[{"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:":554},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,241,0,25,[9,42,64,86,116,139,163,185,205,232,256,276,294,314,332,350,372,394,416,437,459,477,500,520,538],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100652536","phase-2-adjuvant-therapy-for-potentially-immunotherapy-responsive-gastric-or-gastroesophageal-junction-adenocarcinoma-100652536",false,"NCT07772557","Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma","Efficacy and Safety of Serplulimab Combined With Short-Course SOX Regimen Versus SOX Regimen Alone as Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Randomized Controlled Trial","ALTER-SOX","Inclusion Criteria:\n\n* The patient voluntarily joins this study and signs the informed consent form.\n* Age ≥18 years and ≤75 years, male or female.\n* Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (predominantly adenocarcinoma) with stage II-III disease (TNM staging, 8th UICC\u002FAJCC) who have not received preoperative neoadjuvant therapy.\n* ECOG performance status: 0-1.\n* Postoperative testing of gastric cancer specimens indicates: PD-L1 CPS ≥5, or EBV-positive, or dMMR.\n* No prior anti-tumor therapy for gastric cancer, including chemotherapy, targeted therapy, immunotherapy, or local radiotherapy.\n* Female patients of childbearing potential (not surgically sterilized) must use a medically acceptable contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment. Female patients of childbearing potential must have a negative serum or urine HCG test within 72 hours prior to study enrollment and must not be breastfeeding. Male patients must be surgically sterilized or agree to use an appropriate contraceptive method during the study period and for 3 months after the last dose of the investigational drug.\n* Baseline hematological and biochemical parameters must meet the following criteria:\n\nHemoglobin ≥90 g\u002FL; Absolute neutrophil count ≥1.5×10⁹\u002FL; Platelet count ≥100×10⁹\u002FL; Hepatic function: ALT ≤2.5×ULN, AST ≤2.5×ULN, TBIL ≤1.5×ULN (for patients with liver metastases: ALT ≤5×ULN, AST ≤5×ULN, TBIL ≤3×ULN); Renal function: Creatinine ≤1.5×ULN, or when creatinine \\>1.5×ULN, endogenous creatinine clearance \\>50 mL\u002Fmin; Alkaline phosphatase ≤2.5×ULN; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, T3 and T4 levels should be evaluated; patients may be enrolled if T3 and T4 levels are within normal limits).\n\nExclusion Criteria:\n\n* The patient voluntarily joins this study and signs the informed consent form. (Note: This item appears to be an inclusion criterion and is likely misplaced. Please verify.)\n* Pregnant or breastfeeding women.\n* Women of childbearing potential with a positive baseline pregnancy test.\n* Distant metastasis diagnosed by CT\u002FMRI\u002FEUS.\n* Prior anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.\n* Diagnosis of another malignancy within the past 5 years (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer).\n* Uncontrolled pleural effusion, pericardial effusion, or ascites.\n* Severe cardiovascular disease within 12 months prior to enrollment, such as symptomatic coronary artery disease, congestive heart failure ≥ Class II, uncontrolled arrhythmia, or myocardial infarction.\n* Concurrent upper gastrointestinal obstruction\u002Fbleeding, or digestive dysfunction\u002Fmalabsorption syndrome that may affect the absorption of S-1.\n* Concurrent severe uncontrolled infection or other severe uncontrolled concomitant disease, moderate or severe renal impairment.\n* History of allergic reactions to any of the study drugs.\n* Use of corticosteroids or other systemic immunosuppressive therapy within 14 days prior to enrollment.\n* Receipt of an investigational drug within 4 weeks prior to enrollment (participation in another clinical trial).\n* Active autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy). Subjects with hypothyroidism requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), may be enrolled.\n* History of primary immunodeficiency.\n* Use of immunosuppressive agents within 4 weeks prior to the first dose of study treatment, excluding nasal sprays, inhaled, or other topical corticosteroids, or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent), or prophylactic use of corticosteroids for contrast allergy.\n* Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment, or planned receipt during the study period.\n* Known interstitial pneumonia or active pulmonary tuberculosis.\n* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Positive HIV antibody, active hepatitis B or hepatitis C (hepatitis B: HBsAg positive and HBV-DNA ≥10⁴ copies\u002FmL; hepatitis C: HCV antibody and HCV-RNA positive, requiring concurrent antiviral therapy).\n* Other factors that, in the investigator's judgment, may affect subject safety or trial compliance, such as severe concomitant disease requiring treatment (including psychiatric disorders), severe laboratory abnormalities, or other family or social factors.","ALL","18 Years","75 Years",{"count":22,"type":23},108,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","This study evaluates the clinical efficacy and safety benefits of immunotherapy in a selected patient population by comparing serplulimab combined with short-course SOX regimen versus SOX regimen alone as adjuvant therapy for patients with stage pII-III gastric or gastroesophageal junction (G\u002FEGJ) adenocarcinoma who are PD-L1 CPS ≥5, EBV-positive, or dMMR\u002FMSI-H.",[29],"Gastric or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-08-17",{"date":33,"type":34},"2026-08-19","ACTUAL",{"date":36,"type":23},"2026-09-01",{"date":38,"type":23},"2032-01-20",{"name":40,"class":41},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":48,"targetDuration":4,"studyType":24,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"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":49,"type":23},30,[26],"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.",[53],"Locally Advanced Pancreatic Cancer With KRAS G12D Mutation","RECRUITING","2026-08-10",{"date":57,"type":34},"2026-08-12",{"date":59,"type":34},"2026-01-28",{"date":61,"type":23},"2027-12",{"name":40,"class":41},1,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":24,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":63},"100651717","phase-1-cd19cd20-dual-target-in-vivo-car-t-lentiviral-product-in-the-treatment-of-relapsedrefractory-b-cell-malignancies-100651717","NCT07763938","CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Phase Ib 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 measurable tumor lesion.