[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The First Affiliated Hospital of Zhengzhou University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":587},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,50,0,25,[9,46,70,95,119,141,165,180,213,243,264,285,306,326,346,370,398,418,437,457,479,500,524,547,570],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100639828","phase-3-pro-urokinase-for-extended-window-posterior-circulation-stroke-100639828",false,"NCT07617870","Pro-urokinase for Extended-Window Posterior Circulation Stroke","Pro-urokinase for Reperfusion in Acute pOsterior Circulation ischeMIc Stroke in the Extended Window (the PROMISE Trail): A Randomized, Double-blind, Baseline Treatment-controlled Study","PROMISE","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);\n3. Imaging criteria:\n\n   1. DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;\n   2. DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;\n4. NIHSS score 4-25;\n5. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);\n6. Signed informed consent from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Planned endovascular treatment;\n2. Contradictory to MRI examination;\n3. MRI image not qualified for evaluation;\n4. Serious neurological deficits before onset (mRS≥2);\n5. Obvious head injuries or strokes within 3 months;\n6. Subarachnoid or intracranial hemorrhage;\n7. History of intracranial hemorrhage;\n8. Intracranial tumor, arteriovenous malformation or aneurysm;\n9. Intracranial or spinal cord surgery within 3 months;\n10. Active internal hemorrhage;\n11. platelet count of \\\u003C100000\u002Fmm3;\n12. Aortic arch dissection;\n13. Heparin therapy within 24 hours;\n14. Oral warfarin is being taken and INR\\>1.6 or APTT abnormal;\n15. Oral anticoagulation therapy;\n16. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;\n17. Blood glucose \\\u003C 50 mg\u002Fdl (2.7mmol\u002FL);\n18. Pregnancy;\n19. Neurological deficit after epileptic seizures;\n20. Major surgery within 1 month;\n21. Gastrointestinal or urinary tract hemorrhage within the previous 30 days;\n22. Myocardial infarction within 3 months;\n23. Allergy to study drugs;\n24. Unlikely to adhere to the trial protocol or follow-up;\n25. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;\n26. Participation in other interventional clinical trials within the previous 3 months.","ALL","18 Years",{"count":21,"type":22},586,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study aims to evaluate whether, in patients with imaging-confirmed acute ischemic stroke of the posterior circulation presenting within 4.5-24 hours after symptom onset and not scheduled for endovascular thrombectomy, intravenous thrombolysis with recombinant human prourokinase (rhPro-UK), compared with standard medical treatment, can achieve superior 90-day functional outcomes with a higher level of safety.",[28],"Acute Ischemic Stroke",[30,31,32,33],"Recombinant human prourokinase (rhPro-UK)","Posterior circulation ischemic stroke","Extended-window thrombolysis","Intravenous thrombolytic therapy","NOT_YET_RECRUITING","2026-05-26",{"date":37,"type":38},"2026-06-01","ACTUAL",{"date":37,"type":22},{"date":41,"type":22},"2028-06-30",{"name":43,"class":44},"The First Affiliated Hospital of Zhengzhou University","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100361976","newborns-from-patients-treated-with-art-assisted-reproductive-technology-100361976","NCT03993158","Newborns From Patients Treated With ART (Assisted Reproductive Technology)","Prospective Cohort Study for Newborns From Patients Treated With ART in Clinical Reproductive Medicine Management System\u002FElectronic Medical Record Cohort Database (CCRM\u002FEMRCD)","Inclusion Criteria:\n\n* All newborns from patients treated with ART in our center.\n\nExclusion Criteria:\n\n\\-","0 Weeks","40 Years",{"count":56,"type":22},10000,"OBSERVATIONAL","The Prospective Cohort Study for Newborns from patients treated with ART was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.",[60],"Health Related","RECRUITING","2026-05-24",{"date":64,"type":38},"2026-05-27",{"date":66,"type":38},"2010-01-01",{"date":68,"type":22},"2050-12-31",{"name":43,"class":44},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":45},"100639868","phase-1-a-prospective-single-arm-clinical-study-on-the-safety-and-efficacy-of-ivoximab-combined-with-temozolomide-in-the-treatment-of-relapsedrefractory-glioma-100639868","NCT07599371","A Prospective, Single-arm Clinical Study on the Safety and Efficacy of Ivoximab Combined With Temozolomide in the Treatment of Relapsed\u002FRefractory Glioma","Inclusion Criteria:\n\n* Relapsed\u002Frefractory glioma confirmed by histology and clinical imaging; ECOG performance status score of 0-1; Expected survival time ≥ 6 months; Adequate organ function, as demonstrated by meeting the following laboratory parameters; For female subjects of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Cycle 1, Day 1), and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required. A female of non-childbearing potential is defined as being postmenopausal for at least one year, or having undergone surgical sterilization or hysterectomy； If there is a risk of pregnancy, all subjects (both male and female) must use contraceptive measures with a failure rate of less than 1% per year throughout the entire treatment period until 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy).