[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"First Affiliated Hospital of Guangxi Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":532},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,46,79,108,132,151,177,199,224,245,272,299,327,344,364,385,411,438,462,488,511],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100642118","prospective-evaluation-of-the-2022-optic-neuritis-criteria-when-optic-neuritis-is-suspected-100642118",false,"NCT07623252","Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected","A Multicenter Prospective Diagnostic Accuracy Study of the 2022 International Criteria for Optic Neuritis and an Antibody-Stratified Adjunct in Acute or Subacute Visual Loss When Optic Neuritis Is Suspected in China","GX-ICON","Inclusion Criteria:\n\n1. Individuals presenting with a new acute or subacute episode of visual loss or optic nerve-related visual dysfunction in one or both eyes, for whom optic neuritis is considered a reasonable differential diagnosis by the treating clinical team at the initial clinical assessment and before final diagnostic adjudication.\n2. Symptom onset of the current episode within 90 days before enrollment.\n\nExclusion Criteria:\n\n1\\. The participant has previously been enrolled in this study. Each participant may be enrolled only once.\n\nA history of optic neuritis or recurrent optic neuropathy before the current episode is not an exclusion criterion.","ALL",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Optic neuritis is an important cause of acute or subacute visual loss. In clinical practice, optic neuritis must often be distinguished from other optic neuropathies, retinal diseases, anterior-segment or ocular media disorders, non-organic visual loss, and other mimics. The 2022 International Criteria for Optic Neuritis were developed to standardize the diagnosis of optic neuritis, but their performance in Chinese clinical settings, where aquaporin-4 immunoglobulin G-positive and myelin oligodendrocyte glycoprotein immunoglobulin G-positive optic neuritis are relatively common, remains uncertain.\n\nThis multicenter prospective observational study is enrolling patients with acute or subacute visual loss in whom optic neuritis is included in the differential diagnosis. The study is designed to evaluate the diagnostic performance of the 2022 International Criteria for Optic Neuritis alone and with an antibody-stratified adjunct. The index classifications will be compared with an expert-adjudicated reference-standard diagnosis. No experimental treatment is assigned by the study. All diagnostic tests and treatments are determined by the treating clinicians according to routine clinical care. Study data are collected using a structured protocol-defined case report form.",[24,25,26],"Optic Neuritis","Optic Neuropathy","Visual Loss",[28,29,30,31,32],"2022 International Criteria for Optic Neuritis","Diagnostic accuracy","Antibody-stratified adjunct","Aquaporin-4 immunoglobulin G","Myelin oligodendrocyte glycoprotein immunoglobulin G","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":37},"2025-01-06",{"date":41,"type":20},"2028-01",{"name":43,"class":44},"First Affiliated Hospital of Guangxi Medical University","OTHER",9,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100636665","multi-site-cortical-puncture-for-dor-100636665","NCT07568639","Multi-Site Cortical Puncture for DOR","Clinical Efficacy and Safety of Multiple Ovarian Cortex Punctures in Improving Ovarian Reserve and Ovarian Stimulation Outcomes in Patients With Diminished Ovarian Reserve (DOR): A Multicenter, Prospective, Randomized Controlled Clinical Trial","MSCPD","Inclusion Criteria:\n\n1. Age 20-45 years;\n2. Infertile women meeting the diagnostic criteria for diminished ovarian reserve (DOR); The following two criteria must be met simultaneously: ① Anti-Müllerian hormone (AMH) ≤0.5 ng\u002Fml, ② Bilateral ovarian antral follicles (AFC) ≤5 (3-9 mm).\n3. Patients scheduled for IVF (in vitro fertilization)\u002FICSI (intracytoplasmic sperm injection) treatment;\n4. Patients who plan for whole embryo cryopreservation and intend to undergo another ovulation induction cycle within 4 natural months starting from the first cycle, with the goal of embryo retrieval and embryo banking;\n5. Bilateral follicles were observed during AFC examination;\n6. The planned ovarian stimulation protocol is one of PPOS, antagonist, or microstimulation protocols;\n7. The first ovulation induction protocol is planned to be consistent with the second ovulation induction protocol;\n8. Voluntary participation in the study and signing of the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with the following reproductive and gynecological comorbidities: history of salpingectomy, ovarian cysts (e.g., chocolate cysts), ovarian tumors, or simple cysts ≥10 mm (not eligible for enrollment in the current cycle; may be enrolled after regression), history of ovarian surgery, endometriosis or adenomyosis, or acute pelvic inflammatory disease;\n2. Patients with abnormal ovarian position who are expected to experience difficulties during oocyte retrieval puncture;\n3. Patients with concomitant systemic severe diseases (history of severe chronic diseases such as heart failure, myocardial infarction, stroke, end-stage renal disease; advanced cancer or other terminal illnesses with an estimated survival period of less than 6 months; coagulation disorders; uncontrolled sepsis; autoimmune diseases; poor general condition rendering anesthesia and surgery intolerable);\n4. Patients with contraindications to hormone replacement therapy;\n5. Currently undergoing treatment with cytotoxic drugs, glucocorticoids or other immunosuppressants, radiotherapy or chemotherapy, or having previously received radiotherapy or chemotherapy;\n6. One spouse has chromosomal abnormalities;\n7. Patients with a history of uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders, where the investigator determines that clinical severity affects compliance with the clinical study;\n8. Patients who have undergone oocyte retrieval or ovarian puncture within the past year;\n9. Participating in other clinical trials.","FEMALE","20 Years","45 Years",{"count":58,"type":20},214,"INTERVENTIONAL",[61],"NA","A multicenter, prospective, randomized controlled clinical trial. The target population consists of patients undergoing IVF\u002FICSI artificial reproduction who plan to undergo ovarian stimulation and embryo retrieval (DOR) within 4 months. A stratified block randomization method was employed to assign participants in a 1:1 ratio to the intervention group and control group. The study aims to investigate whether multiple-point ovarian cortex puncture during the initial oocyte retrieval procedure improves ovarian reserve and ovarian stimulation outcomes in DOR patients compared to conventional oocyte retrieval techniques.",[64],"Diminished Ovarian Reserve (DOR)",[66,67,68],"Diminished ovarian reserve (DOR)","RCT","cortex punctures","NOT_YET_RECRUITING","2026-04-28",{"date":72,"type":37},"2026-05-06",{"date":74,"type":20},"2026-04-30",{"date":76,"type":20},"2030-12-30",{"name":43,"class":44},7,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":59,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100635674","an-international-multicenter-clinical-study-on-application-of-uromed-ai-doctor-based-on-large-language-models-100635674","NCT07555756","An International Multicenter Clinical Study on Application of UroMed AI Doctor Based on Large Language Models","AN INTERNATIONAL MULTICENTER CLINICAL STUDY ON APPLICATION OF UROMED AI DOCTOR BASED ON LARGE LANGUAGE MODELS","Inclusion Criteria:\n\n* Diagnosed with kidney stones, benign prostatic hyperplasia, or bladder cancer in line with the Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases (2022 Edition) and requiring hospitalization for surgery.\n\nAged 18 to 60 years with good communication skills. Voluntarily agrees to participate in the clinical study and has signed the informed consent form.\n\nExclusion Criteria:\n\n* Suffers from psychiatric disorders. Refuses to participate in medical activities involving the use of artificial intelligence systems.