[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Changhai Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":616},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,99,0,25,[9,39,64,93,121,138,164,182,204,232,256,282,304,324,347,369,397,422,445,466,487,512,537,558,587],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100645225","study-on-the-association-between-serrated-polyps-and-metachronous-advanced-colorectal-neoplastic-lesions-100645225",false,"NCT07678788","Study on the Association Between Serrated Polyps and Metachronous Advanced Colorectal Neoplastic Lesions","Risk Factors for Metachronous Advanced Colorectal Lesions After Endoscopic Resection of Serrated Lesions","Inclusion Criteria:\n\n* Adult patients aged \\> 18 years;At least one SP detected during the index colonoscopy and pathologically confirmed as TSA or SSL (according to the 2019 WHO classification criteria);Underwent complete polypectomy during the index colonoscopy;Received regular follow-up at Changhai Hospital, with an interval of ≥ 6 months between the index and follow-up colonoscopies;Complete clinical and pathological data.\n\nExclusion Criteria:\n\n* Incomplete colonoscopy or failed cecal intubation;Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score \\\u003C 6 or a score \\\u003C 2 in any bowel segment;Withdrawal time \\\u003C 6 minutes;Diagnosis of hereditary cancer syndromes, such as familial adenomatous polyposis (FAP) or Lynch syndrome;Concurrent inflammatory bowel disease (IBD) or indeterminate colitis;History of colorectal cancer or other malignancies;Incomplete clinical or pathological records.","ALL","18 Years",{"count":20,"type":21},750,"ESTIMATED","OBSERVATIONAL","This study aims to explore the risk factors associated with the development of ACN and same-site ACN in patients with SP, thereby informing the optimization of clinical surveillance strategies",[25,26],"Sessile Serrated Lesion","Serrated Polyp","NOT_YET_RECRUITING","2026-06-25",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":21},"2026-06-01",{"date":35,"type":21},"2026-12-01",{"name":37,"class":38},"Changhai Hospital","OTHER",{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100552138","early-phase-1-an-exploratory-clinical-study-of-anti-cd19-car-nk-cell-kn5501-in-the-treatment-of-relapsedrefractory-immune-nephropathy-100552138","NCT06469190","An Exploratory Clinical Study of Anti-CD19 CAR NK Cell (KN5501) in the Treatment of Relapsed\u002FRefractory Immune Nephropathy","An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor NK Cell Injections (KN5501) in the Treatment of Relapsed\u002FRefractory Immune Nephropathy","Common Inclusion Criteria:\n\n1. Age: ≥ 18 years old and ≤ 70 years old, male or female;\n2. Positive CD19 expression in peripheral blood B cells as determined by flow cytometry;\n3. The functions of important organs meet the following requirements:\n\n   1. Bone marrow hematopoietic function: a. White blood cell count ≥ 3 x 10\\^9\u002FL b. Neutrophil count ≥ 1 x 10\\^9\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); c. Hemoglobin ≥60g\u002FL.\n   2. Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN(excluding Gilbert syndrome, total bilirubin ≤ 3.0 x ULN)\n   3. Coagulation function: International standardized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) ≤1.5 x ULN.\n   4. Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥55%.\n4. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negative serum HCG test within 7 days prior to study enrollment and are not lactating;\n5. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nCriteria for Recurrent\u002Frefractory primary membranous nephropathy\n\n1. Primary membranous nephropathy diagnosed pathologically by renal biopsy;\n2. Screening period 24-hour urine protein quantification ≥3.5 g;\n3. Individuals who have not achieved partial remission (PR) after more than 6 months of treatment with hormonal and\u002For cytotoxic drugs, immunosuppressive therapy, and\u002For biologics (including but not limited to anti-CD20 monoclonal antibody); or individuals who have relapsed again after achieving complete remission\u002Fpartial remission (CR\u002FPR) with treatment (24h urine protein quantification ≥3.5g);\n4. Glomerular filtration rate (eGFR, CKD-EPI formula) ≥45 ml\u002Fmin\u002F1.73m2 during the screening period.\n\nCriteria for Relapsed\u002Frefractory IgA nephropathy\n\n1. Primary IgA nephropathy pathologically confirmed by renal biopsy;\n2. Treated (ACEI\u002FARB analogs) for at least 3 months;\n3. Treatment with hormonal and\u002For cytotoxic drugs, immunosuppressive therapy, and\u002For biologics (including, but not limited to anti-CD20 monoclonal antibody) for more than 6 months, 24-hour urine protein quantification ≥ 1.0 g; or rapid progression of renal function (≥ 50% decrease in eGFR within 3 months); or relapse after treatment to achieve complete remission\u002Fpartial remission (CR\u002FPR) (24-hour urine protein quantification ≥ 1.0 g);\n4. Glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 ml\u002Fmin\u002F1.73m2 during the screening period.\n\nCriteria for Relapsed\u002Frefractory ANCA-associated vasculitis\n\n1. Meets 2022 ACR\u002FEULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatous polyangiitis, eosinophilic granulomatous polyangiitis;\n2. Positive ANCA related antibodies (MPO-ANCA or PR3-ANCA positive);\n3. Renal biopsy pathology consistent with renal damage in ANCA-associated vasculitis;\n4. The Birmingham Vasculitis Activity Scale (BVAS) is ≥ 15 points (a total score of 63 points), indicating the activity of the vasculitis condition;\n5. BVAS score includes at least 2 abnormalities in the renal program;\n6. Definition of relapse\u002Frefractory : ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: use of glucocorticoids (more than 1 mg\u002Fkg\u002Fd) and cyclophosphamide for ≥3 months, and any of the following immunomodulatory drugs: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents such as rituximab and belimumab;\n7. Glomerular filtration rate (eGFR, CKD-EPI formula) ≥15 ml\u002Fmin\u002F1.73m2 during the screening period.\n\nCommon exclusion Criteria:\n\n1. Individuals with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;\n2. Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;\n3. Individuals with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous system vasculitis);\n4. Individuals with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;\n5. Subjects with congenital immunoglobulin deficiency;\n6. Subjects with malignant tumors (except for non-melanoma skin cancer and in situ cervical, bladder, and breast cancers that have been disease-free for more than 5 years);\n7. Subjects with end-stage renal failure;\n8. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis;\n9. Subjects with mental illness and severe cognitive impairment;\n10. Subjects who have received other clinical trial treatment within 3 months;\n11. Pregnant or intending to conceive women;\n12. In the opinion of the investigator, there are other reasons why subjects cannot be included in this study.\n\nExclusion Criteria for Recurrent\u002Frefractory primary membranous nephropathy\n\n1. Secondary membranous nephropathy (e.g., hepatitis B, systemic lupus erythematosus, drug-associated, malignancy-associated, etc.), or in combination with other renal diseases confirmed by renal biopsy;\n2. Type 1 or type 2 diabetes.\n\nExclusion Criteria for Relapsed\u002Frefractory IgA nephropathy\n\n1. Exclude secondary IgA nephropathy, including but not limited to: anaphylactic purpura, ankylosing spondylitis, systemic lupus erythematosus, desiccation syndrome, viral hepatitis, cirrhosis of the liver, rheumatoid arthritis, and mixed connective tissue disease; or in combination with other renal diseases confirmed by renal biopsy;\n2. Crescentic nephritis (pathologic diagnosis of \\>50% crescentic bodies), micrognathic nephropathy with IgA deposition, and other specific types of pathologic or clinical renal disease.\n\nExclusion Criteria for Relapsed\u002Frefractory ANCA-associated vasculitis\n\n1. Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2;\n2. If the patient has alveolar hemorrhage invasive lung ventilation is required, estimated to last longer than the screening period.","70 Years",{"count":48,"type":21},36,"INTERVENTIONAL",[51],"EARLY_PHASE1","A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cell injection (KN5501) in patients with immune nephropathy. 36 patients are planned to be enrolled in the dose-escalation trial. The primary endpoints are DLT and TEAEs. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR)",[54],"Nephropathy","RECRUITING",{"date":57,"type":31},"2026-06-26",{"date":59,"type":31},"2024-06-21",{"date":61,"type":21},"2027-06-20",{"name":37,"class":38},1,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":74,"studyType":22,"phases":4,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100639693","immune-repertoire-decoding-for-chronic-pancreatitis-to-pancreatic-cancer-risk-stratification-100639693","NCT07612566","Immune Repertoire Decoding for Chronic Pancreatitis-to-Pancreatic Cancer Risk Stratification","Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Able to understand the study procedures and provide written informed consent.\n* Healthy controls: participants without a known history of chronic pancreatitis or pancreatic cancer.\n* Chronic pancreatitis cohort: participants diagnosed with chronic pancreatitis according to clinical guidelines, based on clinical, imaging, and\u002For genetic information.\n* Pancreatic ductal adenocarcinoma cohort: participants with newly diagnosed pancreatic ductal adenocarcinoma based on clinical, imaging, and\u002For pathological evaluation.\n* Willing to provide blood samples and relevant clinical information.\n* For participants with chronic pancreatitis, willing to undergo longitudinal follow-up approximately every 6 to 12 months.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide written informed consent.\n* Unable to provide required clinical information or biological samples.\n* Prior diagnosis of another active malignant tumor, except adequately treated non-melanoma skin cancer or carcinoma in situ, if considered not to affect study participation by the investigator.\n* Current severe acute infection or other serious medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of immune-related analyses.\n* Use of systemic immunosuppressive therapy or immunotherapy within a period considered clinically relevant by the investigator.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.",true,{"count":73,"type":21},800,"30 Months","This study will follow people with chronic pancreatitis, people with pancreatic cancer, and healthy volunteers. The goal is to better understand why some people with chronic pancreatitis may later develop pancreatic cancer.\n\nParticipants will provide blood samples and health information. Some participants may also provide tissue samples if these are available during routine medical care. The study team will look for changes in the immune system, genes, medical images, and clinical information that may be linked to the development of pancreatic cancer.