\n5. Eligible subjects shall meet the criteria and qualification requirements of any one of the expansion cohorts as follows:\n\n   * Cohort 1: Relapsed or refractory large B-cell lymphoma patients who have received at least one line of systemic therapy and have not undergone CAR-T therapy;\n   * Cohort 2: High-risk large B-cell lymphoma patients in the first-line setting (who have completed 2 cycles of standard first-line systemic immunochemotherapy);\n   * Cohort 3: Relapsed or refractory mantle cell lymphoma patients treated with at least two lines of systemic therapy;\n   * Cohort 4: Exploratory cohort including relapsed or refractory indolent lymphoma and other B-cell malignancies.\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":72,"type":23},80,[74],"PHASE1","Phase Ib 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",[77],"Relapsed\u002FRefractory B-cell Malignancies","2026-08-09",{"date":80,"type":34},"2026-08-13",{"date":82,"type":23},"2026-11-01",{"date":84,"type":23},"2032-12-30",{"name":40,"class":41},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":24,"phases":96,"briefSummary":98,"conditions":99,"keywords":107,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":63},"100622004","safety-and-efficacy-of-esketamine---dexmedetomidine-combination-versus-dexmedetomidine-monotherapy-for-hyperactive-delirium-in-icu-patients-on-non-invasive-respiratory-support-essential-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 (ESSENTIAL Trial): Study Protocol of a Randomized Controlled Trial","ESSENTIAL","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.","80 Years",{"count":95,"type":23},388,[97],"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.",[100,101,102,103,104,105,106],"Dexmedetomidine","Ketamine","Analgesia","Respiratory Therapy","Intensive Care Units (ICUs)","Agitation","Sedation and Analgesia",[108,102,105,100,101,104,103],"Sedation and analgesia","2026-08-06",{"date":55,"type":34},{"date":112,"type":23},"2026-08-01",{"date":114,"type":23},"2029-01-01",{"name":40,"class":41},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":24,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":63},"100650502","phase-2-the-efficacy-of-capct-in-patients-with-ptcl-100650502","NCT07746245","The Efficacy of CAPCT in Patients With PTCL","Multicenter, Single-Arm, Open-Label Clinical Study to Observe the Efficacy of Chidamide Combined With Azacitidine, Prednisone, Cyclophosphamide, and Thalidomide in Patients With Peripheral T-Cell Lymphoma (PTCL) Who Are Intolerant to Standard Chemotherapy.","Inclusion Criteria:\n\n* 1\\. Patients with histopathologically confirmed peripheral T-cell lymphoma (PTCL), with exclusion of NK\u002FT-cell lymphoma.\n* 2\\. Patients who are treatment-naïve or have relapsed\u002Frefractory disease.\n* 3\\. Patients who are intolerant to standard chemotherapy regimens for various reasons, including those aged ≥75 years, or those aged \\\u003C75 years but deemed by the investigator to be unsuitable for or unable to tolerate chemotherapy.\n* 4\\. Patients aged ≥18 years, male or female.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.\n* 6\\. Absolute neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥50×10⁹\u002FL, and hemoglobin ≥70 g\u002FL.\n* 7\\. Estimated life expectancy ≥3 months.\n* 8\\. Voluntary signing of written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or lactating women, or fertile patients of childbearing potential who are unwilling to adopt contraceptive measures.\n* 2\\. Patients with chronic heart failure of New York Heart Association (NYHA) functional class III or IV; or those with a history of any of the following cardiac conditions within 6 months: acute coronary syndrome; acute heart failure (NYHA functional class III or IV); or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or sudden cardiac death after resuscitation).\n* 3\\. Hepatic dysfunction (total bilirubin \\>1.5× the upper limit of normal \\[ULN\\]; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\>2.0× ULN, or \\>5× ULN in patients with hepatic involvement); or renal dysfunction (serum creatinine \\>1.5× ULN).\n* 4\\. Confirmed central nervous system (CNS) involvement by lymphoma.\n* 5\\. Receipt of prior myelosuppressive symptomatic treatment within 7 days before enrollment.\n* 6\\. Active hemorrhage\u002Fbleeding.\n* 7\\. Patients with acquired immunodeficiency syndrome (AIDS), syphilis, or active hepatitis B (HBV DNA \\>1×10⁵ copies\u002FmL) or hepatitis C.\n* 8\\. Receipt of grade II or higher surgery within 3 weeks prior to treatment.\n* 9\\. Psychiatric disorders or inability to provide informed consent.\n* 10\\. Patients deemed by the investigator to be unsuitable for participation in this trial.\n* 11\\. Known allergy to any component of the investigational drug.",{"count":124,"type":23},58,[26],"This study is a multicenter, single-arm, non-randomized, open-label trial designed to evaluate the efficacy and safety of chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) in patients with peripheral T-cell lymphoma (PTCL). A total of 58 patients with PTCL are planned to be enrolled after providing written informed consent and meeting all eligibility criteria. Enrolled patients will receive the CAPCT regimen, with each cycle consisting of 21 days, for a total of 6 cycles. Participants who do not experience disease progression or unacceptable toxicity after 6 cycles of combination therapy will continue to receive the CPCT regimen (chidamide combined with prednisone, cyclophosphamide, and thalidomide) for up to 6 months, followed by chidamide monotherapy as maintenance treatment. The primary efficacy endpoint is objective response rate (ORR).",[128],"Peripheral T-Cell Lymphoma",[130,131],"PTCL","HDACi","2026-07-30",{"date":134,"type":34},"2026-08-05",{"date":112,"type":23},{"date":137,"type":23},"2029-07-31",{"name":40,"class":41},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":146,"targetDuration":4,"studyType":24,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":63},"100567899","comparing-the-incidence-of-parastomal-hernia-after-mesenteric-molding-suturing-and-non-molding-suturing-in-colostomy-surgery-100567899","NCT06674187","Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery","A Prospective Randomized Controlled Trial Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery","Inclusion Criteria:\n\n* Age 18 years or older.\n* Patients requiring colostomy surgery.\n* Ability to provide written informed consent.\n* Expected survival of more than one year.\n* No severe comorbidities such as heart, lung, liver, or kidney dysfunction.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* History of major abdominal surgery that could affect the development of PSH.\n* Mental illness that impairs understanding of the study content and ability to give informed consent.