\n\nUnable to engage in effective communication with the research team. Has multiple underlying diseases with unstable clinical conditions.","18 Years","60 Years",{"count":89,"type":20},1080,[61],"This study evaluates our team's urology-specific AI (UroMed AI Doctor) for its safety, professionalism, knowledge and Q\\&A ability, and tests its effectiveness against traditional manual urology care, to confirm if it can be a safe auxiliary tool and improve patients' preoperative experience.\n\nBefore the study, we will test the AI with urology questions, compare it to international AI models (DeepSeek, ChatGPT, Google Gemini), and have two senior chief physicians evaluate it.\n\nIn the clinical trial, patients at The First Affiliated Hospital of Guangxi Medical University will be randomly split into two groups: AI-assisted care or traditional care by a specialist.\n\nTwo senior specialists will evaluate both groups blindly; each group will get preoperative education (AI or physician), with anxiety and satisfaction surveyed.\n\nSubsequently, a multi-center validation will be conducted with 11 domestic and international hospitals.",[93,94,95],"Kidney Calculi","Prostatic Hyperplasia","Urinary Bladder Neoplasms",[97,98],"UroMed AI Doctor","Urology","2026-04-21",{"date":101,"type":37},"2026-04-29",{"date":103,"type":20},"2026-05-01",{"date":105,"type":20},"2029-07-31",{"name":43,"class":44},5,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":116,"targetDuration":118,"studyType":21,"phases":4,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100629535","intravenous-tenecteplase-in-very-old-patients-with-acute-ischemic-stroke-100629535","NCT07475936","Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke","A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke","Inclusion Criteria:\n\n1. Age \\> 80 years;\n2. Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset;\n3. Informed consent signed by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Any contraindication to intravenous thrombolysis (excluding age);\n2. Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;\n3. Current participation in other interventional studies;\n4. The investigator deems the patient unsuitable for this study or the study might pose significant risk to the patient (e.g., due to psychiatric disorders, cognitive or emotional impairments that prevent understanding or adherence to study procedures and\u002For follow-up).","80 Years",{"count":117,"type":20},392,"90 Days","The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.",[121,122],"Acute Ischemic Stroke","Tenecteplase","2026-03-13",{"date":125,"type":37},"2026-03-17",{"date":127,"type":20},"2026-04",{"date":129,"type":20},"2027-12",{"name":43,"class":44},1,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":59,"phases":142,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":150,"locationsCount":131},"100629536","phase-3-unknown-time-of-onset-stroke-reperfusion-without-advanced-imaging-100629536","NCT07475949","Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging","Intravenous Tenecteplase for Acute Ischemic Stroke With Unknown Time of Onset Under Non-Contrast CT Selection: A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial","UTOPIA","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Clinical diagnosis of acute ischemic stroke.\n3. Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time \\>4.5 hours.\n4. Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours.\n5. National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive).\n6. Pre-stroke modified Rankin Scale (mRS) score of 0-1.\n7. Written informed consent from patients or their legally authorized representatives.\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.\n2. Rapid neurological improvement with NIHSS \\\u003C6 at randomization.\n3. Allergy to tenecteplase.\n4. Use of vitamin K antagonist with INR \\>1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours.\n5. Hypodensity on non-contrast CT \\>1\u002F3 middle cerebral artery territory.\n6. Severe traumatic brain injury or other major trauma in the past 3 months.\n7. Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm).\n8. Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.\n9. Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.\n10. Active internal bleeding.\n11. Aortic dissection.\n12. Infective endocarditis.\n13. Platelet count \\\u003C100×10\\^9\u002FL.\n14. Women who are pregnant or breastfeeding.\n15. Blood glucose \\\u003C50 or \\>400 mg\u002FdL (\\\u003C2.78 or \\>22.2 mmol\u002FL).\n16. Systolic blood presure \\>185 mmHg or diastolic blood presure \\>110 mmHg refractory to treatment.\n17. Life expectancy \\\u003C3 months.\n18. Participating in other trials.\n19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and\u002For comply with study procedures and\u002For follow-up due to psychiatric disorders, cognitive or emotional impairment).",{"count":141,"type":20},352,[143],"PHASE3","The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.",[121,122],{"date":125,"type":37},{"date":127,"type":20},{"date":149,"type":20},"2028-12",{"name":43,"class":44},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":59,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":131},"100628258","phase-3-becotatug-vedotin-plus-sintilimab-in-locoregionally-advanced-npc-100628258","NCT07459296","Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC","Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form in writing.\n2. Aged 18-70 years, male or non-pregnant female.\n3. Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).\n4. Staged as anyT N2-3 or T4N1 (9th AJCC\u002FUICC staging) without distant metastasis.\n5. ECOG performance status score of 0-1.\n6. Hemoglobin (HGB) ≥ 90 g\u002FL, neutrophil count ≥ 1.5×10⁹\u002FL, and platelet (PLT) count ≥ 100×10⁹\u002FL.\n7. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN.\n8. Normal renal function: Creatinine clearance rate ≥ 60 ml\u002Fmin (calculated using the Cockcroft-Gault formula).\n9. Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug.\n\nExclusion Criteria:\n\n1. Aged \\> 70 years or \\\u003C 18 years.\n2. Patients with recurrent or distant metastatic nasopharyngeal carcinoma.\n3. Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).\n4. Patients who have previously received radiotherapy or systemic chemotherapy.\n5. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\> 1000 copies\u002FmL or 200 IU\u002FmL.\n6. Positive for hepatitis C virus antibody (anti-HCV).\n7. Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).\n8. Patients who received systemic glucocorticoids (equivalent to prednisone \\> 10 mg\u002Fday) or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Patients who received systemic glucocorticoids equivalent to prednisone ≤ 10 mg\u002Fday, inhaled or topical glucocorticoids are eligible for enrollment.\n9. Patients with a history of active tuberculosis within the past year; patients with active tuberculosis that has been adequately treated for more than one year are eligible for enrollment. Patients with a history of other malignant tumors (except cured basal cell carcinoma or carcinoma in situ of the cervix).\n10. Patients with a history of interstitial lung disease.\n11. Patients who received live vaccines within 30 days prior to signing the informed consent form or plan to receive live vaccines in the near future.\n12. Pregnant or lactating females.\n13. Patients with a history of other malignant tumors within the past 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.\n14. Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab.\n15. Patients with known history of HIV infection.\n16. Any other conditions deemed by the investigator to potentially affect the patient's ability to sign the informed consent form, cooperate with and participate in the study, or interfere with the interpretation of results, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illnesses, or family\u002Fsocial factors.","70 Years",{"count":160,"type":20},266,[143],"This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.",[164],"Nasopharyngeal Carcinoma (NPC)",[166,167,168,169],"Nasopharyngeal Carcinoma","Becotatug Vedotin","Sintilimab","Concurrent Chemoradiotherapy",{"date":171,"type":37},"2026-03-16",{"date":173,"type":20},"2026-03-05",{"date":175,"type":20},"2032-04-01",{"name":43,"class":44},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":59,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":131},"100619261","phase-2-a-prospective-multicenter-open-label-single-arm-phase-ii-clinical-study-evaluating-the-efficacy-and-safety-of-spatially-fractionated-radiotherapy-combined-with-the-prag-strategy-for-the-treatment-of-soft-tissue-sarcoma-100619261","NCT07342322","A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With the PraG Strategy for the Treatment of Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age: 18-75 years old, both genders are eligible.