\n\nExclusion Criteria:\n\n* Diagnosis of another malignancy within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radically resected carcinoma in situ); Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); Receipt of systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first dose; Active autoimmune disease requiring systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; Receipt of systemic glucocorticoid therapy (excluding nasal spray, inhaled, or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose; Note: Physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) are permitted; Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; Known allergy to any drug used in this study; Presence of factors affecting oral administration of temozolomide (e.g., inability to swallow, intestinal obstruction, etc.); Failure to fully recover from toxicity and\u002For complications caused by any previous intervention prior to the start of treatment (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia); Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive); Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number above the upper limit of normal of the testing center's laboratory); Subjects with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); Receipt of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated influenza vaccines administered by injection for seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal live attenuated influenza vaccines are not permitted.\n\nPregnant or breastfeeding women; Presence of any severe or uncontrolled systemic disease; Evidence of medical history or disease, treatment, or abnormal laboratory values that may interfere with the study results or prevent the subject from fully participating in the study, or other conditions deemed by the investigator as unsuitable for enrollment, including potential risks that the investigator believes would make participation in this study inappropriate.","85 Years",{"count":78,"type":22},29,[80,81],"PHASE1","PHASE2","This study is a prospective, single-arm clinical trial aimed at evaluating the safety and efficacy of ivoximab combined with temozolomide in the treatment of relapsed\u002Frefractory glioma. The study plans to enroll 29 patients with relapsed\u002Frefractory glioma. After signing informed consent and meeting the inclusion\u002Fexclusion criteria through screening, patients will receive treatment with ivoximab combined with temozolomide. Efficacy evaluation will be conducted every two treatment cycles using the Response Assessment in Neuro-Oncology (RANO 2.0) criteria, and treatment will continue until disease progression or intolerance to the combined regimen.",[84],"Relapsed\u002FRefractory Glioma",[86],"relapsed\u002Frefractory glioma","2026-05-14",{"date":89,"type":38},"2026-05-20",{"date":91,"type":38},"2024-10-10",{"date":93,"type":22},"2028-10-10",{"name":43,"class":44},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":118,"locationsCount":45},"100634494","phase-3-tenecteplase-for-late-window-stroke-guided-by-dwi-flair-mismatch-100634494","NCT07540416","Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch","Tenecteplase Thrombolysis for Acute Ischemic Stroke in the 4.5-9-Hour Window Guided by DWI-FLAIR Mismatch: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial","TRUST-MISMATCH",{"count":103,"type":22},564,[25],"The goal of this clinical trial is to evaluate the efficacy and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are:\n\n1. Does tenecteplase improve functional outcomes at 90 days compared with standard treatments in AIS patients administered 4.5-9 hours after stroke onset guided by DWI-FLAIR mismatch?\n2. The safety of tenecteplase thrombolysis for AIS patients in the 4.5-9 hours guided by DWI-FLAIR mismatch.\n\nResearchers will compare tenecteplase to placebo to see if it is effective and safe for these patients.\n\nParticipants will be randomly assigned (1:1) immediately after randomization:\n\n* Tenecteplase group: received tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg).\n* Control group: aspirin (300 mg) plus tenecteplase placebo. From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.",[28],[108,109,110,111],"Tenecteplase","Thrombolysis","diffusion weighted imaging","fluid attenuated inversion recovery","2026-04-17",{"date":114,"type":38},"2026-04-20",{"date":116,"type":22},"2026-05-01",{"date":41,"type":22},{"name":43,"class":44},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":45},"100615596","phase-2-pd1tgf-in-combination-with-shr2554-or-apatinib-and-chemotherapy-for-first---line-treatment-of-gastric-cancer-100615596","NCT07294664","PD1\u002FTGFβ In Combination With SHR2554 or Apatinib And Chemotherapy For First - Line Treatment Of Gastric Cancer","Clinical Study of SHR1701 in Combination With CAPOX and SHR2554 or Apatinib for First-line Treatment of Advanced Gastric