\n\nPeople with chronic pancreatitis will be followed over time. The information collected in this study may help researchers develop a model to identify patients with chronic pancreatitis who have a higher risk of pancreatic cancer.",[77,78],"Chronic Pancreatitis","Pancreatic Cancer",[80,81,82,83,84,85],"Pancreatic Ductal Adenocarcinoma","Immune Repertoire","T-Cell Receptor","B-Cell Receptor","Risk Stratification","Artificial Intelligence","2026-05-21",{"date":88,"type":31},"2026-05-28",{"date":33,"type":21},{"date":91,"type":21},"2028-12-31",{"name":37,"class":38},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":49,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":63},"100637721","impact-of-acetic-acid-indigo-carmine-chromocolonoscopy-on-proximal-sessile-serrated-lesions-100637721","NCT07601217","Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions","Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial","ACID-SSL","Inclusion Criteria:\n\n* Patients whose age are between 45-85\n* Patients who have indications for screening\n* Patients who have signed inform consent form.\n\nExclusion Criteria:\n\n* Patients undergoing surveillance colonoscopy after polypectomy or therapeutic colonoscopy for known polyps\n* Patients with a history of colonoscopy within the past 5 years\n* Patients with highly suspected or confirmed colorectal cancer\n* Patients with alarming signs or symptoms: hematochezia, melena, unexplained anemia, weight loss, abdominal mass, positive digital rectal examination\n* Pregnant or breastfeeding women\n* Patients with gastrointestinal obstruction\n* Patients with inflammatory bowel disease, colonic polyposis, or melanosis coli\n* Patients with coagulation disorders or who have taken antiplatelets or anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy\n* Patients currently participating in another clinical trial or who have participated in another clinical trial within the preceding 60 days\n* Patients with failed cecal intubation for any reason (e.g., obstructing lesion, intolerance of the procedure)\n* Patients with an Aronchick bowel preparation score \\>3 at colonoscope insertion, indicating inadequate preparation requiring a repeat bowel preparation\n* Patients who have used bowel preparation agents not recommended by guidelines, such as oral sodium phosphate or senna\n* Patients with known allergy to acetic acid-indigo carmine, brilliant blue dye, or medications related to colonoscopy\n* Patients with missing essential information in the case report form prior to enrollment","45 Years","85 Years",{"count":104,"type":21},2689,[106],"NA","Chromocolonoscopy with acetic acid and indigo carmine has shown promise for improving the detection of sessile serrated lesions (SSLs), the precursor lesions responsible for a substantial proportion of interval colorectal cancers. Previous studies have demonstrated its potential to enhance visualization of both adenomatous and non-adenomatous polyps, particularly the subtle SSLs that are frequently missed during conventional white-light colonoscopy. However, high-quality randomized controlled trials comparing chromocolonoscopy with standard white-light imaging to provide definitive evidence on its efficacy for SSL detection are lacking. We therefore conducted a multicenter, prospective, randomized controlled trial to evaluate the diagnostic yield of acetic acid-indigo carmine chromocolonoscopy versus standard colonoscopy for SSL detection.",[25],[25,110,111,112],"Sessile Serrated Lesion Detection Rate","Chromocolonoscopy","Acetic Acid and Indigo Carmine","2026-05-17",{"date":115,"type":31},"2026-05-22",{"date":117,"type":21},"2026-06-15",{"date":119,"type":21},"2028-11-15",{"name":37,"class":38},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":71,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":49,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100638679","polyp-pretreatment-device-for-ssl-diagnosis-100638679","NCT07601230","Polyp Pretreatment Device for SSL Diagnosis","Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps","Inclusion Criteria:\n\n1. Patients undergoing colonoscopic polypectomy (≤3 lesions if multiple).\n2. Sessile\u002Fflat polyps (Paris 0-Is,0-IIa, 0-IIb, 0-IIc) resected by snare or EMR with intact specimens.\n3. Signed informed consent.\n\nExclusion Criteria:\n\n1. Refusal or lack of informed consent.\n2. Polyp size ≥25 mm or fragmented resection.\n3. Severe specimen damage\u002Fcautery artifact or time from resection to fixation \\>30 min.\n4. Suspected\u002Fconfirmed CRC, IBD, or polyposis syndromes.\n5. Anticoagulants (aspirin\u002Fwarfarin) within 7 days or coagulation disorders.",{"count":129,"type":21},1156,[106],"Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. A novel polyp pretreatment device mechanically maintains mucosal flatness, ensuring vertical sectioning relative to the muscularis mucosae. This randomized, double-blind, parallel-controlled trial evaluates whether the device improves SSL diagnostic rate and section orientation in sessile colorectal polyps.",[25],{"date":115,"type":31},{"date":117,"type":21},{"date":136,"type":21},"2028-05-01",{"name":37,"class":38},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":71,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":63},"100618752","analysis-of-factors-influencing-the-quality-of-bowel-preparation-before-colonoscopy-in-ibd-patients-100618752","NCT07335705","Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients","Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients: A National Multicenter Prospective Study","Inclusion Criteria:\n\n* Patients aged 18 years or older, of any gender, scheduled for colonoscopy;\n* Patients diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 edition of the Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;\n* Voluntary participation in this study and provision of signed informed consent.\n\nExclusion Criteria:\n\n* History of acute myocardial infarction (within the past 6 months), severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders;\n* Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders;\n* Pregnant or lactating women;\n* Acute intestinal infection within the past 2 weeks;\n* History of colorectal tumors, familial adenomatous polyposis, or Peutz-Jeghers syndrome;\n* History of intestinal obstruction, perforation, stenosis, or any other condition preventing completion of the examination;\n* Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the survey;\n* Individuals already enrolled in this study who schedule a repeat colonoscopy;\n* Currently participating in another clinical observational trial or having participated in any other clinical trial within the past 60 days;\n* Refusal to sign the written informed consent form.","75 Years",{"count":147,"type":21},1000,"The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.",[150,151,152],"IBD (Inflammatory Bowel Disease)","Colonoscopy","Colonoscopy: Bowel Preparation",[154,151,155],"IBD","Bowel preparation","2026-05-12",{"date":158,"type":31},"2026-05-14",{"date":160,"type":31},"2025-12-08",{"date":162,"type":21},"2026-10-01",{"name":37,"class":38},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":171,"targetDuration":4,"studyType":49,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":63},"100620148","pre-packaged-low-residue-diet-for-bowel-preparation-in-patients-with-inflammatory-bowel-disease-100620148","NCT07353853","Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease","Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease: A National Multicenter Randomized Controlled Non-inferiority Clinical Trial","Inclusion Criteria:\n\n* Age: Adult patients between 18 and 75 years old;\n* Diagnosis of IBD according to the 2023 Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;\n* Voluntary participation in this clinical trial and provision of signed informed consent.\n\nExclusion Criteria:\n\n* Patients with acute IBD, severe conditions, combined with major bleeding, suspected toxic megacolon, CD with severe intestinal stricture, gastrointestinal obstruction, or other conditions deemed unsuitable for colonoscopy by the physician;\n* Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction;\n* History of previous colorectal surgical resection or use of medications that may affect intestinal motility within one week (e.g., antidepressants, sedatives, calcium channel blockers);\n* History of stroke, spinal cord injury, or psychiatric disorders that impair compliance with bowel preparation and colonoscopy;\n* Allergy to any component of the administered drugs or meal replacements;\n* Pregnant or lactating women, and other individuals considered unsuitable for bowel preparation and colonoscopy by the physician.",{"count":147,"type":21},[106],"The primary objectives of this project are twofold: firstly, to evaluate the role of Maifu Changqing® Complete Nutrition Formula Powder in bowel preparation for colonoscopy in patients with IBD; and secondly, to enhance the nutritional support and comfort of bowel preparation for IBD patients.",[150,151,152],[154,151,155],{"date":158,"type":31},{"date":178,"type":31},"2026-01-01",{"date":180,"type":21},"2026-06-30",{"name":37,"class":38},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":188,"targetDuration":4,"studyType":49,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100605665","pre-packaged-low-residue-diet-assisting-bowel-preparation-in-patients-with-inflammatory-bowel-disease-100605665","NCT07165470","Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease","Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease：A National Multicenter Randomized Controlled Clinical Trial",{"count":189,"type":21},500,[106],"The primary objectives of this study are as follows:\n\n1.To evaluate the efficacy of Maifu Changqing® Complete Nutritional Formula Powder in bowel preparation for colonoscopy among inflammatory bowel disease (IBD) patients;2.To enhance nutritional status and procedural comfort during bowel preparation in the IBD population.",[152,193],"IBD - Inflammatory Bowel Disease",[195,196,193],"bowel preparation","colonoscopy",{"date":158,"type":31},{"date":199,"type":31},"2025-09-01",{"date":201,"type":21},"2026-12-31",{"name":37,"class":38},2,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":211,"targetDuration":4,"studyType":49,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},"100628649","fmt-for-the-prevention-of-infectious-complications-in-patients-with-moderately-severe-and-severe-acute-pancreatitis-100628649","NCT07464392","FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis","Fecal Microbiota Transplantation for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis: A Multicenter, Randomized, Double-Blind Clinical Trial","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Diagnosed with moderately severe acute pancreatitis (MSAP) or severe acute pancreatitis (SAP) according to the Revised Atlanta Classification 2012, with CT severity index (CTSI) score \\> 4\n* Disease duration of 15 to 21 days\n* Already have a nasojejunal tube in place\n* No absolute contraindications to fecal microbiota transplantation\n* Voluntarily sign the written informed consent form\n\nExclusion Criteria:\n\n* Concurrent severe systemic infection\n* Concurrent extra-intestinal organ infection requiring intervention with broad-spectrum antibiotics\n* Intestinal obstruction, active gastrointestinal bleeding, intestinal perforation, fulminant