\n* Patients receiving immunosuppressive therapy or chemotherapy.",{"count":147,"type":23},234,[149],"NA","\\*\\*Research Background\\*\\*\n\nColostomy surgery is a common surgical procedure widely used for the treatment of various gastrointestinal diseases, including rectal cancer, ulcerative colitis, and Crohn's disease. Although this surgery can significantly improve patients' quality of life and prognosis, the incidence of postoperative complications, particularly parastomal hernia (PSH), is relatively high. PSH refers to the formation of an abdominal wall hernia around the stoma, with an incidence rate that can reach up to 50%. PSH not only affects patients' quality of life but can also lead to pain, stoma dysfunction, and the need for reoperation, increasing medical costs and patient burden. Therefore, how to effectively prevent PSH has become an important topic in clinical research.\n\n\\*\\*Epidemiology of Parastomal Hernia\\*\\*\n\nThe incidence of PSH varies across different studies, ranging from 10% to 50%. This variation may be due to differences in study design, patient characteristics, and surgical techniques. A systematic review and meta-analysis showed that the incidence of PSH differs significantly among different surgical techniques, with higher rates observed in traditional non-molding suturing techniques. Another large cohort study found that the incidence of PSH varies among different age groups and patients with different underlying diseases, suggesting that PSH occurrence may be influenced by multiple factors.\n\n\\*\\*Risk Factors for Parastomal Hernia\\*\\*\n\n1. \\*\\*Patient Factors\\*\\*:\n\n   * \\*\\*Advanced Age\\*\\*: Older patients have reduced tissue elasticity and muscle strength, making them more susceptible to PSH.\n   * \\*\\*Obesity\\*\\*: Obese patients have higher intra-abdominal pressure, increasing the risk of PSH.\n   * \\*\\*Smoking\\*\\*: Smoking impairs wound healing, increasing the risk of PSH.\n   * \\*\\*Chronic Obstructive Pulmonary Disease (COPD)\\*\\*: COPD patients often experience coughing and breathing difficulties, leading to increased intra-abdominal pressure and a higher risk of PSH.\n   * \\*\\*Diabetes\\*\\*: Diabetic patients have poorer wound healing capabilities, making them more prone to PSH.\n   * \\*\\*Malnutrition\\*\\*: Malnutrition impairs tissue repair, increasing the risk of PSH.\n2. \\*\\*Surgical Factors\\*\\*:\n\n   * \\*\\*Surgical Technique\\*\\*: Different surgical techniques have a significant impact on the incidence of PSH. Traditional non-molding suturing techniques, which lack support for the tissues around the stoma, have a higher incidence of PSH.\n   * \\*\\*Stoma Location\\*\\*: Improper stoma placement, such as outside the rectus abdominis muscle, increases the risk of PSH.\n   * \\*\\*Stoma Size\\*\\*: An oversized or undersized stoma can affect stoma function and increase the risk of PSH.\n   * \\*\\*Use of Mesh\\*\\*: Using synthetic or biological mesh can significantly reduce the incidence of PSH. However, the use of mesh may bring risks of infection and other complications.\n3. \\*\\*Postoperative Factors\\*\\*:\n\n   * \\*\\*Early Mobilization\\*\\*: Appropriate early mobilization promotes circulation and wound healing, but excessive activity can increase intra-abdominal pressure and the risk of PSH.\n   * \\*\\*Increased Intra-abdominal Pressure\\*\\*: Activities such as coughing, constipation, and heavy lifting can increase intra-abdominal pressure and the risk of PSH.\n   * \\*\\*Infection\\*\\*: Postoperative infections can impair wound healing and increase the risk of PSH.\n\n\\*\\*Prevention Strategies for Parastomal Hernia\\*\\*\n\n1. \\*\\*Improvement in Surgical Techniques\\*\\*:\n\n   * \\*\\*Mesenteric Molding Suturing\\*\\*: In recent years, mesenteric molding suturing has gained attention due to its potential advantages. Mesenteric molding suturing strengthens the support around the stoma, reducing the protrusion of abdominal contents and thus lowering the incidence of PSH. A retrospective study showed that patients who underwent mesenteric molding suturing had a significantly lower incidence of PSH compared to those who received traditional non-molding suturing. However, these studies are mostly retrospective and have certain biases and limitations, lacking high-quality prospective randomized controlled trials to validate these findings.\n   * \\*\\*Use of Mesh\\*\\*: Some studies have shown that using synthetic or biological mesh can significantly reduce the incidence of PSH. The mesh provides additional support, reducing the protrusion of abdominal contents and thus lowering the risk of PSH. However, the use of mesh may bring risks of infection and other complications, requiring a careful balance of benefits and risks.\n2. \\*\\*Postoperative Care\\*\\*:\n\n   * \\*\\*Early Mobilization Guidance\\*\\*: Appropriate early mobilization promotes circulation and wound healing, but excessive activity should be avoided to prevent increased intra-abdominal pressure.\n   * \\*\\*Avoidance of Increased Intra-abdominal Pressure\\*\\*: Patients should be advised to avoid activities that can increase intra-abdominal pressure, such as coughing, constipation, and heavy lifting.\n   * \\*\\*Infection Prevention\\*\\*: Keeping the stoma area clean and dry and promptly managi",[152],"Parastomal Hernia",[154,152],"Colostomy Surgery","2026-07-25",{"date":157,"type":34},"2026-07-28",{"date":159,"type":34},"2024-12-01",{"date":161,"type":23},"2027-12-31",{"name":40,"class":41},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":170,"targetDuration":4,"studyType":24,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":63},"100370063","total-meso-rectal-excision-versus-transanal-local-excision-followed-by-radiotherapy-for-t2n0m0-distal-rectal-cancer-100370063","NCT04098471","Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer","Total Mesorectal Excision Versus Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: a Multicenter Randomized Trial","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Histologically confirmed adenocarcinoma by preoperative biopsy.\n* Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy.\n* Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination.\n* Clinical stage T2 rectal cancer confirmed by preoperative high-resolution pelvic MRI.\n* No radiological evidence of suspicious lymph node metastasis or distant metastasis on preoperative contrast-enhanced computed tomography (CT) and MRI.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* History of other malignant tumors within the past 5 years.\n* Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination.\n* Multiple primary colorectal tumors.\n* Pregnant or breastfeeding women.\n* Patients with plans for pregnancy.\n* Severe psychiatric disorders.\n* Previous treatment for rectal cancer, including radiotherapy or chemotherapy.