmHg or diastolic \\>100 mmHg).\n    5. History of non-infectious interstitial lung disease requiring glucocorticoid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n    6. Active tuberculosis.\n    7. Active or uncontrolled infection requiring systemic therapy.\n    8. Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n    9. Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.\n    10. Low-density lipoprotein cholesterol (LDL-C) \\>3.4 mmol\u002FL or severe hypertriglyceridemia (\\>5.7 mmol\u002FL).\n    11. Carotid ultrasound showing stenosis ≥50% or the presence of two or more high-risk characteristic plaques.\n14. History of severe infection within 28 days prior to the first dose, including but not limited to infection complications requiring hospitalization, bacteremia, or severe pneumonia; or active infection requiring therapeutic intravenous antibiotics within 2 weeks before starting study treatment. Participants receiving prophylactic antibiotics (e.g., for urinary tract infection prevention) may be enrolled.\n15. Any history, evidence of disease, treatment, or abnormal laboratory value that, in the investigator's judgment, could interfere with the trial results, prevent the participant from completing the study, indicate poor compliance, or pose potential risks making the participant unsuitable for study participation.",{"count":110,"type":23},[135],"This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer.\n\nParticipants will undergo regular assessments, including imaging scans and CA19-9 biomarker tests. If disease recurrence is suspected, unscheduled evaluations may be performed. For participants who discontinue treatment due to reasons other than disease progression (e.g., toxicity), tumor assessments will continue as scheduled until progression, loss to follow-up, death, consent withdrawal, or study termination.\n\nAfter the final treatment, participants will enter a survival follow-up phase. Investigators will contact the participants or their families approximately every month (±7 days) to collect information on survival status (date and cause of death) and any subsequent anti-cancer treatments until death, loss to follow-up, study termination, or other study endpoints are met. All follow-up information will be documented in the medical records.",[477],"Locally Advanced Pancreatic Cancer With KRAS G12D Mutation","2026-05-13",{"date":480,"type":35},"2026-05-15",{"date":482,"type":35},"2026-01-28",{"date":484,"type":23},"2027-12",{"name":41,"class":42},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":258,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":43},"100623265","phase-2-neoadjuvant-study-of-hifu-with-or-without-pd-1-inhibitors-followed-by-abraxane-plus-carboplatin-in-triple-negative-breast-cancer-100623265","NCT07394387","Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.","A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.","Inclusion Criteria:\n\n1. Female patients aged ≥18 and ≤70 years.\n2. Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC TNM staging.\n3. At least one measurable lesion as per RECIST v1.1 criteria.\n4. No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function, defined as:\n\n   * Hemoglobin ≥90 g\u002FL\n   * White blood cell count ≥3.5×10\\^9\u002FL\n   * Platelet count ≥100×10\\^9\u002FL\n   * Absolute neutrophil count ≥1.5×10\\^9\u002FL\n   * AST and ALT ≤3× upper limit of normal (ULN)\n   * Total bilirubin ≤1.5× ULN\n   * Serum creatinine ≤1.5× ULN\n   * No evidence of pneumonia on chest CT\n7. Adequate cardiac function, defined as:\n\n   * No myocardial ischemia on ECG\n   * NYHA class I\n   * LVEF ≥55% on echocardiogram\n   * Normal cardiac markers (cTnI and BNP)\n8. Normal thyroid function (T3, T4, FT3, FT4, TSH).\n9. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Male or inflammatory breast cancer.\n2. Metastatic (Stage IV) breast cancer.\n3. History of active autoimmune or inflammatory diseases requiring systemic treatment within the past 2 years (e.g., systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis). Exceptions: type I diabetes, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis).\n4. Concurrent other malignancies or history of other malignancies within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix).\n5. Any other serious non-malignant disease that may compromise compliance or place the patient at risk.\n6. Major surgery within 4 weeks prior to study initiation or anticipated need for major surgery during the study.\n7. Prior radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major surgery for breast cancer.\n8. Known hypersensitivity to any component of the study drugs.\n9. Poorly controlled cardiac disease (e.g., NYHA class II+ heart failure, unstable angina, myocardial infarction within the past year, or clinically significant arrhythmias requiring intervention).\n10. History of interstitial lung disease (ILD), current ILD, or suspected ILD on imaging during screening.\n11. Active infections, including:\n\n    * HIV positive\n    * Active tuberculosis\n    * Active hepatitis B (HBV-DNA \\> 10\\^3 IU\u002FmL)\n    * Active hepatitis C (HCV antibody positive with detectable HCV-RNA)\n12. Active autoimmune disease requiring systemic treatment.\n13. Dementia, significant intellectual impairment, or any psychiatric condition that impairs understanding of the informed consent.\n14. Unhealed wounds, ulcers, or fractures within 4 weeks prior to signing consent; or any history of clinically significant bleeding or bleeding tendency.\n15. Any other condition deemed by the investigator to be unsuitable for trial participation.",{"count":494,"type":23},58,[135],"Background:\n\nTriple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and\u002For PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment effectiveness. This study aims to investigate this new approach.\n\nObjective:\n\nTo evaluate the effectiveness and safety of using HIFU, with or without a PD-1 inhibitor (Sintilimab), before and during combination chemotherapy in patients with early-stage TNBC. The primary goal is to determine if this strategy can increase the rate of pathological complete response (pCR).\n\nStudy Design:\n\nThis is a single-center, Phase II clinical study. Approximately 40 participants with Stage II-III TNBC will be enrolled and assigned to one of two groups (cohorts) without randomization:\n\nCohort A: Receives HIFU treatment. Two weeks later, begins standard chemotherapy (Abraxane and carboplatin) combined with the PD-1 inhibitor Sintilimab for 6 cycles.