colitis, or toxic megacolon\n* Unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula\n* Pre-existing chronic organ dysfunction (heart, lung, liver, kidney, or hematologic system) prior to admission\n* Multiple organ dysfunction syndrome (MODS) with a confirmed duration exceeding 2 weeks\n* Active malignancy\n* Autoimmune disease or immunocompromised status (including solid organ or bone marrow transplantation, AIDS, long-term use of immunosuppressants or hormones)\n* Congenital or acquired immunodeficiency\n* Pregnancy or breastfeeding\n* Severe mental disorder",{"count":212,"type":21},150,[106],"The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) works to prevent infections complications in patients in the late phase of moderately severe or severe acute pancreatitis.",[216],"Acute Pancreatitis",[216,218,219,220,221,222],"Moderately Severe Acute Pancreatitis","Severe Acute Pancreatitis","Fecal Microbiota Transplantation","Digestive System Diseases","Pancreatic Diseases","2026-04-10",{"date":225,"type":31},"2026-04-14",{"date":227,"type":31},"2026-04-02",{"date":229,"type":21},"2027-09-30",{"name":37,"class":38},12,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":239,"targetDuration":4,"studyType":49,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100608515","indometacin-with-or-without-aggressive-intravenous-hydration-to-prevent-pancreatitis-after-pancreatic-extracorporeal-shock-wave-lithotripsy-100608515","NCT07202559","Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy","Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial","Inclusion Criteria:\n\n* Patients with painful chronic pancreatitis eligible for P-ESWL treatment\n* Ages between 18-85 years\n* Providing informed consent\n\nExclusion Criteria:\n\n* Patients readmitted to the hospital for ESWL during the study period\n* contraindications to ESWL\n* Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP\\>100pg\u002Fml or Ejection Fraction value\\\u003C50% should be excluded\n* Respiratory insufficiency (pO2 \\\u003C 60 mmHg or saturation \\\u003C 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) \\\u003C70% are excluded\n* Patients receiving more than 1.5 mL\u002Fkg\u002Fh or 3 L\u002F24 h of intravenous fluids in the 24 h before ESWL\n* Hypotension (systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C70 mmHg)\n* Hypo- or hypernatremia (serum Na+ levels \\\u003C 130 or \\> 150 mmol\u002FL)\n* Severe liver disease (cirrhosis with ascites, liver abscess)\n* receiving NSAIDs within 7 days\n* Contraindications for rectal use of NSAIDs (renal dysfunction with serum creatinine \\>120 μmol\u002FL, allergy, active gastrointestinal bleeding, ulcer disease, and NSAID use for other indications \\[other than cardioprotective aspirin\\])\n* presence of coagulopathy or received anticoagulation therapy within 3 days\n* acute pancreatitis within 3 days\n* known active cardiovascular or cerebrovascular disease\n* pregnant or breastfeeding women\n* without a rectum (ie, status post-total proctocolectomy)",{"count":240,"type":21},1250,[106],"This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone.\n\nThe study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin.\n\nThe trial will be conducted at multiple centers, ensuring a broad and diverse patient population.\n\nThe primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure.\n\nThis study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.",[244,245,246],"Pancreatitis, Chronic","Pancreatitis, Acute","Pancreatic Duct Stones","2026-04-08",{"date":249,"type":31},"2026-04-13",{"date":251,"type":31},"2025-10-13",{"date":253,"type":21},"2027-12-01",{"name":37,"class":38},10,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":63},"100631929","comparison-of-the-sensitivity-of-pcle-and-pathological-biopsy-for-gastric-mucosal-lesions-100631929","NCT07507071","Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions","Comparison of the Sensitivity of Probe-Based Confocal Laser Endomicroscopy and Pathological Biopsy for Gastric Mucosal Lesions","pCLE","Inclusion Criteria:\n\n* All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.\n\nExclusion Criteria:\n\n* lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.",{"count":265,"type":21},169,"The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal.\n\nThe probe - based confocal laser endomicroscopy (pCLE) technique enables the real - time display of high-resolution microscopic images of the mucosal layer (with an amplification factor of up to 1000 times) through a slender optical fiber probe that can pass through the standard endoscope's working channel. It is an optical biopsy technique and has unique value in determining the pathological nature of gastric lesions.\n\nAs the Digestive Endoscopy Center of Shanghai Changhai Hospital is a national-level pCLE application demonstration center, it has prospectively collected numerous cases of pCLE examinations of gastric mucosal lesions.\n\nThe main purpose of this study is to retrospectively analyze these cases and compare the sensitivity and specificity of pathological biopsy and pCLE in differentiating the pathological nature of gastric mucosal lesions.",[268],"Early Gastric Cancer",[270,271,272,273,274],"Pathological biopsy","Early gastric cancer","High-grade intraepithelial neoplasia","Probe-based confocal Laser endomicroscopy","Endoscopic submucosal dissection","2026-03-29",{"date":227,"type":31},{"date":278,"type":21},"2026-03-30",{"date":280,"type":21},"2026-04-15",{"name":37,"class":38},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":289,"targetDuration":4,"studyType":49,"phases":291,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100630617","phase-2-neoadjuvant-therapy-with-iparomlimab-and-tuvonralimab-lenvatinib-and-chemotherapy-in-resectable-escc-100630617","NCT07490002","Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCC","A Phase II Clinical Study of Neoadjuvant Therapy With Epacadostat, Lenvatinib, and Chemotherapy in Surgically Resectable Esophageal Cancer","Inclusion Criteria:\n\n* Gender: no restriction; Age: 18-75 years.\n* Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.\n* Clinical stage II-IVa (T2-4aN+M0) according to the AJCC 8th edition, and assessed as resectable by a multidisciplinary team (MDT).\n* Complete imaging work-up shows no evidence of distant metastasis:\n\n  1. Neck ultrasound and contrast-enhanced chest\u002Fabdominal CT.\n  2. Ultrasound-guided lymph node biopsy or PET\u002FCT if clinical suspicion or neck ultrasound suggests cervical lymph node metastasis.\n  3. Abdominal non-contrast and contrast-enhanced MRI or PET\u002FCT to confirm diagnosis if CT suggests liver metastasis.\n  4. Bone scan if necessary in case of systemic bone pain symptoms.\n  5. Endoscopic ultrasound for accurate staging.\n* No prior antitumor therapy received (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine).\n* ECOG Performance Status score: 0-1.\n* Adequate organ function, meeting the following laboratory criteria (no blood transfusion, granulocyte colony-stimulating factor \\[G-CSF\\], or corrective medication within 14 days prior to treatment):\n\n  1）Hemoglobin (Hb) ≥90 g\u002FL. 2）Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL. 3）Platelet count (PLT) ≥100×10⁹\u002FL. 4）Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN). 5）Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN. 6）Serum creatinine clearance (CrCl) ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula). 7）Coagulation: International normalized ratio (INR) ≤1.5 × ULN, activated partial thromboplastin time (APTT) ≤1.5 × ULN. 8）Proteinuria \\\u003C 2+ (if ≥ 2+, a 24-hour urine protein quantification must be performed; patients are eligible if the result is ≤1 g). 9）Left ventricular ejection fraction (LVEF) ≥50%.\n* No surgical contraindications.\n* The subject agrees to use effective contraception from the signing of the informed consent form until 180 days after the last dose. Female subjects of childbearing potential must not be pregnant or breastfeeding.\n* Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Known history of hypersensitivity to macromolecular protein preparations. Contraindications or allergies to any component of epaplimut-pembrolizumab.\n* Other anti-tumor therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, chemoembolization, anti-tumor traditional Chinese herbal medicine).\n* Radiographic diagnosis indicating distant metastasis of the tumor.\n* History of allogeneic tissue\u002Fsolid organ transplantation.\n* Within 2 weeks prior to the first dose, presence of a condition requiring systemic corticosteroid (\\>10 mg daily prednisone or equivalent) or other immunosuppressive medication (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.). Topical, nasal spray, and inhaled corticosteroids are permitted. Prophylactic use of systemic corticosteroids for contrast agent allergy is allowed.\n* Active or potentially recurrent autoimmune diseases, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes requiring only stable-dose insulin replacement therapy.\n* Other active malignancies within the past 5 years, except for cured localized cancers (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast) and breast cancer without recurrence for more than 3 years after radical surgery.\n* History of interstitial lung disease and\u002For pneumonitis or pulmonary hypertension.\n* Poorly controlled ascites, pericardial effusion, or pleural effusion requiring repeated drainage.\n* Poorly controlled hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg) and diabetes despite standard treatment, or uncontrolled or symptomatic arrhythmia.\n* Thromboembolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or pulmonary embolism.\n* Myocardial infarction within the past 12 months, severe\u002Funstable angina, or symptomatic congestive heart failure (NYHA class III or IV).\n* Participation in other clinical trials within 60 days prior to or during the treatment period.\n* Known active infection with HIV, HBV, or HCV.\n* Major surgery (excluding needle biopsy) within 4 weeks prior to the first dose without full recovery.\n* Any other condition deemed by the investigator as inappropriate for inclusion in this study.",{"count":290,"type":21},33,[292],"PHASE2","This is a single-arm, exploratory clinical study.",[295],"Esophageal Squamous Carcinoma","2026-03-19",{"date":298,"type":31},"2026-03-24",{"date":300,"type":21},"2026-04-06",{"date":302,"type":21},"2030-11-30",{"name":37,"class":38},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":49,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":63},"100630824","phase-2-efficacy-and-safety-of-hetrombopag-in-preventing-chemotherapy-induced-thrombocytopenia-in-gastrointestinal-tumors-100630824","NCT07492693","Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors","Exploring the Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors","Inclusion Criteria:\n\n1. age ≥18 years;\n2. pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);\n3. during the previous chemotherapy cycle (N-1 cycle), patients had a minimum platelet count of ≥75×10⁹\u002FL and at least one high-risk bleeding factor (① history of bleeding; ② previous treatment with platinum agents, gemcitabine, cytarabine, anthracyclines, etc.; ③ tumor cell bone marrow infiltration; ④ previous or ongoing radiotherapy, especially to long bones or flat bones such as the pelvis or sternum);\n4. during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹\u002FL;\n5. undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.