\n* Concomitant intestinal diseases, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active ulcerative colitis, or Crohn's disease.\n* Poor general condition or uncontrolled serious comorbidities that may affect study participation or treatment.\n* Contraindications to laparoscopic surgery, including extensive intra-abdominal adhesions caused by previous abdominal surgery or inability to tolerate pneumoperitoneum.\n* Current participation in another clinical trial.",{"count":171,"type":23},168,[149],"A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer",[175],"Rectal Cancer",[177,178],"transanal endoscopic microsurgery","T2N0M0",{"date":157,"type":34},{"date":181,"type":34},"2021-10-01",{"date":183,"type":23},"2030-06-01",{"name":40,"class":41},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":192,"minAge":19,"maxAge":93,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":63},"100649226","phase-2-neoadjuvant-short-course-hypofractionated-radiotherapy-plus-adebrelimab-and-platinum-chemotherapy-in-locally-advanced-cervical-cancer-a-single-arm-phase-ii-trial-100649226","NCT07731828","Neoadjuvant Short-course Hypofractionated Radiotherapy Plus Adebrelimab and Platinum Chemotherapy in Locally Advanced Cervical Cancer: A Single-arm Phase II Trial","A Single-arm, Phase II Study of Short-course Hypofractionated Radiotherapy Combined With Adebrelimab and Single-agent Platinum Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* Signed informed consent form prior to any study-specific procedure.\n\nFemale aged 18 to 80 years (inclusive) at the time of signing informed consent.\n\nHistopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n\nClinical staging of IB3-IIA2, or IIIA without parametrial invasion (according to FIGO 2018 staging system); no pelvic lymph node metastasis confirmed by PET\u002FCT, and no evidence of distant metastasis.\n\nNo prior surgery, radiotherapy, or systemic anti-tumor therapy for locally advanced cervical cancer (LACC).\n\nAt least one measurable lesion meeting RECIST 1.1 evaluation criteria.\n\nECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n\nAdequate hematological, hepatic, and renal function within 14 days prior to enrollment (details to be confirmed in the full protocol).\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or women who intend to become pregnant during the study period and are unwilling to use effective contraception.\n\nKnown hypersensitivity to adebrelimab, platinum-based drugs (cisplatin or carboplatin), or any component of the concomitant regimens.\n\nHistory of other malignant tumors within 5 years prior to enrollment, except for cured non-melanoma skin cancer or cervical intraepithelial neoplasia.\n\nUncontrolled severe cardiovascular disease (e.g., NYHA Class III or IV heart failure, unstable angina pectoris, uncontrolled arrhythmias, or myocardial infarction within 6 months).\n\nActive autoimmune disease requiring systemic immunosuppressive or corticosteroid therapy.\n\nKnown active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or uncontrolled HIV infection.\n\nUncontrolled severe infection requiring systemic antibiotic\u002Fantiviral therapy at enrollment.\n\nPrior participation in other clinical trials and received investigational drug within 4 weeks before enrollment.\n\nConcomitant disease or condition that, in the judgment of the Investigator, would place the subject at undue risk or interfere with the subject's participation in the trial or interpretation of trial results.","FEMALE",{"count":194,"type":23},35,[26],"Brief Summary\n\nA Phase II Single-Arm Clinical Trial of Short-Course Radiotherapy Combined with Adebrelimab and Platinum-Based Neoadjuvant Therapy for Locally Advanced Cervical Cancer\n\nBackground \\& Objective:\n\nThis is a single-center, single-arm, Phase II clinical trial. The primary objective is to evaluate the pathological complete response (pCR) rate (defined as ypT0N0) following neoadjuvant therapy with short-course radiotherapy (SCRT) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and single-agent platinum chemotherapy in patients with locally advanced cervical cancer (LACC).\n\nStudy Design:\n\nPatients will receive SCRT followed by three cycles of neoadjuvant chemoimmunotherapy. After completion of neoadjuvant treatment, radical hysterectomy with pelvic lymphadenectomy (with or without para-aortic lymphadenectomy) will be performed.\n\nOutcome Measures:\n\nPrimary Endpoint: Pathological Complete Response (pCR) rate assessed by a central pathologist.\n\nSecondary Endpoints:\n\nObjective Response Rate (ORR) and R0 resection rate (per RECIST 1.1).\n\nEvent-Free Survival (EFS) and 2-year EFS rate.\n\nIncidence and severity of Treatment-Related Adverse Events (TRAEs, per NCI-CTCAE v5.0) and surgical complications (per Clavien-Dindo classification).\n\nFeasibility and implementation rate of different adjuvant treatment strategies based on postoperative risk stratification.\n\nDepth of response (major pathological response, MPR).\n\nInclusion Criteria:\n\nKey eligibility criteria include:\n\nNewly diagnosed, histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.\n\nClinical stage IB3-IIA2 or IIIA (without parametrial invasion) per FIGO 2018 staging.\n\nNo evidence of extrapelvic lymph node metastasis or distant metastasis (confirmed by PET\u002FCT or enhanced CT).\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",[198],"Cervical Neoplasms","2026-07-23",{"date":157,"type":34},{"date":112,"type":23},{"date":203,"type":23},"2028-08-01",{"name":40,"class":41},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":24,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},"100648368","phase-2-orelabrutinib-combined-with-obinutuzumab-and-short-course-venetoclax-in-patients-with-treatment-nave-mantle-cell-lymphoma-mcl-100648368","NCT07719556","Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL)","A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study of Orelabrutinib in Combination With Obinutuzumab and Short-course Venetoclax in Patients With Treatment-naïve Mantle Cell Lymphoma (MCL)","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form;\n2. Age ≥ 18 years, male or female;\n3. Life expectancy ≥ 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients with ECOG 3 may be enrolled only if the decline in performance status is attributed to the underlying disease and the investigator determines that they may benefit from the treatment;\n5. Pathologically confirmed diagnosis of mantle cell lymphoma (MCL) and treatment-naïve;\n6. Presence of measurable and\u002For evaluable lymphoma lesions;\n7. Adequate bone marrow reserve, defined as: absolute neutrophil count \\> 1.0×10⁹\u002FL or platelet count \\> 75×10⁹\u002FL, unless cytopenias are considered to be related to bone marrow involvement by lymphoma and deemed recoverable by the investigator;\n8. Hepatic function: AST (SGOT) and ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN) (in the absence of liver involvement) or ≤ 5 × ULN (in the presence of liver involvement); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;\n9. Creatinine clearance ≥ 30 mL\u002Fmin, calculated using the Cockcroft-Gault formula;\n10. Able to comply with the study visit schedule and other protocol requirements;\n11. All patients of childbearing potential must agree to use effective contraceptive measures during the study and for 24 months after study treatment discontinuation. Female patients of childbearing potential must have a negative urine pregnancy test prior to the first dose of study treatment.