Cancer","Inclusion Criteria:\n\n1. Patients voluntarily agree to participate in this study and sign the informed consent form;\n2. Age ≥ 18 years;\n3. ECOG PS score 0-2;\n4. Pathologically confirmed adenocarcinoma of the stomach\u002Fgastroesophageal junction;\n5. Clinical staging based on contrast - enhanced CT\u002FMRI (with endoscopic ultrasound and diagnostic laparoscopy if necessary). Patients with stage III-IV (8th edition of the AJCC Gastric Cancer TNM Staging) non - resectable locally advanced or metastatic disease; the feasibility of curative surgery for patients is determined by multidisciplinary team (MDT) discussion;\n6. Patients who have not previously received systemic therapy for advanced disease;Note: Neoadjuvant therapy is not counted as a line of therapy. If recurrence occurs within 6 months after completion of adjuvant therapy, the adjuvant therapy is defined as first - line therapy. If recurrence occurs more than 6 months after completion of adjuvant therapy, the adjuvant therapy is not counted as a line of therapy.\n7. Have measurable lesions meeting Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;\n8. Subjects' baseline blood routine and biochemical indices meet the following criteria (no blood transfusion\u002Fblood products received, and no granulocyte colony - stimulating factor (G - CSF) or other hematopoietic growth factors used for correction within 14 days before the first dose):\n\n   Hemoglobin ≥ 90 g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL; Platelets ≥ 80×10\\^9\u002FL; ALT, AST ≤ 2.5 × upper limit of normal (ULN); if the patient has liver metastasis, ALT and AST ≤ 5 × ULN; Serum total bilirubin ≤ 1.5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or estimated creatinine clearance \\> 50 mL\u002Fmin (For males: Creatinine clearance = ((140 - age) × weight) \u002F (72 × serum Cr); For females: Creatinine clearance = ((140 - age) × weight) \u002F (72 × serum Cr) × 0.85; Weight unit: kg; Serum Cr unit: mg\u002FmL); Serum albumin ≥ 30 g\u002FL;\n9. No serious concurrent diseases that would result in a life expectancy of \\\u003C 5 years\n10. Female subjects of childbearing potential must undergo a serum pregnancy test within 72 hours prior to the first dose, with a negative result, and agree to use highly effective methods of contraception during treatment and for 90 days after the end of treatment. For male subjects whose partners are female of childbearing potential, they must agree to use highly effective methods of contraception during treatment and for 90 days after the end of treatment.\n11. Agree to provide blood and\u002For histological specimens.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Known HER2 positivity;\n3. Patients with adverse events from previous treatments (except alopecia) that have not resolved to ≤ Grade 1 (CTCAE v5.0);\n4. History of other malignant diseases within the past 5 years or concurrent malignant diseases, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;\n5. History of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the investigator judges that the clinical severity may hinder the signing of informed consent or affect the patient's adherence to oral medications;\n6. Clinically significant (i.e., active) heart disease that is not well-controlled, such as: (1) Symptomatic coronary heart disease; (2) New York Heart Association (NYHA) Class II or worse congestive heart failure or severe arrhythmias requiring medication intervention; (3) Myocardial infarction within the past 12 months; (4) QTc interval ≥ 450 ms in males or ≥ 470 ms in females; (5) Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n7. Arterial\u002Fvenous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc.;\n8. Clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc. If fecal occult blood is positive during screening, a re-examination is allowed; if still positive after re-examination, gastroscopy may be performed as clinically indicated (except those who have undergone gastroscopy within 3 months before enrollment to rule out such conditions);\n9. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., patients with hemophilia, coagulopathy, thrombocytopenia, etc.);\n10. Patients with upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect the absorption of oral medications; patients with a history of gastrointestinal perforation, intra-abdominal abscess, or intestinal obstruction within the past 3 months, or with imaging findings\u002Fclinical symptoms suggesting concurrent intestinal obstruction;\n11. Abnormal coagulation function (INR \\> 2.0 or prothrombin time \\> 16 seconds), with bleeding tendency or receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin, low-molecular-weight heparin, etc., is allowed);\n12. Patients with chemotherapy-induced neurotoxicity who are judged by the investigator as unsuitable for oxaliplatin use cannot be included in Intervention Arm 1; however, patients with only deep tendon reflex (DTR) loss may not be excluded;\n13. Patients who have undergone organ transplantation and require immunosuppressive therapy; patients who have used immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the first