\n6. ECOG score: 0-2 points;\n7. Adequate hematopoietic, liver, and kidney function:\n\n   * Neutrophil count ≥ 1.5 x 10⁹\u002FL\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)\n   * For patients without liver metastasis, AST and ALT ≤ 2.5 times the upper limit of normal;\n   * Bilirubin ≤ 2 times the upper limit of normal;\n   * APTT and PT ≤ 1.5 times the upper limit of normal\n8. Signed informed consent form.\n\nExclusion Criteria\n\n1. Previous use of TPO-RA drugs;\n2. Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;\n3. History of thrombosis;\n4. Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);\n5. Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);\n6. Pregnant or breastfeeding women;\n7. Participation in other drug clinical trials within 4 weeks;\n8. Poor compliance, unable to cooperate or report treatment responses;\n9. Need for other antiplatelet or platelet-enhancing drugs, including traditional Chinese medicine and herbal preparations;\n10. Use of prior platelet-stimulating drugs within 5 half-lives before first dose;\n11. Platelet transfusion within 3 days before first dose.",{"count":312,"type":21},40,[292],"This trial is a single-arm, prospective clinical study aimed at evaluating the efficacy and safety of hetrombopag in preventing chemotherapy-induced thrombocytopenia (CIT) in patients with gastrointestinal tumors. The study plans to enroll 40 patients with gastrointestinal tumors who develop thrombocytopenia due to chemotherapy. Patients who meet the inclusion and exclusion criteria will maintain the same treatment regimen and dosage as the previous cycle (N-1 cycle). On the day of chemotherapy in the current cycle (N cycle), they will take hetrombopag (D1) at 7.5 mg\u002Fday orally for 14 consecutive days on an empty stomach, and may eat two hours after administration, avoiding taking it with meals.",[316],"Chemotherapy-induced Thrombocytopenia (CIT) in Patients With Gastrointestinal Tumors",{"date":318,"type":31},"2026-03-25",{"date":320,"type":31},"2024-10-01",{"date":322,"type":21},"2026-08-01",{"name":37,"class":38},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":4},"100629970","capsule-endoscopy-in-gi-bleeding-a-retrospective-study-100629970","NCT07481591","Capsule Endoscopy in GI Bleeding: A Retrospective Study","Retrospective Analysis of the Diagnostic Value of Capsule Endoscopy in Patients With Gastrointestinal Bleeding","Inclusion Criteria:\n\n* Age ≥18 years old;\n* Obvious symptoms of gastrointestinal bleeding (such as hematemesis, melena, hematochezia, and positive fecal occult blood test);\n* From January 2021 to December 2025, magnetic capsule endoscopy was performed at Chang Hai Hospital\n\nExclusion Criteria:\n\n* Known or suspected intestinal obstruction, stenosis, or fistula;\n* Severe asthma, swallowing disorders, or gastroparesis and other motility disorders;\n* History of abdominal surgery that has affected the normal structure of the digestive tract in the past;\n* When capsule retention occurs, the problem cannot be solved through surgical means due to subjective or objective reasons;\n* Implantable medical devices such as pacemakers, cochlear implants, drug infusion pumps, and nerve stimulators are installed inside the body, except for MRI compatible products;\n* Pregnant women;\n* Patients who need to undergo MRI examination before capsule endoscopy is discharged;\n* Suffering from severe heart and lung diseases (severe myocardial infarction, arrhythmia, heart failure, respiratory failure, etc.);\n* Refusing capsule endoscopy or gastroscopy examination;\n* Researchers believe that there are any other influencing factors that are not suitable for participants to participate in the study",{"count":332,"type":21},350,"The goal of this observational study is to evaluate the diagnostic value and safety of capsule endoscopy in patients with gastrointestinal bleeding. The main questions it aims to answer are:\n\nWhat is the overall detection rate of bleeding lesions using capsule endoscopy? What is the completion rate of capsule endoscopy, and how long does it take for the capsule to pass through the stomach and small intestine? What adverse events (such as capsule retention) occur during or after the procedure?\n\nParticipants who underwent capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025 will:\n\nHave their existing medical records (including endoscopy reports, procedure notes, and follow-up records) reviewed by researchers Have their personal information anonymized and protected Not be required to undergo any additional tests, procedures, or visits This is a retrospective study that only analyzes previously collected data. No new interventions or patient contact is involved.",[335],"Gastrointestinal Bleeding",[337,338,339],"gastrointestinal bleeding","retrospective study","capsule endoscopy","2026-03-16",{"date":296,"type":31},{"date":343,"type":21},"2026-03-15",{"date":345,"type":21},"2026-05-15",{"name":37,"class":38},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":354,"conditions":355,"keywords":359,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":366,"leadSponsor":368,"locationsCount":63},"100628485","establishment-of-image-database-for-early-upper-gastrointestinal-cancer-precancerous-lesions-and-precancerous-conditions-100628485","NCT07462247","Establishment of Image Database for Early Upper Gastrointestinal Cancer, Precancerous Lesions, and Precancerous Conditions","Inclusion Criteria:\n\n1. Male or female participants aged ≥ 18 years\n2. Patients with early upper gastrointestinal cancer referred for endoscopic submucosal dissection (ESD), or patients with upper gastrointestinal precancerous lesions or precancerous conditions referred for biopsy by esophagogastroduodenoscopy (EGD)\n3. Participants who are willing and able to participate in this study, complete all required examinations and follow-up visits, and who have provided written informed consent\n\nExclusion Criteria:\n\n1. Patients who are not eligible for surgery or who refuse any abdominal surgery in case of capsule retention and endoscopic retrieval failure\n2. Patients with cardiac pacemaker or other implanted electromedical devices which could interfere with magnetic resonance\n3. Suspected or known intestinal stenosis or other known risk factors for capsule retention\n4. Patients with dysphagia\n5. Pregnancy\n6. Allergy to polymeric materials, latex, simethicone, or pronase\n7. Patients plan to undergo magnetic resonance imaging examination before excretion of the capsule\n8. Patients with any condition that precludes compliance with the study",{"count":189,"type":21},"The study is designed to collect magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, CT images, and histopathology results to establish a database for early upper gastrointestinal cancer, precancerous lesions, and precancerous conditions.",[356,357,358],"Upper Gastrointestinal Cancer","Upper Gastrointestinal Precancerous Lesions","Upper Gastrointestinal Precancerous Conditions",[360,361],"image database","upper gastrointestinal cancer","2026-03-11",{"date":364,"type":31},"2026-03-12",{"date":362,"type":31},{"date":367,"type":21},"2030-12",{"name":37,"class":38},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":376,"enrollmentInfo":377,"targetDuration":379,"studyType":22,"phases":4,"briefSummary":380,"conditions":381,"keywords":387,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":63},"100626755","ai-powered-precision-decision-making-for-pancreatic-diseases-100626755","NCT07439757","AI-Powered Precision Decision-Making for Pancreatic Diseases","A Multicenter Clinical Study on AI-Powered Precision Decision-Making Management for Pancreatic Diseases Using Contrast-Enhanced CT","Inclusion Criteria:\n\n* Clinically suspected pancreatic disease.\n* Scheduled to undergo contrast-enhanced CT.\n* Signed informed consent form indicating agreement to participate.\n\nExclusion Criteria:\n\n* History of pancreatic surgery.\n* Contraindications to contrast-enhanced CT, including known hypersensitivity to iodinated contrast media or severe renal\u002Fhepatic dysfunction.\n* Suboptimal image quality affecting diagnosis.\n* Concurrent participation in another interventional clinical trial.\n* Unsuitability for participation as determined by the investigator, including but not limited to: pregnancy or lactation, severe psychiatric disorders or cognitive impairment, significant comorbidities that may interfere with study results or patient safety.","80 Years",{"count":378,"type":21},2000,"1 Year","This multicenter clinical trial evaluates an artificial intelligence (AI) system designed to assist in the diagnosis and management of pancreatic diseases. Using contrast-enhanced CT scans, the study compares the AI's recommendations against the decisions of experienced clinicians to verify the system's accuracy and safety in a real-world setting. Patients are categorized into three management groups: Intervention (surgery\u002Ftreatment), Intensive Surveillance (close monitoring), or Routine Surveillance (standard follow-up). The primary goal is to determine if the AI system can reliably classify patients, reduce the risk of missing malignant lesions, and prevent unnecessary surgeries, thereby improving clinical decision-making for pancreatic conditions.",[78,382,383,384,77,385,386],"Diagnose Disease","IPMN, Pancreatic","Pancreatic Cystic Lesions","Pancreatic Neuroendocrine Tumor","Acute Pancreatitis (AP)",[388],"Artificial Intelligence (AI), Deep Learning, Contrast-Enhanced CT, Multicenter Clinical Trial, Real-World Study","2026-02-23",{"date":391,"type":31},"2026-02-27",{"date":393,"type":21},"2026-03-01",{"date":395,"type":21},"2029-10-31",{"name":37,"class":38},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":404,"targetDuration":4,"studyType":49,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":63},"100611862","early-phase-1-exploratory-clinical-study-on-the-safety-and-efficacy-of-anti--cd19bcma-u-car-t-cell-injection-for-the-treatment-of-relapsedrefractory-autoimmune-diseases-100611862","NCT07246096","Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19\u002FBCMA U CAR-T Cell Injection for the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19\u002FBCMA Universal CAR-T Cell Injection for the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Common inclusion criteria:\n\n1. Age: ≥ 18 years old and ≤ 70 years old, male or female;\n2. The functions of critical organs meet the following requirements:\n\na )Neutrophil count ≥ 1 x 10\\^9\u002FL, Hemoglobin ≥60g\u002FL; b) Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN; c) Coagulation function: International standardized ratio (INR) ≤1.5x ULN, prothrombin time (PT) ≤1.5 x ULN; d) Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥50%; 3. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negativeserum HCG test within 7 days prior to study enrollment and are not lactating; 4. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nSpecific inclusion criteria:\n\nRelapsed\u002FRefractory Systemic lupus erythematosus\n\n1. Subject have previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American College of Rheumatology revised SLE classification criteria, the 2012 Systemic Lupus International Collaborating Clinics classification criteria, or the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology joint classification criteria);\n2. Subjects had a modified SLEDAI-2K score of ≥8 at screening;\n3. Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score at screening;\n4. Based on the results of the central laboratory tests at screening, the subject meets one of the following: a. ANA by immunofluorescence ≥ 1:80 b. Anti-dsDNA antibodies above the normal level c. Anti-Smith antibodies above the normal level.\n\nRelapsed\u002FRefractory Systemic Sclerosis\n\n1. Meets 2013 ACR classification criteria for systemic sclerosis;\n2. If combined with interstitial pneumonia, interstitial changes suggestive of ground-glass exudates on chest HRCT and FVC or DLCO \\\u003C70% predictive value on pulmonary function tests;\n3. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (above 1mg\u002FKg\u002Fd) and cyclophosphamide, as well as any of the following immunomodulatory drugs for more than 6 months: antimalarials,\n4. methotrexate, leflunomide, cyclophosphamide, azathioprine, mertiomate, tacrolimus, cyclosporine, and biologics, including rituximab, belimumab and tetracycline;\n5. Definition of progressiveness; 1) Definition of cutaneous progression: increase in mRSS \\>10%; 2) Definition of lung disease progression: 10% decrease in FVC or 5% decrease in FVC with 15% decrease in DLCO (OMERACT progression).\n\nRelapsed\u002FRefractory Primary Sjögren's Syndrome\n\n1. Meets 2002 AECG criteria or 2016 ACR\u002FEULAR classification criteria for primary dry syndrome (pSS);\n2. Definition of disease activity: investigator-assessed disease ESSDAI score of 5 or higher;\n3. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (above 1mg\u002FKg\u002Fd) and cyclophosphamide, as well as any of the following immunomodulatory drugs for more than 6 months: antimalarials, methotrexate, leflunomide, cyclophosphamide, azathioprine, mertiomate, tacrolimus, cyclosporine, and biologics, including rituximab, belimumab and tetracycline.\n\nRelapsed\u002FRefractory rheumatoid arthritis\n\n1. Meets the diagnostic criteria of the 2010 ACR\u002FEULAR classification. Diagnosis of moderately or severely active rheumatoid arthritis with a previous diagnosis of rheumatoid arthritis ≥ 6 months;\n2. A swollen joint count of ≥ 6 (based on 66 joint counts) and a tender joint count of ≥ 6 (based on 68 joint counts) during the Screening Period;\n3. C-reactive protein (CRP) ≥ 10 mg\u002FL or erythrocyte sedimentation rate (ESR) ≥ 28 mm\u002Fh during the Screening Period;\n4. EULAR definition of refractory rheumatoid arthritis:\n\n1） Failure of treatment according to EULAR recommended guidelines and failure of treatment with ≥2 b\u002FtsDMARDs despite failure of treatment with csDMARDs. (i) unless treatment with bDMARDs\u002FtsDMARDs is limited due to socioeconomic factors; and (ii) if treatment with csDMARDs is contraindicated, then failure of treatment with ≥2 b\u002FtsDMARDs of different mechanisms also fulfills the condition); 2） Symptom management of RA is considered problematic by both the patient and the physician; 3） Signs suggestive of active or progressive disease if at least 1 of the following 5 items is met (Meeting all three of the below criteria can be diagnosed as rheumatoid arthritis): i. At least moderate disease activity (DAS28-ESR \\>3.2 or CDAI\\>10); ii. Signs and\u002For symptoms suggestive of active disease; iii. Inability to reduce glucocorticoids to less than 7.5 mg\u002Fdayprednisone or equivalent; iv. Rapid imaging progression (1-year increase of ≥5 points in vander Heijde modified Sharp score); v. Decreased quality of life due to RA, although RA is well controlled.\n\nRelapsed\u002Frefractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis\n\n1. Meets 2022 ACR\u002FEULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatous polyangiitis, eosinophilic granulomatous polyangiitis;\n2. Positive ANCA related antibodies (MPO-ANCA or PR3-ANCA positive);\n3. The Birmingham Vasculitis Activity Scale (BVAS) is ≥ 15 points (a total score of 63 points), indicating the activity of the vasculitis condition;\n4. Glomerular filtration rate (eGFR, CKD-EPI formula) ≥15 ml\u002Fmin\u002F1.73 m2 during the screening period.\n\nExclusion Criteria:\n\nSubjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study.\n\nCommon exclusion Criteria:\n\n1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;\n2. Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;\n3. Subjects with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous system vasculitis);\n4. Subjects s with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;\n5. Subjects with congenital immunoglobulin deficiency;\n6. Subjects with malignant tumors (except for non-melanoma skin cancer and in situ cervical, bladder, and breast cancers that have been disease free for more than 5 years);\n7. Subjects with end-stage renal failure;\n8. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis,B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis;\n9. Subjects with mental illness and severe cognitive impairment;\n10. Subjects who have received other clinical trial treatment within 6 months;\n11. Pregnant or intending to conceive women;\n12. Subjects with hypertension or diabetes that cannot be controlled by medication;\n13. In the opinion of the investigator, there are other reasons that prevent some subjects from being included in this study.\n\nSpecific exclusion Criteria:\n\nRelapsed\u002FRefractory Systemic lupus erythematosus\n\n1. Except for SLE, any clinically significant history of cardiac, endocrine, blood, liver, immune, metabolic, urinary, pulmonary, neurological, skin, psychiatric, or renal disorders, or other major diseases that may interfere with the administration of KN3601 (as determined by the investigator);\n2. Except for SLE, any active skin disease that could interfere with the research evaluation of SLE including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous lupus manifestations (such as cutaneous vasculopathy, periungual capillary dilation, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus.\n\nRelapsed\u002FRefractory Primary Sjögren's Syndrome\n\n1\\. SSc-like disease caused by environmental, ingestion, or injection factors, accompanied by other autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, etc.).\n\nRelapsed\u002FRefractory dry syndrome\n\n1. Combined cirrhosis of the liver;\n2. Combination of aplastic anemia (AA), myelodysplastic syndrome (MDS), or other myeloproliferative disease (MPD).\n\nRelapsed\u002FRefractory rheumatoid arthritis\n\n1\\. Functional status of rheumatoid arthritis graded at level 4 according to ACR.\n\nRelapsed\u002Frefractory ANCA-associated vasculitis\n\n1. Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2;\n2. If the patient has alveolar hemorrhage invasive lung ventilation is required, estimated to last longer than the screening period.",{"count":405,"type":21},60,[51],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19\u002FBCMA U CAR T cells in patients with autoimmune diseases.\n\n60 patients are planned to be enrolled in the dose-escalation trial.",[409,410,411,412,413,414],"Autoimmune Diseases","Systemic Lupus Erythematosus","Systemic Sclerosis","Primary Sjögren Syndrome","Rheumatoid Arthritis","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis",{"date":416,"type":31},"2026-02-25",{"date":418,"type":21},"2026-02-20",{"date":420,"type":21},"2028-07-20",{"name":37,"class":38},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":429,"targetDuration":4,"studyType":49,"phases":431,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":63},"100625657","phase-1-car-nk-cells-cl-nk-003-in-pancreatic-cancer-100625657","NCT07425483","CAR-NK Cells (CL-NK-003) in Pancreatic Cancer","A Clinical Study of CAR-NK Cells (CL-NK-003) in Patients With Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* 1\\. Aged 18-75 years;2. Locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of eGR1 (membrane positive tumor cell rate \\>40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment;3. At least 1 measurable lesion according to RECIST 1.1;4. Have not received anti-tumor treatment for at least 4 weeks;5. ECOG performance status of 0-2;6. Estimated life expectancy more than 12 weeks;7. Hematology: neutrophils ≥ 1.5×10\\^9\u002FL, lymphocytes ≥ 0.8×10\\^9\u002FL, hemoglobin ≥ 100 g\u002FL, and platelets ≥ 75 × 10\\^9\u002FL;8. Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula);9. Volunteer to participate in this clinical study and willing to sign written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Evidence of central nervous system involvement;2. Have received adoptive cell therapy;3. Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;4. Vaccinated with a live attenuated vaccine within 3 months;5. History of immunodeficiency;6. Active autoimmune disease;7. Regular use of systemic corticosteroids within 2 weeks prior to screening at a dose exceeding prednisone 10 mg\u002Fday (or equivalent) on any day; 8. Have severe conditions, including but not limited to: (1) severe respiratory diseases; (2) severe cardiovascular diseases (previous history of CABG\u002FPCI; myocardial infarction\u002Funstable angina pectoris, congestive heart failure of NYHA III-IV, left ventricular ejection fraction \\\u003C 50%, or poorly controlled hypertension within 6 months; QTc interval \\> 480ms, long or short QT syndrome; previous history of ventrical arrhythmia, or ventrical arrhythmia under anti-arrhythmic drugs\u002FICD); (3) poorly controlled diabetes and other metabolic diseases; (4) severe gastrointestinal diseases (severe gastrointestinal bleeding, severe diarrhea of CTCAE ≥ 2, or severe gastrointestinal obstruction needing intervention);9. Possible severe adverse events, allergy or other contraindications to drugs or its component under study;10. Pregnant or lactating women;11. History of neurological or psychological disorders;12. Not suitable to participate this clinical study judged by the investigator.",{"count":430,"type":21},9,[432],"PHASE1","This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.",[78],[436,437],"pancreatic cancer","CAR-NK","2026-02-13",{"date":389,"type":31},{"date":441,"type":31},"2026-02-12",{"date":443,"type":21},"2028-12",{"name":37,"class":38},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":452,"targetDuration":4,"studyType":49,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":63},"100611506","early-phase-1-an-exploratory-clinical-study-on-the-safety-and-efficacy-of-anti-cd19bcma-u-car-t-cells-in-the-treatment-of-relapsedrefractory-immune-mediated-kidney-disease-100611506","NCT07241468","An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19\u002FBCMA U CAR-T Cells in the Treatment of Relapsed\u002FRefractory Immune-mediated Kidney Disease","An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19\u002FBCMA Universal Chimeric Antigen Receptor T Cells in the Treatment of Relapsed\u002FRefractory Immune-mediated Kidney Disease","Inclusion Criteria:\n\n1. Age: ≥ 18 years old and ≤ 70 years old, male or female;\n2. 