\n\nExclusion Criteria:\n\n1. Received prior treatment for lymphoma within 2 weeks before study enrollment;\n2. Any serious medical condition, including but not limited to:\n\n   * Uncontrolled hypertension (defined as blood pressure that remains uncontrolled after at least 4 weeks of treatment with a reasonable and tolerable regimen of 3 or more antihypertensive agents \\[including diuretics\\] at adequate doses, or requiring 4 or more antihypertensive agents to achieve adequate control);\n\n     * Uncontrolled congestive heart failure within 6 months prior to screening (New York Heart Association \\[NYHA\\] Class III \\[moderate\\] or Class IV \\[severe\\] cardiac disease);\n\n       * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n         * Symptomatic coronary artery disease (e.g., chest tightness, chest pain, palpitations, fatigue) or coronary artery disease requiring medical therapy; ⑤Severe bradycardia (heart rate \\\u003C 40 beats per minute \\[bpm\\]) with hypotension, dizziness, or syncope; patients with a history of arrhythmia should undergo cardiac evaluation;\n\n           * Known active bacterial, viral, fungal, or other infection (excluding fungal infection of the nail bed), or major infection within 2 weeks prior to the first dose of study drug;\n\n             * Moderate to severe hepatic impairment (Child-Pugh Class B or C); ⑧Active bleeding within 2 months prior to screening, or clear evidence of bleeding diathesis as judged by the investigator; ⑨Current pulmonary disease that impairs lung function, such as pulmonary fibrosis or drug-related pneumonitis, which is deemed intolerable by the investigator; ⑩Any psychiatric or cognitive disorder that may limit the patient's ability to understand, execute, or comply with the informed consent and study requirements;\n3. Known active hepatitis C virus (HCV) infection; or other acquired or congenital immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) infection;\n4. All patients with central nervous system (CNS) involvement by lymphoma;\n5. Diagnosis of or receiving treatment for another malignancy other than lymphoma, except for the following:\n\n   ①Malignancy that has been treated with curative intent and with no known active disease for ≥ 5 years prior to enrollment;\n\n   ②Adequately treated basal cell carcinoma of the skin (excluding melanoma) with no evidence of disease;\n\n   ③Adequately treated carcinoma in situ of the cervix with no evidence of disease;\n6. Known hypersensitivity to any study drug;\n7. Pregnant or breastfeeding women;\n8. History of stroke or intracranial hemorrhage within 6 months prior to enrollment;\n9. Requirement for anticoagulation therapy with warfarin or equivalent vitamin K antagonists;\n10. Requirement for long-term treatment with strong cytochrome P450 3A (CYP3A) inhibitors;\n11. Receipt of live attenuated vaccine within 4 weeks prior to enrollment.",{"count":213,"type":23},39,[26],"This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.",[217],"Mantle Cell Lymphoma (MCL)",[219,220,221,222],"orelabrutinib","MCL","obinutuzumab","venetoclax","2026-07-21",{"date":225,"type":34},"2026-07-22",{"date":227,"type":23},"2026-07-15",{"date":229,"type":23},"2029-07-01",{"name":40,"class":41},2,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":192,"minAge":19,"maxAge":20,"enrollmentInfo":239,"targetDuration":4,"studyType":24,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":63},"100557890","phase-2-efficacy-and-safety-of-intrathecal-administration-of-thiotepa-in-combination-with-methotrexate-in-breast-cancer-with-leptomeningeal-metastasis-100557890","NCT06543992","Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis","Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate Via the Ommaya Reservoir in Breast Cancer With Leptomeningeal Metastasis: a Phase II Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.\n2. ECGO rating 0-3.\n3. Histologically or cytologically confirmed breast cancer.\n4. A new diagnosis of LM, established either by the presence of malignant cells in the CSF or by the combination of characteristic clinical manifestations and magnetic resonance imaging (MRI) findings\n5. Patients can be implanted or have been implanted with Ommaya reservoirs;\n6. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria);\n7. Postmenopausal or pre\u002Fperimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period.\n8. All patients were required to meet the following laboratory biochemical values prior to enrolment:\n\n   * Haematology: Hb ≥90 g\u002FL, WBC ≥3.5×109\u002FL, ANC ≥1.5×109\u002FL, PLT ≥100×109\u002FL;\n   * Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times the upper limit of normal values, and ≤1.25 x the upper limit of normal values for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of normal value.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ\n2. Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency\n3. The investigator considers the patient unsuitable for entry into this study.\n4. Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0\n5. Patients who have a drug allergy or metabolic disorder to the drugs in this regimen\n6. Pregnant or lactating women (women of childbearing age must have had a negative pregnancy test within 14 days prior to the first dose; if positive, pregnancy must be ruled out by ultrasound).\n7. Patients who are concurrently enrolled in other clinical studies",{"count":240,"type":23},22,[26],"Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis",[244],"Leptomeningeal Metastasis of Breast Cancer",[246,247,248],"methotrexate","thiotepa","intrathecal chemotherapy","2026-07-19",{"date":223,"type":34},{"date":252,"type":34},"2024-08-08",{"date":254,"type":23},"2026-12-13",{"name":40,"class":41},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":263,"targetDuration":4,"studyType":24,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":231},"100648187","phase-2-immunotheray-combined-with-simvastatin-and-target-therapy-and-chemotharepy-for-advanced-colorectal-cancer-100648187","NCT07718490","Immunotheray Combined With Simvastatin and Target Therapy and Chemotharepy for Advanced Colorectal Cancer","A Multicenter, Prospective, Phase II Exploratory Study on the First-line Treatment of MSS\u002F PMMR-type Advanced Colorectal Cancer With Adebrelimab Combined With Simvastatin and Targeted and Chemotherapy","Inclusion Criteria:\n\n1. Able to provide written informed consent and voluntarily participate in this study.