\n\nCohort B: Receives HIFU treatment combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, begins the same 6 cycles of chemotherapy (Abraxane and carboplatin) combined with Sintilimab.\n\nMain Measures:\n\nThe primary measure is the rate of pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes after surgery following the completion of neoadjuvant therapy.\n\nOther important measures include:\n\nThe ability of the treatment to activate the immune system (measured by changes in CD8+ T cells or IFN-γ).\n\nThe percentage of patients whose tumors shrink significantly (Objective Response Rate).\n\nHow long patients live without their cancer getting worse (Event-Free Survival).\n\nThe rate of patients who can undergo breast-conserving surgery. The frequency and severity of side effects.",[498],"Triple Negative Breast Cancer (TNBC)",{"date":480,"type":35},{"date":501,"type":35},"2025-01-01",{"date":503,"type":23},"2026-12-31",{"name":41,"class":42},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":20,"enrollmentInfo":513,"targetDuration":4,"studyType":24,"phases":515,"briefSummary":516,"conditions":517,"keywords":520,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":43},"100520827","a-randomized-controlled-trial-of-lot-crt-versus-conventional-bivp-in-heart-failure-patients-with-nicd-100520827","NCT06061627","A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD","A Randomized Controlled Trial of Left Bundle brAnch opTimized Cardiac Resynchronization Therapy Versus conventionaL Bi-vEntricular Pacing in Heart Failure Patients With Nonspecific Intraventricular Conduction Delay","BATTLE","Inclusion Criteria:\n\n1. Ischemic or non ischemic cardiomyopathy\n2. Optimal medical therapy for at lest 3 months\n3. NYHA class II-IV\n4. LVEF≤35% as assessed by echocardiography\n5. Sinus rhythm (may have paroxysmal atrial fibrillation)\n6. QRS duration ≥ 150ms\n7. Intraventricular block (NICD), QRS morphology is neither LBBB nor RBBB\n\nExclusion Criteria:\n\n1. Valvular heart disease that requires or has undergone surgical intervention\n2. After mechanical tricuspid valve replacement\n3. Persistent or permanent atrial fibrillation or atrial flutter\n4. Second or third degree atrioventricular block\n5. Have a history of acute myocardial infarction within 3 months prior to enrollment\n6. Patient's expected survival time is less than 12 months\n7. Pregnant or planned to conceive\n8. Ventricular septal hypertrophy (ventricular septal thickness exceeds 15mm at the end of diastole)\n9. Patients with simple and persistent left superior vena cava\n10. Patients with existing pacemaker implantation",{"count":514,"type":23},86,[26],"BATTLE study has been designed as a prospective, multi-center, randomized, controlled trial. This study will enroll 83 patients with chronic heart failure accompanied by intraventricular block (NICD) over an estimated recruitment period of 3 years. An LOT-CRT group will be compared with a group of conventional BiVP in the follow-up of at least 6 months. The study aimed to compare the curative effect of LOT-CRT in preserving LV systolic function with traditional BiVP in chronic heart failure patients with NICD.",[518,519],"Heart Failure","Intraventricular Block",[521],"Left bundle branch area pacing","2026-05-12",{"date":459,"type":35},{"date":525,"type":35},"2023-09-21",{"date":527,"type":23},"2027-03",{"name":41,"class":42},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":24,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":4},"100641095","phase-4-trastuzumab-rezetecan-t-dxh-in-her2-breast-cancer-with-non-pcr-after-tcbhp-100641095","NCT07589699","Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP","A Single-Arm, Exploratory Study of 4 Additional Cycles of Trastuzumab Rezetecan (T-DXh) as Neoadjuvant Therapy in Patients With Early or Locally Advanced HER2-Positive Breast Cancer Who Have Non-pCR After TCbHP Neoadjuvant Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.\n* Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).\n* Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).\n* Agree to undergo a core needle biopsy.\n* ECOG performance status 0 or 1.\n* Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, AST\u002FALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.\n* No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Male breast cancer or inflammatory breast cancer.\n* Metastatic breast cancer (Stage IV).\n* Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Concurrent other anti-tumor therapy or participation in another clinical trial.\n* Severe non-malignant disease that would affect compliance or place the patient at risk.\n* Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.\n\nHistory of allergic reaction or contraindication to any component of the study drug.\n\n* Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent.\n* Any other condition assessed by the investigator as unsuitable for inclusion.",{"count":368,"type":23},[81],"This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg\u002Fkg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.",[57,540,541,542],"HER2-positive Breast Cancer","Early-stage Breast Cancer","Locally Advanced Breast Cancer","2026-05-11",{"date":480,"type":35},{"date":546,"type":23},"2026-05-31",{"date":548,"type":23},"2031-12-31",{"name":41,"class":42},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":77,"minAge":51,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":24,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":408},"100593105","phase-1-the-cd19cd20-dual-target-in-vivo-car-t-lentiviral-product-in-the-treatment-of-relapsedrefractory-b-cell-malignancies-100593105","NCT07002112","The CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.\n2. Age greater than or equal to 18.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. At least one evaluable tumor lesion.\n5. Relapsed and\u002For refractory NHL , and relapsed and\u002For refractory CLL with treatment indications\n6. Life expectancy≥ 3 months\n7. Clinical laboratory values meet screening visit criteria\n8. Adequate organ function;\n\nExclusion Criteria:\n\nSubject eligible for this study must not meet any of the following criteria:\n\n1. Prior antitumor therapy with insufficient washout period ;\n2. Prior treatment with lentiviral vector-based gene therapies;\n3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).\n4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).\n5. Lactating women;",{"count":110,"type":23},[134],"A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies.",[351],{"date":459,"type":35},{"date":563,"type":35},"2025-05-23",{"date":565,"type":23},"2029-06-30",{"name":41,"class":42},""]