2 B cell CD19 positive expression in peripheral blood detected by flow cytometry;\n3. The functions of critical organs meet the following requirements:\n\n   1. Neutrophil count ≥ 1 x 10\\^9\u002FL, Hemoglobin ≥60g\u002FL, platelets ≥ 50×109\u002FL,\n   2. Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN,\n   3. Coagulation function: International standardized ratio (INR) ≤ 1.5x ULN, prothrombin time (PT) ≤1.5 x ULN,\n   4. Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥55%.\n4. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negative serum HCG test within 7 days prior to study enrollment and are not lactating;\n5. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\n   Specific inclusion criteria:\n\n   High-risk or relapsed\u002Frefractory primary membranous nephropathy\n6. Primary membranous nephropathy diagnosed pathologically by renal biopsy;\n7. Meets the clinical criteria for high-risk or recurrent\u002Frefractory membranous nephropathy, defined as:\n\n   Subjects at risk who meet any of the following criteria: a) estimated glomerular filtration rate (eGFR, CKD-EPI equation) \\\u003C60 mL\u002Fmin\u002F1.73m², and\u002For urine protein \\>8g\u002Fday persisting for more than 6 months;b) normal GFR, urinary protein \\>3.5 g\u002Fd, treated with ACEI\u002FARB for 6 months, urinary protein reduction \\\u003C50%, and serum albumin \\\u003C25 g\u002Fl or aPLA2R \\>50 RU\u002FmL;\n\n   Refractory membranous nephropathy subjects are defined as those who have shown poor response or resistance to previous immunosuppressive treatments (including corticosteroids and\u002For cytotoxic drugs, immunosuppressants and\u002For biologics), defined as persistent proteinuria ≥3.5g\u002Fday with a reduction of \\\u003C50% compared to baseline;\n\n   Recurrent membranous nephropathy is defined as a relapse (24-hour urinary protein ≥3.5 g) in subjects who have achieved complete or partial remission following treatment;\n8. Subjects with relapsed\u002Frefractory MN and eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2 during the screening period;\n9. Primary IgA nephropathy pathologically confirmed by renal biopsy;\n10. Subjects have medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening;\n11. Subjects have been treated with hormones and\u002For cytotoxic drugs, immunosuppressants and\u002For biological agents (including but not limited to anti-CD20 monoclonal antibodies) for more than 6 months, and the 24-hour urine protein is ≥1.0 g; subjects with a rapidly progressive decline in kidney function (eGFR decreases by ≥50% within 3 months); or The subject relapsed after achieving complete remission\u002Fpartial remission (CR\u002FPR) following treatment (24-hour urine protein ≥1.0 g);\n12. Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL\u002Fmin\u002F1.73m2 at screening;\n13. Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis;\n14. ANCA-related antibodies positive (MPO-ANCA or PR3-ANCA positive);\n15. Kidney biopsy pathology is consistent with ANCA-associated vasculitis renal damage;\n16. Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis;\n17. At least two abnormalities related to the kidneys in the BVAS score;\n18. Subjects meeting the definition of relapsed\u002Frefractory: standard treatment is ineffective or disease activity recurs after remission. Definition of conventional treatment: using glucocorticoids (more than 1mg\u002Fkg\u002Fday) and cyclophosphamide, along with any one of the following immunomodulatory drugs for ≥3 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and thalidomide;\n19. Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL\u002Fmin\u002F1.73m2 at screening\n\nExclusion Criteria:\n\nSubjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study\n\nCommon exclusion Criteria:\n\n1. Subjects known to have allergic reactions, hypersensitivity, intolerance, or contraindications to CD19\u002FBCMA universal CAR-T or any drug components that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or who have previously experienced severe allergic reactions;\n2. The subject has or is suspected of having uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system disorders caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, central nervous system vasculitis);\n4. Subjects with more serious heart conditions, such as angina, myocardial infarction, heart failure, and arrhythmias;\n5. Subjects with congenital immunoglobulin deficiency;\n6. The subject has other malignant tumours (excluding non-melanoma skin cancer and carcinoma in situ of the cervix, bladder cancer, and breast cancer with disease-free survival of over 5 years);\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have peripheral blood HBV DNA titres above the detection limit; subjects who are positive for hepatitis C virus (HCV) antibodies and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibodies; subjects who test positive for syphilis;\n9. Subjects have mental illness and severe cognitive impairment;\n10. Subjects who have participated in other clinical trials within 6 months prior to enrolment;\n11. Female participants who are pregnant or planning to conceive;\n12. Subjects with hypertension and diabetes uncontrolled by medication;\n13. Researchers believe that there are other reasons why some subjects cannot be included in this study;\n\n    Specific exclusion Criteria:\n\n    Relapsed\u002FRefractory Primary Membranous Nephropathy\n14. Secondary membranous nephropathy (e.g., hepatitis B, systemic lupus erythematosus, drug-associated, malignancy-associated, etc.), or in combination with other renal diseases confirmed by renal biopsy;\n\n    Relapsed\u002FRefractory IgA Nephropathy\n15. Exclude secondary IgA nephropathy, including but not limited to: anaphylactic purpura, ankylosing spondylitis, systemic lupus erythematosus, desiccation syndrome, viral hepatitis, cirrhosis of the liver, rheumatoid arthritis, and mixed connective tissue disease; or in combination with other renal diseases confirmed by renal biopsy;\n16. Crescentic nephritis (pathologic diagnosis of \\>50% crescentic bodies), micrognathic nephropathy with IgA deposition, and other specific types of pathologic or clinical renal disease;\n\n    Relapsed\u002Frefractory ANCA-associated vasculitis kidney damage\n17. Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2;\n18. If subjects have alveolar haemorrhage and requires invasive lung ventilation, the expected duration exceeds the screening time.",{"count":48,"type":21},[51],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19\u002FBCMA U CAR T cell injection (KN3601) in patients with Relapsed\u002FRefractory immune-mediated kidney disease",[456,457],"Relapsed\u002FRefractory Immune Nephropathy","Relapsed\u002FRefractory Immune-mediated Kidney Disease","2026-02-05",{"date":460,"type":31},"2026-02-06",{"date":462,"type":31},"2025-11-15",{"date":464,"type":21},"2027-12-30",{"name":37,"class":38},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":473,"targetDuration":4,"studyType":49,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":63},"100615898","early-phase-1-an-exploratory-clinical-study-on-the-safety-and-efficacy-of-cd19bcma-car-nk-in-the-treatment-of-relapsed-and-refractory-igg4-related-disease-100615898","NCT07298590","An Exploratory Clinical Study on the Safety and Efficacy of CD19\u002FBCMA CAR-NK in the Treatment of Relapsed and Refractory IgG4-related Disease","An Exploratory Clinical Study on the Safety and Efficacy of CD19\u002FBCMA CAR-NK (KN5601) in the Treatment of Relapsed and Refractory IgG4-related Disease (IgG4-RD)","Inclusion Criteria:\n\n1. Subjects must be able to understand and provide informed consent and be willing to comply with study procedures and follow-up.\n2. The age at the time of signing the informed consent must be at least 18 years old and no more than 70 years old.\n3. Meet the 2020 Japanese criteria or ACR\u002FEULAR IgG4-RD classification criteria.\n4. Subjects with relapsed\u002Frefractory active IgG4-RD at screening on an IgG4-RD RI ≥4, simultaneously meeting the following definitions of relapse or refractory disease:\n\n   1. Definitions of relapse: subjects with IgG4-RD achieved remission after treatment but was active again before screening, and were classified as a high-risk group for recurrence assessed by assessment committee ;\n   2. Definitions of before screening: subjects had used glucocorticoids or glucocorticoids combined with at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs) (including cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, elorimod, thalidomide, etc.), or at least one approved biologic agent (bDMARDs) (including rituximab, abatacept, etanercept, belimumab, etc.), or targeted synthetic (ts) DMARDs (including tofacitinib, upadacitinib, baricitinib, abrocitinib, deucravacitinib, etc.) for treatment, with a total treatment duration of ≥3 months, yet still in an active disease state, ineffective, intolerant, or experiencing relapse during glucocorticoid tapering.\n5. No history of severe allergic reaction.\n6. Female participants of childbearing age must have a negative pregnancy test upon enrollment in the study; indeterminate results will not be accepted.\n7. Female subjects of childbearing age and male subjects with female partners of childbearing potential must agree to consistently use effective methods of birth control within 6 months after the last KN5601 infusion.\n8. Echocardiography show that the heart structure is basically normal and the left ventricular ejection fraction (LVEF) is ≥55%; no obvious abnormalities are found on the electrocardiogram.\n9. Pulmonary function: No severe lung disease, SpO2 ≥ 92%.\n10. All subjects' eligibility for enrollment must be confirmed by an independent Assessment Committee (AC) (the committee consists of independent data monitors and clinical experts separate from the study). They will review the eligibility of each patient based on the scores entered at screening, as well as brief descriptions provided by the investigators regarding the supporting diagnosis, scores, and the patient's clinical status in relation to enrollment criteria..\n\nExclusion Criteria:\n\n1. Presence of a condition other than IgG4-RD that (e.g., asthma) is likely to require systemic Glucocorticoids (GC) for disease control during the period of the trial.\n2. Malignancy within 5 years (except successfully treated in situ cancer, resected squamous cell or basal cell carcinoma of the skin.).\n3. During the screening visit, one of the following laboratory test values must be met, except for those caused by IgG4-RD.:\n\n   1. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal (ULN).\n   2. Total bilirubin \\> two times the ULN unless caused by Gilbert's disease. Gilbert's disease with total bilirubin \\> three times ULN.\n   3. White blood cell (WBC) count \\\u003C3.0×10⁹\u002FL;\n   4. Absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL;\n   5. Hemoglobin \\\u003C90 g\u002FL;\n   6. Platelet count \\\u003C75×10⁹\u002FL;\n   7. Estimated glomerular filtration rate (eGFR) ≤ 45 ml\u002F(min·1.73m2).\n4. Evidence suggests the presence of another uncontrolled disease, which the investigator has determined may affect the subject's participation in the trial.\n5. Active infection requiring hospitalization or treatment with systemic antimicrobial agents within the 30 days prior to treatment allocation\u002Frandomization.