\n2. Male or female subjects aged between 18 and 75 years, inclusive.\n3. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.\n4. No prior systemic anti-tumor therapy; patients who have received neoadjuvant\u002Fadjuvant therapy are eligible if the time from the last chemotherapy to recurrence or progression is more than 6 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Expected survival of at least 3 months.\n7. Presence of at least one measurable lesion at baseline assessed by the investigator according to RECIST 1.1. Measurable lesions must not have been previously treated with radiotherapy or other local therapy, unless the lesion located in a previously irradiated area has been confirmed to have progressed.\n8. Adequate organ function as defined below (no blood products or hematopoietic growth factors are allowed within 14 days prior to the first dose of study treatment):\n\n   * Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL\n   * Platelet count ≥100×10\\^9\u002FL\n   * Hemoglobin ≥9 g\u002FdL\n   * Serum albumin ≥2.5 g\u002FdL\n   * Total bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases\n   * Serum creatinine ≤1.5 × ULN, or creatinine clearance \\>60 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n   * Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN. Subjects receiving stable-dose anticoagulation such as low molecular weight heparin or warfarin with INR within the expected therapeutic range are eligible.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment, must not be breastfeeding, and must agree to use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 6 months after the last dose of study treatment. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose of study treatment, and must not donate sperm during the study period.\n\nExclusion Criteria:\n\n1. Received local radiotherapy within 4 weeks prior to the first dose of study drug, and adverse events due to radiotherapy have not recovered to baseline levels. Subjects who received palliative radiotherapy to peripheral sites (e.g., bone metastases) more than 4 weeks prior to the first dose are eligible, provided they have recovered from any acute adverse reactions.\n2. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they have stable brain metastases and have not required steroid treatment for brain metastases for at least 28 days prior to study entry. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability.\n3. Major surgery, open biopsy, or severe trauma within 28 days prior to the first dose of study drug.\n4. History of allergy to any anti-angiogenic agents, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.\n5. Uncontrolled hypertension despite anti-hypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n6. Subjects with uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular or ventricular arrhythmias without clinical intervention or still poorly controlled after clinical intervention.\n7. Significant clinically relevant bleeding symptoms or clear bleeding tendency within 3 months prior to the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis.\n8. Arterial\u002Fvenous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. Superficial venous thrombosis may be included at the investigator's discretion.\n9. Presence of another progressing or actively treated malignancy, except for non-melanoma skin cancer and cervical carcinoma in situ that have received curative treatment.\n10. Subjects with other factors that, in the investigator's opinion, may lead to premature discontinuation of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, clinically significant laboratory abnormalities, family or social factors that may affect subject safety or trial data collection.",{"count":264,"type":23},43,[26],"Metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) molecular phenotypes could significantly benefit from immune checkpoint inhibitor therapy, ushering in the MSI era of immunotherapy for colorectal cancer. However, MSI-H\u002FdMMR is present in only 15%-20% of stage II\u002FIII and 5% of stage IV colorectal cancer patients, while the vast majority of patients exhibit microsatellite stability (MSS) or proficient mismatch repair (pMMR) types, which are insensitive to immunotherapy. Therefore, how to enhance the efficacy of immunotherapy in the pMMR\u002FMSS population through combination therapy has become a hotspot and challenge in colorectal cancer research.",[268],"Metastatic Colorectal Cancer","2026-07-17",{"date":225,"type":34},{"date":272,"type":34},"2025-09-01",{"date":274,"type":23},"2028-03-31",{"name":40,"class":41},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":283,"targetDuration":4,"studyType":24,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":291,"leadSponsor":293,"locationsCount":63},"100648152","phase-2-neoadjuvant-shr-a1811-and-shr-a1701--pertuzumab-for-potentially-immunotherapy-sensitive-gc-or-gej-adenocarcinoma-100648152","NCT07716111","Neoadjuvant SHR-A1811 and SHR-A1701 ± Pertuzumab for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma","A Randomized, Controlled, Exploratory Phase II Study of Trastuzumab Rezetecan in Combination With Retlirafusp Alfa ± Pertuzumab as Neoadjuvant Therapy for Locally Advanced HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma","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":284,"type":23},24,[26],"This is a prospective, single-center, randomized controlled phase II clinical trial.It plans to enroll a total of 24 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). All patients were randomly assigned to the following two groups in a 1:1 ratio.\n\nGroup A:Trastuzumab Rezatecan Dosage: 4.8 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W)\n\nGroup B:\n\nTrastuzumab Rezatecan Dosage: 4.8 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma): 840mg at first usage; subsequent maintenance: 420mg per dose,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\nPreoperative 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 endpoints are efficacy and safety, specifically including:\n\nPrimary Endpoint:\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);\n\nSecondary Endpoints:\n\nMPR 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\nSafety: The incidence rates of adverse events (AE) and serious adverse events (SAE) and their correlation with the treatment.