\n2. Pathological Diagnosis: Histologically confirmed soft tissue sarcoma, including but not limited to:\n\n   * Undifferentiated pleomorphic sarcoma\n   * Liposarcoma\n   * Leiomyosarcoma\n   * Synovial sarcoma\n   * Fibrosarcoma\n   * Other high-grade soft tissue sarcomas\n3. Disease Stage:\n\n   * Locally advanced, unresectable soft tissue sarcoma, or\n   * Recurrent or metastatic soft tissue sarcoma\n4. Prior Therapy:\n\n   * Prior surgery, radiotherapy, or chemotherapy is allowed.\n   * At least 4 weeks since the last anti-tumor treatment.\n   * Prior treatment-related toxicities have resolved to ≤Grade 1 (except alopecia).\n5. Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria.\n6. Performance Status: ECOG performance status score of 0-2.\n7. Life Expectancy: ≥3 months.\n8. Organ Function:\n\n   * Hematology: Hemoglobin ≥50 g\u002FL, absolute neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥60×10⁹\u002FL\n   * Liver Function: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastasis)\n   * Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL\u002Fmin\n   * Cardiac Function: Left ventricular ejection fraction ≥40%\n9. Informed Consent: The patient or their legal representative has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Special Types of Sarcoma:\n\n   * Gastrointestinal Stromal Tumor (GIST)\n   * Osteosarcoma\n   * Ewing's Sarcoma\n2. Prior Treatment History:\n\n   * Previous radiotherapy to the same site with a cumulative dose that may exceed the normal tissue tolerance dose\n   * Major surgery within 4 weeks\n3. Concurrent Diseases:\n\n   * Active autoimmune diseases\n   * Diseases requiring systemic immunosuppressive therapy\n   * Severe cardiovascular diseases (myocardial infarction, unstable angina, heart failure, etc.)\n   * Severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, etc.)\n   * Active infections requiring systemic anti-infective therapy\n4. Central Nervous System Metastasis: Symptomatic brain or spinal metastasis.\n5. Pregnancy and Lactation: Women who are pregnant or breastfeeding.\n6. Allergy History: Known allergies to the drugs or their components involved in the study.","75 Years",{"count":185,"type":20},25,[187],"PHASE2","The primary objective of this clinical trial is to evaluate the efficacy and safety of spatially fractionated radiotherapy combined with the PraG strategy in the treatment of soft tissue sarcoma (STS). The main questions it aims to answer are:\n\n1. Can spatially fractionated radiotherapy combined with the PraG strategy improve the clinical prognosis of patients?\n2. What medical adverse events and clinical problems will participants encounter during the treatment with spatially fractionated radiotherapy combined with the PraG strategy? Researchers will administer a combined therapeutic regimen consisting of spatially fractionated radiotherapy, Toripalimab, recombinant human granulocyte-macrophage colony-stimulating factor injection, and Thymalfasin injection to enrolled patients, so as to observe the efficacy and safety of this therapeutic strategy for soft tissue sarcoma.\n\nParticipants will:\n\n1. The treatment will be divided into two major phases: the radiotherapy phase and the immunotherapy phase, with concomitant immunomodulatory supportive therapy administered throughout the entire treatment course.\n2. The total duration of treatment will last for 1 year starting from the first dose of medication, with regular clinical evaluations conducted according to the individual disease characteristics of each patient.\n3. Participants will receive daily oral administration of ABC or placebo for a consecutive 4 months.\n4. Routine follow-up examinations will be performed at an interval of 8\u002F12 weeks.\n5. Clinical symptoms, imaging indicators, biochemical parameters and survival status of all participants will be systematically recorded and documented throughout the study period.",[190],"Soft Tissue Sarcoma (STS)","2026-01-08",{"date":193,"type":37},"2026-01-15",{"date":195,"type":20},"2026-02-01",{"date":197,"type":20},"2029-01-31",{"name":43,"class":44},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":206,"maxAge":86,"enrollmentInfo":207,"targetDuration":4,"studyType":59,"phases":209,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100618956","early-phase-1-clinical-study-of-cll-1-car-t-in-the-treatment-of-children-with-rr-aml-100618956","NCT07338357","Clinical Study of CLL-1 CAR-T in the Treatment of Children With R\u002FR AML","A Single-Center Clinical Study Evaluating the Safety and Preliminary Efficacy of CLL-1 CAR-T in the Treatment of Children With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Voluntarily sign the ICF and are expected to complete the study's follow-up examinations and procedures.\n2. Aged 3 to 18 years (inclusive), and body weight ≥10 kg.\n3. Diagnosis of AML according to the 2016 WHO classification, meeting the diagnostic criteria for relapse and refractoriness as per the \"Chinese Guidelines for Diagnosis and Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia (2017 Edition)\", and currently having no clinically relevant treatment options or suitable registered clinical trials available.\n4. Confirmation of CLL-1 expression ≥50% on AML blasts by flow cytometry.\n5. Recovery from toxicities of prior therapies.\n6. Karnofsky score (for age ≥16 years) ≥70 or Lansky score (for age \\\u003C16 years) ≥50 at screening, and an expected survival \\>3 months.\n7. Suitable function of the liver, kidneys, hematological system, lungs and heart is required.\n8. Females subjects of childbearing potential must have a negative blood pregnancy test at screening and agree to use effective contraception during the study and within 1 year after the last dose of study drug.\n9. Male subjects with reproductive potential must agree to use barrier contraception or practice complete abstinence until 1 year after the last study treatment.\n10. Eligible blood cell specimen can be provided.\n\nExclusion Criteria:\n\n1. Diagnosis of APL.\n2. History of other malignancies within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery.\n3. Evidence of CNS involvement or cranial nerve pathology.\n4. Subjects with active infections such as hepatitis B, hepatitis C, etc., are to be excluded.\n5. Subjects with a history of severe allergies or known allergy to any drug component included in this study are to be excluded.\n6. Subjects with severe cardiac diseases, refractory hypertension, active neurological autoimmune or inflammatory diseases, clinically significant active cerebrovascular disease, oncologic emergencies requiring urgent intervention, acute or chronic GVHD, or any uncontrolled infections requiring antibiotic therapy, etc., are unsuitable for enrollment.\n7. Previous organ transplant or planned organ transplant (except for hematopoietic stem cell transplantation).\n8. Received allo-HSCT within 6 weeks prior to screening.\n9. Subjects who have recently undergone major surgery or plan to undergo major surgery, excluding diagnostic procedures and biopsies.\n10. Subjects with severe mental disorders, alcoholism, or drug abuse.