\n6. Received rituximab or other B-cell depleting therapies within 6 months prior to the baseline visit, unless B cells have recovered (B-cell recovery is defined as peripheral blood B-cell count ≥ the lower limit of normal reference range or returned to pre-treatment levels)。\n7. The use of supplemental oxygen at baseline.\n8. During the screening visit or within 90 days prior to the screening visit: T-SPOT positive. If the result is indeterminate, the T-SPOT must be repeated (using the same or a different T-SPOT) and shown as negative.\n9. During screening visits, individuals with a history of chronic infection or serological evidence, including:\n\n   1. Human immunodeficiency virus infection;\n   2. Hepatitis B as indicated by surface antigen or hepatitis B core antibody positivity;\n   3. Hepatitis C as indicated by anti-hepatitis C antibody positivity; if a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he\u002Fshe is negative for viral load at screening.\n10. Planned vaccination with live vaccines during the trial.\n11. Participant is pregnant or breastfeeding, or planning a pregnancy while enrolled in the study.\n12. IgG4-RD that is dominated primarily by advanced fibrotic lesions. Specifically, participants whose disease manifestations consist only of\n\n    1. retroperitoneal fibrosis,\n    2. fibrosing mediatinitis,\n    3. sclerosing mesenteritis, and\n    4. Riedel's thyroiditis. Subjects were eligible to be included only if they had non-advanced fibrotic disease in at least one organ system and otherwise met the inclusion and exclusion criteria.\n13. Evidence a SARS-CoV-2 (COVID-19) infection started within the 30 days prior to treatment allocation\u002Frandomization. Participants diagnosed with SARS-CoV-2 (COVID-19) infection more than 30 days prior to treatment .allocation\u002Frandomization must have symptoms resolved and be deemed fit to participate in the trial.\n14. Researchers consider any situations that may increase the risk to participants or interfere with the trial results (including but not limited to a history of mental illness, alcoholism, drug abuse, poor compliance, etc.).",{"count":474,"type":21},18,[51],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19\u002FBCMA CAR NK cells (KN5601) in patients with IgG4 related diseases.",[478],"IgG4 Related Disease","2025-12-21",{"date":481,"type":31},"2025-12-23",{"date":483,"type":21},"2025-12-30",{"date":485,"type":21},"2028-12-26",{"name":37,"class":38},{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":494,"targetDuration":4,"studyType":49,"phases":496,"briefSummary":497,"conditions":498,"keywords":501,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":511,"locationsCount":63},"100373734","phase-1-mutant-kras-g12v-specific-tcr-transduced-t-cell-therapy-for-advanced-pancreatic-cancer-100373734","NCT04146298","Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer","Clinical Trial Evaluating the Safety and Activity of Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer (who have received standard chemotherapy) and recurrent pancreatic cancer (who have received surgery and adjuvant chemotherapy previously).\n* Patient's tumor must express the KRAS G12V mutation, or a G12V mutation in HRAS or NRAS, as determined by DNA or RNA sequencing methods.\n* Patients must be HLA-A\\*11:01.\n* Patients with brain metastasis may be eligible if they are asymptomatic and there are fewer than 3 brain lesions that are each less than 1 cm in diameter.\n* Patients between 18 to 75 years old are eligible.\n* Patients should have good clinical performance status (ECOG 0 or 1).\n* Patients must practice birth control once enrolled into the study and for up to four months after therapy.\n* Patients must be seronegative for HIV antibody.\n* Patients must be seronegative for hepatitis B surface antigen and core antibody (or HBV non-detectable by QPCR).\n* Patients must be seronegative for hepatitis C antibody (or HCV non-detectable by QPCR).\n* Baseline hematology criteria:\n\n  * Absolute neutrophil count of at least 1000\u002Fmm\\^3.\n  * White blood cell count of at least 3000\u002Fmm\\^3.\n  * Platelet count of at least 100,000\u002Fmm\\^3.\n  * Hemoglobin \\> 8.0 g\u002FdL.\n* Baseline chemistry criteria:\n\n  * Serum ALT\u002FAST less than or equal to 3.0 x ULN.\n  * Total bilirubin less than or equal to 1.5 mg\u002FdL, unless the patient has Gilbert's Syndrome in which case total bilirubin must be less than or equal to 3.0 mg\u002FdL.\n  * Serum creatinine less than or equal to 1.6 mg\u002FdL.\n* Anticipated lifespan greater than 12 weeks.\n* Patients must be willing and able to comply with all study-related procedures and follow-up requirements.\n* Patients must be able to understand and sign a written Informed Consent Document as well as a durable power of attorney.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding.\n* Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or HIV).\n* Patients with active systemic infections, coagulation disorders, or any other major medical illnesses.\n* Patients with concurrent opportunistic infections.\n* Patients on concurrent systemic steroid therapy.\n* Patients with a history of severe immediate hypersensitivity reaction to any of the medicines used in this study (e.g., cyclophosphamide, fludarabine).\n* Patients with active coronary ischemic symptoms.\n* Patients who are receiving any other investigational agents.",{"count":495,"type":21},30,[432,292],"This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells.",[78,499,80,500],"Pancreatic Neoplasms","Advanced Cancer",[436,502,503,504],"TCR transduced T cells","adoptive cell therapy","KRAS","2025-12-18",{"date":507,"type":31},"2025-12-24",{"date":509,"type":31},"2021-10-21",{"date":443,"type":21},{"name":37,"class":38},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":519,"targetDuration":4,"studyType":49,"phases":521,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":534,"leadSponsor":536,"locationsCount":63},"100616580","phase-2-tremelimumab-combined-with-bcg-perfusion-for-the-treatment-of-hr-nmibc-after-turbt-surgery-exploration-100616580","NCT07307456","Tremelimumab Combined With BCG Perfusion for the Treatment of HR-NMIBC After TURBT Surgery Exploration","A Prospective, Open-label, Single-center Clinical Study Evaluating the Efficacy and Safety of Trastuzumab Combined With BCG Perfusion as an Adjuvant Treatment After TURBT in High-risk\u002FVery High-risk Non-muscle-invasive Bladder Cancer","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Patients with a pathological diagnosis of high-risk or very high-risk non-muscle-invasive bladder cancer (NMIBC) following transurethral resection or cystoscopic biopsy.\n\n\"High-risk patients\" must meet any one of the following criteria:\n\n1. All T1 high-grade (HG)\u002FG3 without carcinoma in situ (CIS), excluding those in the very high-risk group.\n2. All CIS patients, excluding those in the very high-risk group.\n3. Ta low-grade (LG)\u002FG2 or T1 G1 without CIS, accompanied by three risk factors.\n4. Ta HG\u002FG3 or T1 LG without CIS, accompanied by at least two risk factors.\n5. T1 G2 without CIS, accompanied by at least one risk factor. \"Very high-risk patients\" must meet any one of the following criteria:\n\n(1) Ta HG\u002FG3 with CIS accompanied by three risk factors. (2) T1 G2 with CIS accompanied by at least two risk factors. (3) T1 HG\u002FG3 with CIS accompanied by at least one risk factor. (4) T1 HG\u002FG3 without CIS, accompanied by three risk factors. (Risk factors: age \\>70 years; tumor diameter \\>3 cm; multiple papillary carcinomas) 3. No prior treatment with therapies targeting PD-1, PD-L1, PD-L2, or CTLA-4, or other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways (immune checkpoint blockers), or bacille Calmette-Guérin (BCG) therapy.\n\n4\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function, defined as meeting the following criteria (within 14 days prior to enrollment, without transfusion or granulocyte colony-stimulating factor treatment): \"Hematology\": i. Absolute neutrophil count (ANC) ≥1,000\u002Fmm³ ii. Platelet count ≥75,000\u002Fmm³ iii. Hemoglobin ≥8.0 g\u002FdL \"Hepatic function\": i. Total bilirubin ≤1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin \\>1.5 × ULN.\n\nii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.\n\n\"Renal function\": Creatinine clearance (CrCl) \\>30 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n\n6\\. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment, be willing to use effective contraception during the study period and for at least 6 months after the last dose of study drug (including chemotherapy agents and toripalimab). Male subjects with female partners of childbearing potential must agree to use effective contraception during the study period and for at least 6 months after the last dose.\n\n7\\. Subjects voluntarily agree to participate in the study by providing written informed consent, demonstrate good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria were excluded from this study:\n\n1. History or presence of muscle-invasive or disseminated\u002Fmetastatic bladder cancer. Patients with locally advanced or metastatic bladder cancer or concurrent upper tract urothelial carcinoma were excluded.\n2. Prior surgical intervention for bladder cancer other than transurethral resection of bladder tumor (TURBT) and\u002For bladder biopsy.\n3. Administration of any other approved systemic anticancer therapy or systemic immunomodulatory agents (including, but not limited to, interferon, interleukin-2, and tumor necrosis factor) within 28 days prior to enrollment.\n4. Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrollment.\n5. Major surgery or significant trauma within 28 days prior to enrollment.\n6. Vaccination with a live vaccine within 28 days prior to enrollment.\n7. Use of any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days prior to enrollment.\n8. Treatment with systemic corticosteroids within 4 weeks prior to the study intervention.\n9. Active autoimmune diseases requiring systemic treatment or other conditions necessitating long-term use of high-dose corticosteroids and other immunosuppressive agents.\n10. History of potassium, sodium, or calcium abnormalities, hypoalbuminemia, interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (including diabetes, hypertension, cardiovascular diseases, etc.) that, in the investigator's judgment, could affect the treatment.\n11. Active viral hepatitis B or C. Patients with acute or chronic active hepatitis B or C infection were excluded if they met any of the following criteria: hepatitis B virus (HBV) DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL; hepatitis C virus (HCV) RNA \\>10³ copies\u002FmL; or co-positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibody.\n12. Known history of human immunodeficiency virus (HIV) infection or known diagnosis of acquired immunodeficiency syndrome (AIDS) (no screening tests were required).\n13. History of any organ transplantation, including allogeneic stem cell transplantation, except for transplants not requiring immunosuppression (e.g., corneal transplant, hair transplant).\n14. Known history of allergic reactions to any of the study drugs.\n15. Concurrent participation in another clinical trial.