\n\nExploratory Endpoints:\n\nInfiltration status of immune cell subsets in tumor tissue before and after treatment.",[29],"2026-07-16",{"date":223,"type":34},{"date":288,"type":23},{"date":292,"type":23},"2029-08-31",{"name":40,"class":41},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":301,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":302,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":63},"100647608","study-on-the-thrombolytic-effect-of-platelet-membrane-coated-tenecteplase-on-human-arterial-thrombus-100647608","NCT07712445","Study on the Thrombolytic Effect of Platelet Membrane Coated Tenecteplase on Human Arterial Thrombus","Platelet Membrane-coated Tenecteplase to Improve Thrombolytic Efficacy by Targeting Thrombus","Inclusion Criteria:\n\n\\-\n\nFor CAD patients:\n\nAge 18-75 years old, body weight ≥45kg, regardless of gender; Patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy.\n\nTake aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours;\n\nFor healthy volunteer:\n\nAge 18-75 years old, body weight ≥45kg, regardless of gender\n\nExclusion Criteria:\n\nFor CAD patients 1. Previous thrombolytic therapy with TNK; 2. Those who are enrolled in other clinical trials; 3. Those who were deemed ineligible by other investigators.\n\nFor healthy volunteer:\n\n1\\. Currently taking any medication that may affect platelet function, such as antiplatelet drugs or nonsteroidal anti-inflammatory drugs. 2. Individuals with blood disorders, active bleeding or a tendency to bleed, including platelet count \\\u003C100×10\\^9\u002FL, hemoglobin \\\u003C100g\u002FL, or recent bleeding in the digestive system or urinary tract within one month. 3. Individuals with impaired liver or kidney function, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels above the upper limit of normal reference range, and estimated glomerular filtration rate (eGFR) \\\u003C90 mL\u002Fmin\u002F1.73m\\^2 (calculated based on the CKD-EPI equation). 4. Recent (within one month) severe trauma, surgery, or head injury. 5. Pregnant or lactating women. 6. Diabetes. 7. Smokers. 8. Those who are enrolled in other clinical trials; 9. Those who were deemed ineligible by other investigators.",true,{"count":284,"type":23},"OBSERVATIONAL","Tenecteplase (TNK) is the latest generation of specific thrombolytic drugs independently developed in China. This study aims to investigate the thrombolytic efficacy of platelet membrane-coated tenecteplase (PM-TNK) on human ex vivo arterial thrombi, and to explore the inhibitory effects of plasma from patients receiving antiplatelet therapy on its thrombolytic activity, thereby evaluating the future clinical application value of PM-TNK.",[306],"Arterial Thrombosis","2026-07-14",{"date":269,"type":34},{"date":310,"type":34},"2026-06-30",{"date":312,"type":23},"2027-07-30",{"name":40,"class":41},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":301,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":320,"targetDuration":322,"studyType":303,"phases":4,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":330,"leadSponsor":331,"locationsCount":63},"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":321,"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.",[325,326,327],"Hepatic Encephalopathy","Minimal Hepatic Encephalopathy","Liver Cirrhosis",{"date":227,"type":34},{"date":112,"type":23},{"date":274,"type":23},{"name":40,"class":41},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":24,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":63},"100628677","phase-2-shr-1701-with-or-without-apatinib-in-combination-with-chemotherapy-as-neoadjuvant-therapy-for-gastric-cancer-100628677","NCT07464756","SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer","A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study and provide signed informed consent;\n2. Age ≥18 years old;\n3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);\n4. Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable\n5. No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);\n6. Plan to proceed to surgery after completion of neoadjuvant therapy;\n7. Able to swallow tablets normally;\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n9. Estimated life expectancy ≥12 months;\n10. Has adequate organ function.\n11. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.\n\nExclusion Criteria:\n\n1. Known HER2 positive\n2. Need transthoracic surgical approach Based on the investigator's judgment\n3. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;\n\n5\\. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. Congenital or acquired immune deficiency (e.g. HIV infected)",{"count":72,"type":23},[26],"This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.",[343],"Gastric Adenocarcinoma",{"date":288,"type":34},{"date":346,"type":34},"2026-04-03",{"date":348,"type":23},"2030-07-31",{"name":40,"class":41},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":301,"sex":192,"minAge":357,"maxAge":93,"enrollmentInfo":358,"targetDuration":4,"studyType":24,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":63},"100645556","ultrasound-screening-for-early-detection-of-breast-cancer-in-elderly-women-a-mixed-cluster-individual-rct-100645556","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 participants aged 65-80 years.\n* Local residents living in participating communities for ≥6 months.\n* Signed informed consent and willingness to participate.\n\nExclusion Criteria:\n\n* History of breast cancer or previous breast cancer treatment.\n* Breast cancer screening within the past 2 years.\n* Severe comorbid conditions that may affect study participation or follow-up.\n* Acute breast disease or conditions requiring immediate treatment.\n* Unable to cooperate with screening procedures due to physical or cognitive limitations.","65 Years",{"count":359,"type":23},82440,[149],"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.",[363,364],"Breast Neoplasms","Early Detection of Cancer","2026-07-12",{"date":307,"type":34},{"date":368,"type":23},"2026-07-10",{"date":370,"type":23},"2029-12-31",{"name":40,"class":41},{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":301,"sex":18,"minAge":378,"maxAge":4,"enrollmentInfo":379,"targetDuration":381,"studyType":303,"phases":4,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":393,"locationsCount":4},"100647002","early-screening-for-multiple-myeloma-based-on-liquid-biopsy-cfdna-fragmentomics-100647002","NCT07684274","Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics","Inclusion Criteria:\n\n* Age over 40 years.\n* Diagnosed with MM, SMM, or MGUS through standard diagnostic procedures.