\n11. Subjects who, in the judgment of the investigator, have other conditions that make them unsuitable for enrollment.","3 Years",{"count":208,"type":20},10,[210],"EARLY_PHASE1","A study to evaluate the safety and preliminary efficacy of CLL-1-targeted CAR-T cell therapy in children aged 3 to 18 years with relapsed or refractory acute myeloid leukemia (r\u002Fr AML).",[213,214],"AML (Acute Myeloid Leukemia)","CAR-T",[216,214],"R\u002FR AML","2026-01-05",{"date":219,"type":37},"2026-01-13",{"date":217,"type":20},{"date":222,"type":20},"2028-10-31",{"name":43,"class":44},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":183,"enrollmentInfo":231,"targetDuration":4,"studyType":59,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":131},"100616979","phase-2-aerosolized-mesenchymal-stem-cell-derived-exosomes-for-the-prevention-and-treatment-of-radiation-induced-oral-mucositis-100616979","NCT07312656","Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis","Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed malignant tumor of the head and neck;\n2. Age 18-75 years;\n3. Scheduled to receive radical radiotherapy with a total planned dose of ≥60 Gy, with radiation fields including the oral cavity and\u002For oropharynx;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and a life expectancy of ≥6 months.\n5. White blood cell≥3.0×10\\^9\u002FL, hemoglobin≥ 90 g\u002FL, platelet (PLT)≥ 100x10\\^9\u002F L\n6. Transaminases≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal;\n7. Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin;\n8. Cardiac: Electrocardiogram (ECG) without clinically significant abnormalities;\n9. Intact oral mucosa before initiation of radiotherapy. Absence of active oral infections or severe periodontal disease before initiation of radiotherapy;\n10. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Previous radiotherapy to the head and neck region;\n2. Head and neck surgery within the preceding 4 weeks;\n3. Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks;\n4. Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV);\n5. Severe hepatic or renal dysfunction, such as cirrhosis or chronic renal insufficiency (creatinine clearance \\\u003C30 mL\u002Fmin);\n6. Active systemic infection requiring antimicrobial therapy;\n7. Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring ongoing immunosuppressive treatment;\n8. Severe psychiatric disorders that may impair the ability to provide informed consent or adhere to the study protocol;\n9. Using other oral mucosal protective agents or anti-inflammatory medications that cannot be discontinued. Long-term use of immunosuppressants or corticosteroids at a prednisone-equivalent dose \\>10 mg\u002Fday;\n10. Individuals unable to comprehend the study requirements or comply with study procedures;\n11. Any other condition that, in the judgment of the investigator, would render the patient unsuitable for participation in the study.",{"count":232,"type":20},200,[187],"Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. According to the latest data from the International Agency for Research on Cancer (IARC), approximately 650,000 new cases of head and neck cancers are diagnosed globally each year, with about 70% of patients undergoing radiotherapy. RIOM develops through a multistep pathophysiological cascade, including initiation of mucosal injury, signaling amplification, inflammatory response, ulceration, and eventual healing. Ionizing radiation induces DNA damage in oral mucosal epithelial cells, triggering increased apoptosis. This cellular injury promotes the activation and release of pro-inflammatory mediators such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6), compromising the integrity of the mucosal barrier and ultimately leading to ulcer formation. Current clinical management of RIOM remains largely supportive, relying on oral hygiene, nutritional supplementation, and pain control, with no effective prophylactic agents available. Despite extensive research into potential interventions internationally, no drugs specifically approved by the FDA or NMPA for the prevention of RIOM have reached the market. This significant unmet clinical need calls for urgent scientific and therapeutic advancement. This study aims to evaluate the therapeutic efficacy and safety profile of aerosolized exosomes derived from mesenchymal stem cells in the prevention and treatment of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancers. The ultimate objective is to establish a novel and effective therapeutic strategy for clinical application.",[236],"Oral Mucositis (Ulcerative) Due to Radiation","2025-12-17",{"date":239,"type":37},"2025-12-31",{"date":241,"type":20},"2026-01",{"date":243,"type":20},"2028-02",{"name":43,"class":44},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":183,"enrollmentInfo":252,"targetDuration":4,"studyType":59,"phases":254,"briefSummary":255,"conditions":256,"keywords":260,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":131},"100603091","phase-3-neoadjuvant-capox-plus-tislelizumab-vs-capox-in-mss-high-risk-locally-advanced-colon-cancer-100603091","NCT07132008","Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer","Prospective, Multicenter, Randomized Trial of Neoadjuvant Capecitabine and Oxaliplatin (CAPOX) Plus Tislelizumab Versus CAPOX in Microsatellite Stable High-risk Locally Advanced Colon Cancer","Inclusion Criteria:\n\n* Age ≥18 years old and ≤75 years old.\n* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.\n* The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.\n* Enhanced CT stage T4 or T1-4 N+ without multiple primary tumors or distant metastasis.\n* The Eastern Cooperative Oncology Group physical status score is 0-1.\n* Life expectancy is expected to be more than 1 year.\n* First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.\n* Appropriate organ function is defined as follows: Hemoglobin level ≥ 60g\u002FL, Neutrophil count ≥ 1.5×10\\^9\u002FL, Platelet count ≥ 75×10\\^9\u002FL, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL.\n* Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.\n\nExclusion Criteria:\n\n* Enhanced CT stage (T1-3N0M0)\n* Multifocal colorectal cancer.\n* CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis.\n* Tumor obstruction or high risk of obstruction, bleeding, and\u002For perforation requiring emergency surgery or stent placement.\n* Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.\n* History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.\n* Acute exacerbation of important organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease, and renal insufficiency) and\u002For severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), American Society of Anesthesiologists score \\> 3 points.\n* Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.\n* Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.\n* Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy.\n* Unable to undergo enhanced CT examination\n* Pregnancy or lactation.\n* Refused to participate in this study.\n* Other situations in which the researcher deems unsuitable for this study.",{"count":253,"type":20},94,[143],"Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type colorectal cancer, as well as its impact on patient outcomes. This study aims to provide new evidence for the clinical practice of treating MSS-type colorectal cancer.",[257,258,259],"Colonic Neoplasms","Neoadjuvant Therapy","Immune Checkpoint Inhibitors",[261,262,263],"Colon cancer","Neoadjuvant chemotherapy","PD-1 inhibitor","2025-08-13",{"date":266,"type":37},"2025-08-20",{"date":268,"type":20},"2025-10-01",{"date":270,"type":20},"2030-09-30",{"name":43,"class":44},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":59,"phases":281,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100598665","phase-4-treatment-of-clonorchiasis-in-guangxi-with-albendazole-tribendimidine-and-praziquantel-100598665","NCT07074444","Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel","Albendazole, Tribendimidine, and Praziquantel for Clonorchiasis in Guangxi: A Randomized Controlled Trial Comparing Efficacy and Safety","Inclusion Criteria:\n\n1. Adults aged ≥18 years.\n2. Confirmed diagnosis of Clonorchis sinensis infection based on the latest Expert Consensus on Diagnosis and Treatment of Food-Borne Parasitic Diseases (2023): detection of eggs or adult worms in stool or bile drainage fluid.\n3. Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or allergy to albendazole, praziquantel, or tribendimidine.\n2. Electrocardiogram (ECG)-confirmed supraventricular tachycardia or atrial fibrillation.\n3. Clinically or radiologically diagnosed neurocysticercosis (brain or spinal cord) or ocular cysticercosis (eye or orbit).