\n16. History and\u002For concurrent presence of other malignancies, except for: malignancies treated with curative intent with no recurrence for over 3 years, or early-stage cancers considered cured, including completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.\n17. Active central nervous system metastases or carcinomatous meningitis.\n18. Any condition that, in the investigator's opinion, rendered the patient unsuitable for study participation (e.g., treatment not in the patient's best interest, poor patient compliance, etc.).",{"count":520,"type":21},31,[292],"This is a single-center, prospective, open-label, non-randomized clinical study initiated and conducted by the Department of Urology, Shanghai Changhai Hospital. The Principal Investigators are Professor Zhang Zhensheng and Professor Chen Guanghua. The projected study period is from December 2025 to December 2028. This study aims to evaluate the efficacy and safety of toripalimab (a PD-1 inhibitor) combined with Bacillus Calmette-Guérin (BCG) intravesical instillation as adjuvant therapy following transurethral resection of bladder tumor (TURBT) in patients with high-risk\u002Fvery high-risk non-muscle-invasive bladder cancer (NMIBC).\n\nBladder cancer is a common malignancy of the urinary system, with NMIBC accounting for approximately 75% of initial diagnoses. For high-risk patients who are unresponsive to or experience recurrence after BCG therapy, radical cystectomy remains the standard treatment. However, this procedure is associated with high rates of complications, mortality risk, and significantly negative impacts on quality of life. Therefore, exploring novel combination strategies that effectively reduce recurrence while preserving the bladder is of great clinical importance. This study is based on the successful application of immune checkpoint inhibitors in advanced urothelial carcinoma and recent Phase III trials (e.g., the CREST study) demonstrating the efficacy and safety of combining PD-1\u002FPD-L1 inhibitors with BCG in treatment-naïve high-risk NMIBC. It seeks to investigate the potential of the domestic PD-1 inhibitor toripalimab in combination with standard BCG instillation.\n\nThe study plans to enroll 31 patients with histologically confirmed high-risk\u002Fvery high-risk NMIBC who have not previously received immune checkpoint inhibitors or BCG therapy. All enrolled patients will first receive a single instillation of gemcitabine (2000mg), followed by the combination therapy phase: toripalimab (240mg, intravenous infusion, every 3 weeks for 8 cycles) combined with BCG intravesical instillation (induction phase for 6 weeks, maintenance phases at months 3 and 6). The primary efficacy endpoint is the pathological complete response (CR) rate at approximately 6 months after treatment initiation. Secondary efficacy endpoints include duration of CR, 6-month and 2-year event-free survival (EFS) rates, 1-year and 2-year cancer-specific survival (CSS) rates, time to radical cystectomy, and overall survival (OS). Safety endpoints encompass the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).\n\nStatistical analyses will be based on the Full Analysis Set (FAS) and Per-Protocol Set (PPS). The sample size calculation for the primary endpoint (6-month CR rate) is based on historical data assumptions, employing a one-sided test. Safety analyses will include all patients who received at least one dose of study treatment. This study will strictly adhere to the principles of the Declaration of Helsinki, Chinese Good Clinical Practice (GCP) guidelines, and relevant regulations. The study protocol has been submitted for review and approval by the Institutional Review Board (IRB)\u002FEthics Committee. Written informed consent will be obtained from all patients prior to participation. This study aims to provide a new and potentially more effective bladder-preserving treatment option for patients with high-risk\u002Fvery high-risk NMIBC and to evaluate the safety profile of this combination regimen.",[524],"Bladder Cancer",[526,527,528,529],"HR-NMIBC","Immunotherapy","BCG","Bladder preservation treatment","2025-12-14",{"date":532,"type":31},"2025-12-29",{"date":160,"type":31},{"date":535,"type":21},"2028-12-08",{"name":37,"class":38},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":49,"phases":546,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":231},"100599766","phase-4-low-dose-vs-standard-dose-indomethacin-for-preventing-post-ercp-pancreatitis-100599766","NCT07088757","Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis","Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography\n\nExclusion Criteria:\n\n* Standard contraindications to ERCP\n* Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)\n* Use of NSAIDs within 7 days prior to ERCP\n* Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \\[Cr \\>1.4mg\u002Fdl=120umol\u002Fl\\]; presence of coagulopathy before the procedure)\n* Acute pancreatitis within 3 days before ERCP\n* Hemodynamic instability\n* Pregnancy or lactation\n* Patients who are unwilling or unable to provide informed consent",{"count":545,"type":21},1366,[547],"PHASE4","Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP.\n\nNonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks.\n\nThis multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation.\n\nThe results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.",[550],"Post-ERCP Pancreatitis","2025-11-16",{"date":553,"type":31},"2025-11-18",{"date":555,"type":31},"2025-09-15",{"date":35,"type":21},{"name":37,"class":38},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":49,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":586},"100610653","direct-visualization-erat-versus-laparoscopic-appendectomy-in-adults-with-acute-uncomplicated-appendicitis-100610653","NCT07230379","Direct Visualization ERAT Versus Laparoscopic Appendectomy in Adults With Acute Uncomplicated Appendicitis","Direct Visualization Endoscopic Retrograde Appendicitis Therapy (ERAT) Versus Laparoscopic Appendectomy (LA) for Acute Uncomplicated Appendicitis in Adults (E-APPEND): An Open-Label, Multicenter, Randomized Controlled Non-Inferiority Trial","E-APPEND","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Diagnosis of first-episode acute uncomplicated appendicitis (AUA) confirmed by CT scan of the lower abdomen. AUA is defined as acute appendicitis without evidence of abscess, perforation, gangrene, or tumor.\n3. Provision of written informed consent.\n\nExclusion Criteria:\n\n1. Complicated appendicitis, defined as acute appendicitis with perforation, gangrene, periappendiceal abscess or phlegmon, generalized peritonitis, or radiologic evidence of extraluminal appendicolith, extraluminal air, periappendiceal fat stranding, or appendiceal mass.\n2. Severe intestinal adhesions or bowel obstruction.\n3. Intolerance or contraindication to bowel preparation or colonoscopy (e.g., intestinal perforation or bowel obstruction).\n4. Poor general condition precluding tolerance of abdominal surgery.\n5. Abdominal pain caused by other diseases as confirmed by CT or other diagnostic examinations, including inflammatory bowel disease, urinary tract disease, or gynecological disease.\n6. Pregnancy.\n7. Severe dysfunction of major organ systems, including but not limited to cardiac, pulmonary, renal, hepatic, or hematologic systems.\n8. Current enrollment in another clinical trial.\n9. Any condition that may prevent the participant from completing all study requirements.",{"count":567,"type":21},376,[106],"This study compares two ways of treating acute uncomplicated appendicitis, which is a mild form of appendicitis. In the Direct Visualization ERAT group, participants will receive Endoscopic Retrograde Appendicitis Therapy (ERAT). This is a minimally invasive, non-surgical treatment that uses a flexible endoscope passed through the colon to reach the appendix, clear the blockage, and drain the infection. In the Surgery group, participants will undergo Laparoscopic Appendectomy (LA), which is the current standard surgical treatment to remove the appendix. The purpose of this study is to determine whether ERAT is as safe and effective as standard surgery for treating uncomplicated appendicitis.\n\nBefore treatment, each participant will have a CT scan of the lower abdomen with contrast to confirm uncomplicated appendicitis and to rule out any signs of more serious infection. Participants will then be randomly assigned to either the ERAT group or the surgery group, and they will be informed of which treatment they will receive. Regardless of the group, all participants will receive the same supportive care, including pain relief, close monitoring, and a single dose of antibiotics before treatment. After the procedure, participants will stay in the hospital for at least 24 hours for observation. Follow-up will include an outpatient visit at 2 weeks, and telephone follow-ups at 1 month, 3 months, 6 months, and 1 year to monitor recovery and ensure that appendicitis does not recur.",[571],"Acute Uncomplicated Appendicitis",[573,574,575,576,577],"ERAT","Endoscopic retrograde appendicitis therapy","Appendicitis","LA","Laparoscopic appendectomy","2025-11-13",{"date":580,"type":31},"2025-11-17",{"date":582,"type":21},"2025-11",{"date":584,"type":21},"2027-11",{"name":37,"class":38},14,{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":376,"enrollmentInfo":595,"targetDuration":4,"studyType":49,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":63},"100607674","pulsed-field-ablation-of-svc-and-pv-in-paroxysmal-atrial-fibrillation-paspa-study-100607674","NCT07191626","Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)","Pulsed Field Ablation of Superior Vena Cava in Addition to Pulmonary Vein in Paroxysmal Atrial Fibrillation: A Multicenter Randomized Controlled Trial (PASPA Study)","PASPA","Inclusion Criteria:\n\n1. Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor\n2. Age between 18 and 80 years\n3. Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Intracardiac thrombus (left atrium or left atrial appendage)\n2. Left atrial anterior-posterior diameter \\> 60 mm\n3. Absolute contraindication to anticoagulation therapy\n4. Stroke or myocardial infarction within 1 month prior to enrollment\n5. Uncontrolled hyperthyroidism\n6. Pregnancy or planning pregnancy\n7. Life expectancy less than 1 year\n8. Previous atrial fibrillation ablation procedure\n9. Known or suspected AF triggers primarily originating from the SVC (based on pre-procedure mapping, if available)\n10. Inability or unwillingness to participate in the study or comply with follow-up requirements",{"count":596,"type":21},650,[106],"The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF).\n\n650 participants will be followed for 12 months. The main goal is to see if adding SVCI reduces arrhythmia recurrence without increasing complications such as phrenic nerve injury or sinus node dysfunction.",[600,601],"Paroxysmal Atrial Fibrillation","Paroxysmal Atrial Fibrillation (PAF)",[603,604,605,606,607],"Paroxysmal, Catheter Ablation","Catheter Ablation","Pulsed Field Ablation","Pulmonary Vein Isolation","Superior Vena Cava Isolation","2025-09-24",{"date":610,"type":31},"2025-09-25",{"date":612,"type":21},"2025-11-01",{"date":614,"type":21},"2027-11-01",{"name":37,"class":38},""]