\n* Voluntarily participating and signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Prior cancer diagnosis within the past 5 years, or history of any form of systemic cancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.).\n* History of organ transplantation, or allogeneic bone marrow or stem cell transplantation.\n* History of blood transfusion within 7 days prior to blood collection.\n* Poor compliance or potential interference with signing informed consent as judged by the investigator, or any other conditions rendering the subject unsuitable for the study.","40 Years",{"count":380,"type":23},290,"5 Years","Study on Early Screening of Myeloma Based on Liquid Biopsy cfDNA Fragmentomics Technology. This study aims to construct and validate a set of machine learning models for the early screening of myeloma tailored to the Chinese population, based on plasma cfDNA fragmentomics features, to effectively distinguish myeloma patients from healthy individuals.",[384,385,386],"Multiple Myeloma (MM)","Smoldering Multiple Myeloma (SMM)","MGUS","2026-07-01",{"date":389,"type":34},"2026-07-06",{"date":391,"type":23},"2026-06-13",{"date":161,"type":23},{"name":40,"class":41},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":4},"100646913","a-biomarker-exploration-study-for-predicting-localization-of-recurrence-and-metastasis-in-colorectal-cancer-probe-study-100646913","NCT07685236","A Biomarker Exploration Study for Predicting Localization of Recurrence and Metastasis in Colorectal Cancer (PROBE Study)","A Multicenter, Observational Clinical Study Evaluating the Application of Multi-Omics Tumor-agnostic Technology for Localizing Postoperative Local Recurrence and Distant Metastasis in Colorectal Cancer","PROBE","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Patients with the following tumor types: primary colorectal cancer, locally recurrent colorectal cancer, colorectal cancer liver metastasis, colorectal cancer lung metastasis, colorectal cancer peritoneal metastasis, colorectal cancer bone metastasis, colorectal cancer multi-organ metastasis, primary liver cancer, primary lung cancer, primary peritoneal cancer, primary bone tumor.\n* No prior surgery or anti-tumor treatment at the time of enrollment assessment.\n* Subjects voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Previous history of malignant tumors other than those within the inclusion criteria.\n* Pregnant or breastfeeding women.","100 Years",{"count":404,"type":23},586,"With high incidence and mortality rate, the effective therapeutic options of colorectal cancer remain limited. Up to 50% of patients with colorectal cancer will develop metastatic disease. Recurrent lesions can be diagnosed and characterized only when tumors have reached a certain volume by present radiologic imaging techniques such as CT and MRI. The exploration of differentiated clinical applications specifically for local recurrence versus distant metastasis remains an unmet need. The aim of this study is to explore methylation, fragmentomic, and cfRNA markers associated with local recurrence and distant metastasis of colorectal cancer by multi-omics approaches. By constructing a predictive model for the localization of post-treatment recurrence and metastasis, this study will compare the accuracy of different technical approaches in predicting the localization of recurrence and metastasis after colorectal cancer treatment.",[407],"Metastatic Colorectal Cancer (CRC)",[268,409],"Locally recurrent colorectal cancer",{"date":389,"type":34},{"date":412,"type":23},"2026-06-29",{"date":414,"type":23},"2027-06-28",{"name":40,"class":41},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":192,"minAge":19,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":434,"leadSponsor":436,"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.",{"count":424,"type":23},100,"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.",[427],"Breast Cancer",[429,430,431],"Multifocal or multicentric breast cancer","Breast-conserving surgery","Local recurrence",{"date":387,"type":34},{"date":227,"type":23},{"date":435,"type":23},"2036-12-30",{"name":40,"class":41},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":301,"sex":18,"minAge":378,"maxAge":93,"enrollmentInfo":445,"targetDuration":4,"studyType":24,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":457,"leadSponsor":458,"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.",{"count":49,"type":23},[149],"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.",[449],"Parkinson Disease",[451,452,453],"Parkinson's disease","depression","taVNS","2026-06-25",{"date":387,"type":34},{"date":387,"type":23},{"date":112,"type":23},{"name":40,"class":41},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":24,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":476,"locationsCount":63},"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":49,"type":23},[74,26],"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).",[471],"MAFLD",{"date":387,"type":34},{"date":474,"type":34},"2026-03-30",{"date":36,"type":23},{"name":40,"class":41},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":484,"targetDuration":4,"studyType":24,"phases":485,"briefSummary":486,"conditions":487,"keywords":489,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":63},"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":284,"type":23},[26],"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.",[488],"CLL (Chronic Lymphocytic Leukemia)",[490,491],"BCL2i","MRD","2026-06-22",{"date":494,"type":34},"2026-06-26",{"date":496,"type":34},"2026-06-01",{"date":498,"type":23},"2030-12-31",{"name":40,"class":41},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":507,"maxAge":20,"enrollmentInfo":508,"targetDuration":4,"studyType":24,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":63},"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",{"count":49,"type":23},[26],"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.",[512],"Gastric Cancer (Diagnosis)",[514],"gastric cancer",{"date":454,"type":34},{"date":387,"type":23},{"date":518,"type":23},"2028-12-30",{"name":40,"class":41},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":537,"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":424,"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.",[427],[531,431,532],"Breast cancer","Prospective cohort study",{"date":454,"type":34},{"date":535,"type":23},"2026-07-20",{"date":435,"type":23},{"name":40,"class":41},{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":544,"targetDuration":4,"studyType":24,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":63},"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":49,"type":23},[26],"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.",[548],"Biliary Tract Neoplasms",{"date":454,"type":34},{"date":551,"type":34},"2025-10-20",{"date":161,"type":23},{"name":40,"class":41},""]