\n4. Presence of gallbladder stones or biliary tract obstruction as confirmed by abdominal ultrasound.\n5. Individuals with severe hepatic, renal, or cardiac dysfunction, or with active peptic ulcer disease.\n6. Pregnant or breastfeeding individuals, or those of reproductive potential (male or female) who are unwilling to use effective contraception during the study period and for 3 months following the last dose of study medication.\n7. Anticipated loss to follow-up due to relocation, withdrawal of consent, or other factors affecting adherence to the study protocol.",{"count":280,"type":20},318,[282],"PHASE4","The goal of this clinical trial is to evaluate and compare the efficacy and safety of three commonly used antiparasitic drugs-albendazole, tribendimidine, and praziquantel-for the treatment of clonorchiasis, a liver fluke infection acquired by consuming raw or undercooked freshwater fish.\n\nThis study aims to answer the following primary questions:\n\nHow effective is each drug in achieving parasitological cure, as measured by clearance of Clonorchis sinensis eggs in stool? What types and frequencies of adverse events are associated with each treatment?\n\nParticipants in this randomized, open-label trial will:\n\nBe randomly assigned to receive one of the three study drugs according to a predefined dosing regimen.\n\nProvide stool samples before treatment and at follow-up to assess for Clonorchis sinensis eggs.\n\nUndergo a second round of the same treatment regimen and repeated stool examination if eggs are still detected after the first course.\n\nAttend follow-up visits, which include symptom assessment, blood tests (hematology and liver function), and abdominal ultrasonography focusing on hepatobiliary changes.\n\nReport any side effects, discomfort, or adverse reactions experienced during or after treatment.\n\nThe findings from this study will help inform optimal therapeutic strategies for clonorchiasis in outpatient clinical settings.",[285],"Clonorchiasis",[285,287,288,289,290],"Albendazole","Praziquantel","Egg clearance rate","tribendimidine",{"date":292,"type":37},"2025-08-17",{"date":294,"type":37},"2025-07-22",{"date":296,"type":20},"2026-12-31",{"name":43,"class":44},2,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":17,"minAge":307,"maxAge":4,"enrollmentInfo":308,"targetDuration":310,"studyType":21,"phases":4,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":131},"100596063","bioabsorbable-occluder-for-outlet-vsd-safety-and-aortic-valve-effects-100596063","NCT07040579","Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects","Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function","ABSORB-VSD","Inclusion Criteria:\n\n* Age ≥1 year and weight ≥10 kg\n* Outlet VSD without ventricular malalignment\n* Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography\n* Written informed consent\n\nExclusion Criteria:\n\n* Outlet VSD with a fibrous postero-inferior rim\n* Concurrent cardiac conditions requiring surgical correction\n* Severe pulmonary hypertension (PVR \\> 5 WU, assessed by right heart catheterization )\n* Intracardiac thrombus\n* Pregnancy\n* Active systemic infection within 1 month","1 Year",{"count":309,"type":20},50,"5 Years","This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.",[313,314],"Congenital Heart Defects","VSD",[316,317,318],"transcatheter","bioabsorbable occluder","outlet VSD","2025-06-18",{"date":321,"type":37},"2025-06-27",{"date":323,"type":20},"2025-06-30",{"date":325,"type":20},"2032-12-31",{"name":43,"class":44},{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":158,"enrollmentInfo":333,"targetDuration":4,"studyType":59,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":343,"locationsCount":131},"100480767","edaravone-in-the-treatment-of-optic-neuritis-100480767","NCT05540262","Edaravone in the Treatment of Optic Neuritis","Inclusion Criteria:\n\n1. Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis\n2. Patients with a first episode of optic neuritis in either eye\n3. First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone\n\nExclusion Criteria:\n\n1. Myopia over 6 diopters\n2. Refractive media opacity affecting assessment of retinal layers and\u002For visual acuity",{"count":309,"type":20},[61],"Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.",[24],"2025-02-25",{"date":339,"type":37},"2025-02-27",{"date":341,"type":37},"2022-01-15",{"date":239,"type":20},{"name":43,"class":44},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":59,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":131},"100568353","phase-2-neoadjuvant-and-adjuvant-sintilimab-combined-with-chemoradiotherapy-versus-chemoradiotherapy-alone-in-stage-tanyn3m0-nasopharyngeal-carcinoma-100568353","NCT06680115","Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma","Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma: a Multicenter, Open-label, Randomized Phase II Clinical Trial","Inclusion Criteria:\n\n1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma;\n2. Age≥18 years;\n3. Staging TanyN3M0 (AJCC\u002FUICC 9th edition) ;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n5. White blood cell≥3.5×10\\^9\u002FL,Neutrophils≥1.5×10\\^9\u002FL, hemoglobin≥ 90 g\u002FL, platelet (PLT)≥ 100x10\\^9\u002F L ;\n6. Transaminases≤2.5 times the upper limit of normal, total bilirubin \\\u003C1.5 times the upper limit of normal;\n7. Creatinine clearance ≥60 ml\u002Fmin;\n8. Signed informed consent form.\n\nExclusion Criteria:\n\n1. HBsAg positive and HBV DNA \\>1×103 copy\u002Fml;\n2. Patients with positive HCV antibody test results;\n3. Active, known, or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, or hair loss, may be enrolled;\n4. History of interstitial lung disease;\n5. Received systemic sex hormone or other immunosuppressive therapy with equivalent dose \\> 10mg prednisone\u002Fday within 28 days before signing the informed consent. Participants with a systemic sex hormone dose ≤10mg prednisone\u002Fday or inhaled\u002Ftopical corticosteroids were enrolled;\n6. Have received or will receive live vaccine within 30 days before signing the informed consent;\n7. Pregnant or lactating women (pregnancy tests should be considered for sexually active, fertile women);\n8. Had other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer;\n9. The subject is known to have a prior allergy to macromolecular protein preparations, or any of the components of sindillizumab;\n10. Human immunodeficiency virus (HIV) infection;\n11. Other conditions, as determined by the investigator, that may affect subjects' safety or compliance with the study include symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infection requiring systemic treatment, mental illness, or family and social factors.",{"count":352,"type":20},150,[187],"To evaluate the efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Secondary endpoints included 2-year overall survival (OS), distant failure-free survival (DFFS), locoregional failure-free survival (LRFFS), and adverse events.",[164],"2024-11-06",{"date":358,"type":37},"2024-11-08",{"date":360,"type":20},"2024-11",{"date":362,"type":20},"2029-12",{"name":43,"class":44},{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":59,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":131},"100568203","early-phase-1-a-pilot-study-on-the-safety-and-efficacy-of-yolt-204-for-transfusion-dependent-beta-thalassemia-100568203","NCT06678165","A Pilot Study on the Safety and Efficacy of YOLT-204 for Transfusion-Dependent Beta-Thalassemia","Inclusion Criteria：\n\n1. Age between 18 to 35 years, gender not limited.\n2. The patient has fully understood this study and voluntarily signed an informed consent form.\n3. Clinically diagnosed as a patient with transfusion-dependent β-thalassemia, excluding the genotype: β0β0.\n4. Karnofsky Performance Status (KPS) score of at least 70.\n5. Obtain detailed medical records of red blood cell transfusions within 2 years prior to the patient signing the informed consent form, including the volume or units of transfusion and the levels of red blood cells and hemoglobin before and after transfusion.\n6. No severe hematopoietic dysfunction, with heart, lung, liver, and kidney functions essentially normal.\n7. Coagulation function: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) both ≤1.5×ULN (Upper Limit of Normal).\n8. Renal function: Creatinine ≤1.5×ULN, or when creatinine \\>1.5×ULN, the creatinine clearance is \\>50ml\u002Fmin (calculated according to the Cockcroft-Gault formula).\n9. Liver function: Alanine Aminotransferase (ALT) ≤3×ULN and Aspartate Aminotransferase (AST) ≤3×ULN; Direct Bilirubin ≤2.5×ULN.\n10. Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥50%.\n11. Good compliance, willing to adhere to visit schedules, trial plans, laboratory tests, and other trial steps.\n12. Willing to participate in long-term follow-up studies.\n\nExclusion Criteria:\n\n1. History of multiple drug allergies or a history of allergic reactions to oligonucleotides or lipid nanoparticles (LNPs).\n2. Diagnosed with compound alpha-thalassemia.\n3. Clinically significant active bacterial, viral, fungal, or parasitic infections at the time of screening, as judged by the investigator.\n4. White blood cell count (WBC) \\\u003C3×10\\^9\u002FL and\u002For platelet count \\\u003C100×10\\^9\u002FL not due to hypersplenism, as judged by the investigator.\n5. Uncorrected bleeding disorders.\n6. Received treatment with erythropoietin (EPO) within the three months prior to enrollment.\n7. Severe iron overload, with serum ferritin levels ≥5000 ng\u002Fml.\n8. Positive for hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus, antibodies to human immunodeficiency virus (HIV), or specific antibodies to Treponema pallidum (syphilis).\n9. History of hematopoietic stem cell transplantation, gene therapy, or gene editing therapy.\n10. Participation in another clinical study and use of investigational drugs within 3 months prior to starting the study drug.\n11. History or current presence of malignant tumors or myeloproliferative diseases or immunodeficiency diseases.\n12. Presence of severe mental illness that prevents cooperation with treatment; significant pulmonary arterial hypertension requiring medical intervention; recent malaria; a history of hematological tumors in immediate family members.\n13. Any past or current disease, treatment, or laboratory abnormality that may interfere with the study results, affect the patient's full participation in the study, or that the investigator deems unsuitable for participation in this clinical study.","35 Years",{"count":372,"type":20},3,[210],"This study is a single-arm, open-label, dose-escalation trial, planning to enroll 3-9 patients with transfusion-dependent β-thalassemia, aimed at assessing the safety and tolerability of a single-dose of YOLT-204 in patients with transfusion-dependent β-thalassemia; to preliminarily evaluate the impact of a single -dose of YOLT-204 on the levels of fetal hemoglobin in the plasma",[376],"Transfusion Dependent Beta Thalassemia","2024-11-05",{"date":379,"type":37},"2024-11-07",{"date":381,"type":20},"2024-12-31",{"date":383,"type":20},"2026-06-01",{"name":43,"class":44},{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":158,"enrollmentInfo":392,"targetDuration":4,"studyType":59,"phases":394,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100507820","effect-of-immunonutrients-on-oral-mucositis-in-nasopharyngeal-carcinoma-patients-after-chemoradiotherapy-100507820","NCT05892354","Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy","Efficacy of Immunonutrients in Reducing Oral Mucositis in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n2. Age 18-70 years old, male or non-pregnant women;\n3. Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated,WHO type II or III);\n4. Newly diagnosed stage III-IVa (8th AJCC\u002FUICC stage) NPC patients;\n5. The levels of major organ function meet the following criteria:\n\n(1)Hematology: WBC ≥ 3.0 × 10\\^9\u002FL, ANC ≥ 1.5 × 10\\^9\u002FL, PLT ≥ 100 × 10\\^9\u002FL, HGB ≥ 90 g\u002FL; (2) Liver function: ALT, AST≤2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN; (3) Renal function: BUN and CRE ≤ 1.5 × ULN or an estimated glomerular filtration rate (eGFR) ≥ 60 ml\u002Fmin (calculated using the Cockcroft-Gault equation); (4) Adequate coagulation function: defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the ULN; (5) Normal levels of cardiac enzymes; 6. The patient has signed informed consent forms and is able to comply with the study's planned visits, treatment plans, and laboratory tests.\n\nExclusion Criteria:\n\n1. History of investigational Oral Impact®\u002FENSURE® use within the month prior to enrollment;\n2. Known allergy or intolerance to any component of investigational Oral Impact®\u002FENSURE® or related chemotherapy drugs;\n3. Poor glycemic control in patients with diabetes;\n4. Patients with autoimmune diseases;\n5. Patients with active infections;\n6. Patients who have received radiation therapy or other anti-tumor treatments in the past;\n7. Patients with a history of other malignant tumors;\n8. Presence of oral mucositis at baseline;\n9. Malnutrition at baseline;\n10. Patients who cannot eat the required amount of food at baseline and require parenteral or enteral nutrition;\n11. Inability to eat soft solid foods at baseline;\n12. History of human immunodeficiency virus (HIV) or active hepatitis B\u002FC virus infection;\n13. Participation in other intervention clinical studies within one month;\n14. Subjects deemed by the investigator to have other factors that may force them to terminate the study, such as having other serious illnesses (including mental illnesses) that require concomitant treatment, significantly abnormal laboratory test results, or family or social factors that may affect subject safety or data collection.",{"count":393,"type":20},190,[61],"The purpose of this study was to investigate the role of immunonutrion compared with standard nutrition in reducing oral mucositis in patients with locally advanced nasopharyngeal carcinoma.",[397],"Locally Advanced Nasopharyngeal Carcinoma",[399,166,400,401],"Immunonutrition","Chemoradiotherapy","Oral Mucositis","2024-08-05",{"date":404,"type":37},"2024-08-07",{"date":406,"type":37},"2023-06-12",{"date":408,"type":20},"2027-04-01",{"name":43,"class":44},20,{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":59,"phases":420,"briefSummary":421,"conditions":422,"keywords":426,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":131},"100535645","phase-2-the-effects-of-neoadjuvant-tislelizumab-combined-with-chemotherapy-in-locally-advanced-mss-rectal-cancer-100535645","NCT06254521","The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer","Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study","Inclusion Criteria:\n\n* Age ≥18 years old and ≤70 years old.\n* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.\n* The lower edge of the tumor is less than 12cm from the anus as measured by colonoscopy and MRI,or TRUS.\n* It was confirmed by magnetic resonance imaging (MRI) or intracavitary ultrasound of the rectum as T3-4 or N+, and M0 by enhanced CT.\n* The ECOG physical status score is 0-1.\n* Life expectancy is expected to be more than 1 year.\n* First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.\n* Appropriate organ function is defined as follows: Hemoglobin level ≥ 90g\u002FL, Neutrophil count ≥ 1.5×10\\^9\u002FL, Platelet count ≥ 75×10\\^9\u002FL, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL.\n* Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.\n\nExclusion Criteria:\n\n* Early rectal cancer (T1-2N0M0); The lower margin of the tumor was less than 5cm from the anus and T4. APR(combined abdominal perineal resection) is required;\n* Multifocal colorectal cancer.\n* Tumor obstruction or high risk of obstruction, bleeding, and\u002For perforation requiring emergency surgery or stent placement.\n* Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.\n* History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.\n* Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and\u002For severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score \\> 3 points.\n* Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.\n* Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.\n* Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy.\n* Unable to undergo enhanced CT examination\n* Pregnancy or lactation.\n* Refused to participate in this study.\n* Other situations in which the researcher deems unsuitable for this study.",{"count":419,"type":20},60,[187],"This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.",[423,424,425],"Rectal Cancer","Rectal Cancer Stage II","Rectal Cancer Stage III",[427,428,429],"locally advanced rectal cancer","neoadjuvant","PD-1","2024-02-03",{"date":432,"type":37},"2024-02-12",{"date":434,"type":20},"2024-02-22",{"date":436,"type":20},"2027-12-30",{"name":43,"class":44},{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":54,"minAge":86,"maxAge":158,"enrollmentInfo":445,"targetDuration":4,"studyType":59,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":131},"100478565","phase-2-tislelizumab-combined-with-concurrent-chemoradiotherapy-as-first-line-treatment-for-stage-iiic2-cervical-cancer-100478565","NCT05511623","Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer","Efficacy and Safety of Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer","Inclusion criteria:\n\n(1)18-70 years old; (2)Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; (3)Patients with 2018 FIGO stage IIIC2 cervical cancer; (4)At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; (5)Eastern Cooperative Oncology Group score 0-1; (6)No metastatic diseases; (7)Must have an average life expectancy of 6 months; (8)Participants must have normal organ and marrow function as defined below: (hemoglobin ≥90g\u002FL,neutrophils ≥1.5×109\u002FL, platelets ≥80×109\u002FL, ALB≥30g\u002FL, Total bilirubin≤1.5 x institutional upper limit of normal, AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal, Creatinine clearance≥60 mL\u002Fmin; (9)Patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; (10)Patients volunteered to participate in the study and sign the informed consent.\n\nExclusion criteria:\n\n1. Diagnosed with any other cancer within the past 5 years;\n2. Known allergy to any component of the drug;\n3. Congenital or acquired immune deficiency (such as HIV infection);\n4. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Medical history of vitiligo; asthma which requires bronchodilators for medical intervention;\n5. Active infection requiring systemic treatment;\n6. Previously treatment with PD-1 and\u002For PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors;\n7. Patients with grade\\>2 unrelieved toxic reactions (based on National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] version 5.0) caused by any previous treatment;\n8. With a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis;\n9. Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks;\n10. Pregnant or lactating women;\n11. With metastatic diseases;\n12. Liver\u002Frenal insufficiency;\n13. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders;\n14. Those who have participated in clinical trials with other drugs within 4 weeks;\n15. Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator;\n16. Patients could not gain the maximum benefit from this study judged by the investigator.",{"count":446,"type":20},112,[187],"To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.",[450],"Cervical Cancer",[452,429,453],"cervical carcinoma","chemoradiotherapy","2023-09-08",{"date":456,"type":37},"2023-09-11",{"date":458,"type":37},"2022-09-01",{"date":460,"type":20},"2027-12-31",{"name":43,"class":44},{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":17,"minAge":310,"maxAge":370,"enrollmentInfo":469,"targetDuration":4,"studyType":59,"phases":470,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":131},"100497843","early-phase-1-a-study-evaluating-the-safety-and-efficacy-of-lentired-drug-product-in-transfusion-dependent--thalassemia-tdt-100497843","NCT05762510","A Study Evaluating the Safety and Efficacy of LentiRed Drug Product in Transfusion-dependent β-Thalassemia [TDT]","An Open Label Study Evaluating the Safety and Efficacy of Gene Therapy for Transfusion-dependent β-Thalassemia by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a LentiRed Lentiviral Vector (GMCN-508B Drug Product, Also Called LentiRed)","Inclusion Criteria:\n\n1. The subject himself\u002Fherself or one legal guardian\u002Fagent of the subject is required to fully understand the study and voluntarily sign a written informed consent.\n2. Ages 5 to 35, no gender limitation.\n3. The clinical diagnosis of TDT includes β0\u002Fβ0, β+\u002Fβ0, βE\u002Fβ0 and β+\u002Fβ+ genotypes. TDT was defined as severe anemia in patients with thalassemia (Hb persistent \\\u003C70 g\u002FL), regular RBC transfusion and standard iron removal therapy to survive for life.\n4. Karnofsky Level of Performance (KPS) score ≥70 in adult subjects and Lansky Level of Performance (LPS) score ≥70 in children subjects.\n5. Subjects were determined to undergo autologous hematopoietic stem cell transplantation by the principle investigator.\n6. Subjects must have been treated and followed for at least the past 2 years in a specialized center that maintained detailed medical records, including transfusion history.\n\nExclusion Criteria:\n\n1. Hepatitis B virus (HBV) : HbsAg or HbcAb positive, nucleic acid test positive; Hepatitis C virus (HCV) : HCAb positive, nucleic acid test positive; Positive for Human immunodeficiency virus (HIV) antibody or Treponema pallidum (TP) specific antibody; Tuberculosis: positive interferon gamma release test.\n2. A white blood cell (WBC) count \\\u003C3×10\\^9\u002FL and\u002For platelet count \\\u003C100×10\\^9\u002FL, splenectomy was performed before.\n3. Uncured bleeding abnormalities.\n4. Any previous or current malignancy, myeloproliferative disease, or immune deficiency disease.\n5. Immediate family member with a known or suspected Familial Cancer Syndrome (including but not limited to hereditary breast and ovarian cancer syndromes, hereditary non-polyposis colorectal cancer syndromes and familial adenomatous polyposis).\n6. Previous hematopoietic stem cell transplantation (HSCT).\n7. Advanced liver disease, defined as: 1) Baseline alanine aminotransferase (ALT) or direct bilirubin ≥3 normal upper limit (ULN), or 2) Liver biopsy demonstrating cirrhosis, any evidence of bridging fibrosis, or acute hepatitis.\n8. Baseline estimated glomerular filtration rate (eGFR) \\\u003C 70 mL\u002Fmin \u002F1.73 m2, as determined using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation for ≥18 years of age, and Besides Schwartz Equation calculator \\\u003C 18 years of age.\n9. Uncontrolled seizure disorder.\n10. Diffusion capacity of Carbon monoxide dispersion (DLco) \\\u003C50% of predicted (corrected for hemoglobin and or alveolar ventilation, as clinically indicated ).\n11. A cardiac T2\\* \\\u003C20 ms by magnetic resonance imaging (MRI).\n12. Severe iron overload, which in the opinion of the physician is grounds for exclusion.\n13. Clinically significant pulmonary hypertension.\n14. Participation in another clinical study with an investigational drug within 30 days of screening.\n15. Failure to obtain appropriate informed consent.\n16. Any other condition that would render the subject ineligible for HSCT, as determined by the attending transplant physician or investigator.\n17. Contraindications to the conditioning regimen.\n18. Prior receipt of genetic stem cell therapy.\n19. Diagnosis of significant psychiatric disorder of the subject that could seriously impede the ability to participate in the study.\n20. Pregnancy or breastfeeding in a postpartum female or absence of adequate contraception for fertile subjects. Females of child-bearing potential are required to use effective contraception from the screening period until at least 6 months after drug product infusion. Male subjects are also required to use effective contraception (including condoms) from the screening period until at least 6 months after drug product infusion.\n21. Live vaccines were administered within 6 weeks prior to screening.\n22. Known history of hypersensitivity to the ingredients used in the trial.\n23. An assessment by the investigator that the subject would not comply with the study procedures outlined in the protocol.",{"count":107,"type":20},[210],"This is a single-arm, open label, single-dose study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CD34+ Human Hematopoietic Stem Cells that was transduced with LentiRed Lentivrial vector.",[473],"Transfusion Dependent Beta-Thalassemia",[475,476,477,478,479],"LentiRed","Beta-Thalassemia","Human Hematopoietic Stem Cell","gene therapy","CD34+","2023-05-05",{"date":482,"type":37},"2023-05-09",{"date":484,"type":37},"2023-02-22",{"date":486,"type":20},"2030-10-31",{"name":43,"class":44},{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":17,"minAge":310,"maxAge":370,"enrollmentInfo":495,"targetDuration":4,"studyType":59,"phases":496,"briefSummary":498,"conditions":499,"keywords":501,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":131},"100497438","phase-1-a-study-evaluating-the-safety-and-efficacy-of-the-gmcn-508a-drug-product-in-transfusion-dependent--thalassemia-participants-100497438","NCT05757245","A Study Evaluating the Safety and Efficacy of the GMCN-508A Drug Product in Transfusion-dependent α-Thalassemia Participants","A Phase 1 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy in Subjects With Transfusion-dependent α-Thalassemia by Transplantation of Autologous CD34+ Cells Transduced Ex Vivo With a Lentiviral Vector (GMCN-508A Drug Product)","Inclusion Criteria:\n\n1. The subject himself\u002Fherself or one legal guardian\u002Fagent of the subject is required to fully understand the study and voluntarily sign a written informed consent.\n2. Ages 5 to 35, no gender limitation.\n3. The clinical diagnosis of Transfusion-dependent α-Thalassemia.Transfusion dependence was defined as ≥6 Units of transfusions of pRBCs for the prior 24 weeks without \\>56 days of non-transfusion.\n4. Karnofsky Level of Performance (KPS) score or Lansky Level of Performance (LPS) score ≥70.\n5. Subjects were determined to undergo autologous hematopoietic stem cell transplantation and conditioning procedure by the principle investigator.\n6. Subjects were willing to comply with the protocol.\n7. Fertile Subjects are willing to take effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n1. Diagnosed with mild α-thalassemia, Hb Bart's edema, ATRx α-thalassemia, hemoglobin S\u002Fβ-thalassemia, myelodysplastic subtype anemia, or with HbE homozygous β gene mutation, or with any type of β-thalassemia Thalassemia.\n2. Uncorreted Bleeding disorders with frequent bleeding (eg, menorrhagia, epistaxis, coagulation disorders).\n3. Bacterial, fungal, parasitic or viral infection as determined by the investigator to be clinically significant.\n4. Presence of severe iron overload.\n5. Any prior or current malignancy, myeloproliferative disorders or immunodeficiency disorders.\n6. Any major medical disease, laboratory test abnormality or mental illness that would render the participant ineligible for the study.\n7. Immediate family member with a known Familial Cancer Syndrome.\n8. Prior receipt of gene therapy, allogeneic bone marrow transplantation or allogeneic hematopoietic stem cell transplantation.\n9. Participation in another clinical study with an investigational drug 3 months prior to Screening.\n10. Pregnancy, plan to be pregnant during study or breastfeeding in a postpartum female.\n11. Known hypersensitivity to any ingredients or excipients of the test drug.\n12. Eligible for allogeneic bone marrow transplantation or allogeneic hematopoietic stem cell transplantation with a known and available donor.\n13. Any other condition that would render the participant ineligible for the study, as determined by the investigator.",{"count":107,"type":20},[497],"PHASE1","This is a non-randomized, open label, single-site, single-dose, phase 1 study in up to 5 participants (between 5 and 35 years of age, inclusive) with Transfusion-dependent α-thalassemia. The study will evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (HSCT) using GMCN-508A Drug Product \\[autologous CD34+ hematopoietic stem cells transduced with GMCN-508A lentiviral vector encoding the human α-globin gene\\].",[500],"Transfusion-dependent α-Thalassemia",[502,478,500,477],"GMCN-508A","2023-04-16",{"date":505,"type":37},"2023-04-18",{"date":507,"type":20},"2023-05-08",{"date":509,"type":20},"2030-12-31",{"name":43,"class":44},{"id":512,"slug":513,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":518,"enrollmentInfo":519,"targetDuration":4,"studyType":59,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100396839","phase-2-toripalimab-endostar-combined-with-radiotherapy-and-chemotherapy-for-nasopharyngeal-carcinoma-100396839","NCT04447326","Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy for Nasopharyngeal Carcinoma","Randomized Controlled, Multicenter Phase II Clinical Research of Toripalimab (PD-1 Inhibitor) and Endostar Combined With Radiotherapy and Chemotherapy in the Treatment of High-risk Locally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. With ECOG score 0-1.\n2. Subjective aged 18-65 years, male or non-pregnant female.\n3. Pathologically diagnosed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., the WHO type II or III).\n4. Stage IVa (8th AJCC\u002FUICC stage) T4 and\u002For N3, untreated patients with nasopharyngeal carcinoma.\n5. Agreeing to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissues, which were sent to the central laboratory for the PD-L1 IHC test.\n6. Hematology: white blood cells ≥ 4000 \u002FμL; neutrophils ≥ 2000 \u002FμL; hemoglobin ≥ 9 g\u002FdL; and platelets ≥ 100000 \u002FμL.\n7. Liver function: ALT and AST lower than the 1.5 times (1.5 × ) the upper limits of normal (ULN); and total bilirubin \\\u003C 1.5 × ULN.\n8. Renal function: serum creatinine \\\u003C 1.5 × ULN.\n9. Patients signing the informed consents, and willing and able to follow the study plan (visit and treatment plan), laboratory tests, and other research procedures.\n\nExclusion criteria:\n\n1. Patients with nasopharyngeal carcinoma with recurrence and distant metastasis.\n2. Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO classification type I).\n3. Patients who had undergone radiotherapy or systemic chemotherapy.\n4. Pregnant or breastfeeding females, or females in fertility period while with no effective contraceptive measures.\n5. Positive for HIV.\n6. Having suffered from other malignant tumors (except for the cured basal cell carcinoma or cervical carcinoma in situ).\n7. Having been treated with inhibitors of immune regulatory points (i.e., CTLA-4, PD-1, PD-L1, etc.).\n8. With complications needing long-term application of immunosuppressive drugs, or systemic or local application of corticosteroids with immunosuppressive doses of comorbidities.\n9. Patients with immunodeficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; patients suffering from vitiligo, or asthma in childhood completely relieved, with no need of any intervention after adulthood could be included; and patients with asthma requiring bronchodilators for medical intervention could not be included).\n10. With excessive usage of glucocorticoids within 4 weeks.\n11. Whose laboratory examination values that did not meet the relevant standards within 7 days before participating in the research.\n12. Patients with markedly reduced heart, liver, lung, kidney and\u002For bone marrow functions.\n13. With serious and uncontrolled medical diseases and infections.\n14. Using other test drugs or in other clinical trials.\n15. Refusing or failing to sign the informed consent to participate in the trial.\n16. With other treatment contraindications.\n17. With personality or mental illness, with no or limited civil capacity.\n18. Positive for hepatitis B surface antigen (HBsAg), and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 cps\u002FmL.\n19. Patients positive for the HCV antibody test could only be included in this study with the negative results from the HCV RNA polymerase chain reaction test.\n20. Unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.","65 Years",{"count":520,"type":20},106,[187],"This study is to investigate the efficacy and safety of the induction chemotherapy + concurrent chemoradiotherapy（CCRT）combined with toripalimab and endostar treatment, in comparison with the induction chemotherapy + concurrent chemoradiotherapy（CCRT）, in treating locally advanced high-risk nasopharyngeal carcinoma",[166],"2020-06-24",{"date":526,"type":37},"2020-06-25",{"date":528,"type":20},"2020-06",{"date":530,"type":20},"2026-06",{"name":43,"class":44},""]