dose (e.g., \\> 10 mg\u002Fday prednisone or equivalent dose of other drugs);\n14. With active ulcers, unhealed wounds, or fractures;\n15. Patients with hypertension that cannot be well-controlled with antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);\n16. Known hypersensitivity to any investigational drugs or excipients; Urinalysis indicating urinary protein ≥ ++, with confirmed 24-hour urinary protein excretion \\> 1.0 g;\n17. Patients with clinically symptomatic serous cavity effusions (including ascites, pleural effusion, pericardial effusion) requiring symptomatic management; asymptomatic serous cavity effusion patients are allowed to enroll; patients with symptomatic serous cavity effusions that are well-controlled after active management such as drainage may be enrolled at the investigator's discretion;\n18. Active hepatitis (for hepatitis B: HBsAg positive with HBV DNA ≥ 500 IU\u002Fml; for hepatitis C: HCV antibody positive with HCV viral load \\> upper limit of normal); patients in active infection phase requiring antimicrobial therapy (e.g., antibacterial or antifungal treatment);\n19. Currently having interstitial pneumonia or interstitial lung disease, or other conditions that may interfere with the judgment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or those with active pneumonia or severe pulmonary function impairment shown by screening CT; patients with active pulmonary tuberculosis;\n20. Patients with active autoimmune diseases or a history of autoimmune diseases with potential for recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects whose condition is controllable with hormone replacement therapy may be included\\]); patients with skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia), type 1 diabetes mellitus controllable with insulin therapy, or those with a history of childhood asthma that has completely resolved without any intervention may be enrolled; asthmatic patients requiring bronchodilators for intervention cannot be enrolled.",{"count":127,"type":22},78,[81],"Immunotherapy combined with chemotherapy has become the standard first-line treatment regimen for gastric cancer. However, a subset of patients still fail to benefit or derive only limited benefit from this approach. This study aims to evaluate the addition of immunomodulatory EZH2 inhibitors or anti-angiogenic agents to the baseline regimen of immunotherapy combined with chemotherapy, in order to further improve patient treatment benefits.",[131,132],"Advanced Gastric Cancer","SHR1701","2026-04-13",{"date":135,"type":38},"2026-04-16",{"date":137,"type":38},"2025-06-15",{"date":139,"type":22},"2028-07-15",{"name":43,"class":44},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100631537","effect-of-a-novel-colonoscopic-lavage-solution-on-colonoscopy-quality-100631537","NCT07501975","Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality","Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality: A Randomized Controlled Trial Evaluating Efficacy and Safety","Inclusion Criteria:\n\n1. Age between 18 and 75 years, regardless of gender;\n2. Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);\n3. Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);\n4. Voluntarily signed informed consent and able to cooperate with completing study-related assessments.\n\nExclusion Criteria:\n\n1. Allergy to menthol, cyclodextrin, or related substances;\n2. History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);\n3. Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;\n4. Pregnant or lactating women;\n5. Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;\n6. Psychiatric disorders or cognitive impairment that prevent cooperation with the study;\n7. History of contraindications to colonoscopy or serious adverse reactions during previous procedures.",true,"75 Years",{"count":151,"type":22},498,[153],"NA","In recent years, with the continuous advancement of digestive endoscopy techniques, how to improve the adenoma detection rate (ADR) by optimizing endoscopic procedural details has become a research hotspot. Colonic spasm can lead to narrowing of the intestinal lumen, deepening of mucosal folds, and limited field of view, thereby affecting lesion exposure and reducing examination quality. Although traditional intravenous antispasmodic drugs (such as scopolamine) can alleviate intestinal spasms, they may cause side effects such as increased heart rate, blood pressure fluctuations, and other systemic adverse reactions. In contrast, menthol is a natural monoterpene compound derived from peppermint oil. It can inhibit L-type calcium channels on the cell membrane of smooth muscle through local application, thereby reducing intracellular calcium concentration and inducing smooth muscle relaxation. This helps to relieve intestinal spasms and patient discomfort during colonoscopy. On the other hand, simethicone, a commonly used defoaming agent, can reduce surface tension, eliminate foam, and improve mucosal visualization. Theoretically, combining antispasmodic menthol with defoaming simethicone may further optimize the visual field during colonoscopy and increase the ADR through a synergistic \"antispasmodic + defoaming\" mechanism. Therefore, this study plans to conduct a prospective randomized controlled trial to evaluate the antispasmodic effect, safety, and impact on the ADR of a novel irrigation solution (0.1% menthol combined with simethicone suspension) in colonoscopy, providing evidence-based medical support for optimizing endoscopic procedures.",[156],"Colonoscopy","2026-03-24",{"date":159,"type":38},"2026-03-30",{"date":161,"type":22},"2026-04-01",{"date":163,"type":22},"2026-12-31",{"name":43,"class":44},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":179,"locationsCount":4},"100631536","effect-of-intraluminal-administration-of-menthol-solution-during-colonoscopy-on-colonic-spasm-and-adenoma-detection-rate-100631536","NCT07501962","Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate","Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study",{"count":172,"type":22},440,[153],"In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol relaxes intestinal smooth muscle and alleviates spasm symptoms by antagonizing L-type calcium channels on the smooth muscle cell membrane, thereby reducing calcium influx. Furthermore, it exhibits local analgesic effects and can attenuate visceral hypersensitivity. Some studies suggest that oral or topical administration of peppermint oil preparations may improve intestinal spasm during colonoscopy, highlighting its potential utility in digestive endoscopy procedures. Nevertheless, current research on the spasmolytic efficacy and safety of menthol solution when administered via endoscopic irrigation during colonoscopy remains limited, and high-quality clinical trials are urgently needed for validation. This study aims to investigate the effectiveness and safety of menthol solution in relieving intestinal spasm, thereby providing scientific evidence for optimizing colonoscopy procedures.",[156],{"date":159,"type":38},{"date":161,"type":22},{"date":163,"type":22},{"name":43,"class":44},{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100627924","the-effect-of-blood-flow-restriction-training-combined-with-transcranial-magnetic-stimulation-on-limb-function-in-hemiplegic-patients-after-stroke-100627924","NCT07454954","The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on Limb Function in Hemiplegic Patients After Stroke","BFR-TMS-Stroke","Inclusion Criteria:\n\n* Diagnosis of stroke (ischemic or hemorrhagic) confirmed by CT or MRI, meeting the diagnostic criteria of the 4th National Cerebrovascular Disease Conference\n* First-ever stroke or recurrent stroke without residual dysfunction from prior events\n* Age 25-70 years, male or female\n* Stable vital signs, conscious, able to understand and follow therapist instructions\n* Brunnstrom stage III or above in both upper and lower limbs\n* Voluntary signed informed consent by patient or legal guardian\n\nExclusion Criteria:\n\n* Presence of cardiac pacemaker or other metal implants\n* Deafness, severe cognitive impairment, history of psychiatric disorders\n* Shoulder subluxation\n* Extensive skin damage on affected limbs\n* Severe cardiac, hepatic, pulmonary, or renal insufficiency\n* Coagulation disorders\n* Post-stroke epilepsy\n* Malignancy\n* Pregnancy or lactation","25 Years","70 Years",{"count":190,"type":22},69,[153],"This randomized controlled trial aims to evaluate whether combining blood flow restriction training (BFRT) with repetitive transcranial magnetic stimulation (rTMS) improves limb function in stroke patients with hemiplegia. A total of 69 participants will be randomly assigned to three groups: conventional rehabilitation alone (control group), conventional rehabilitation plus rTMS, or conventional rehabilitation plus BFRT combined with rTMS. The intervention period is 4 weeks, with assessments conducted at baseline and at the end of treatment. The primary outcome is the change in upper extremity Fugl-Meyer Assessment (FMA-UE) score, which measures motor function recovery. Secondary outcomes include Wolf Motor Function Test, Modified Barthel Index for daily activities, Berg Balance Scale, and safety parameters such as coagulation markers and adverse events. This study will help determine whether this combined approach offers a more effective rehabilitation strategy for stroke survivors.",[194,195],"Stroke","Hemiplegia",[194,195,197,198,199,200,201,202,203,204],"Blood Flow Restriction Training","Transcranial Magnetic Stimulation","rTMS","BFR Training","Motor Function","Rehabilitation","Upper Extremity","Randomized Controlled Trial","2026-03-05",{"date":207,"type":38},"2026-03-06",{"date":209,"type":22},"2026-03-01",{"date":211,"type":22},"2027-03-31",{"name":43,"class":44},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":230,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":241,"locationsCount":242},"100628594","clinical-outcomes-of-drug-coated-balloons-in-the-treatment-of-patients-with-coronary-de-novo-chronic-total-occlusion-lesions-100628594","NCT07463664","Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions","Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions: A Multicenter, Randomized Controlled Trial","DCB-CTO","Inclusion Criteria:\n\n* Patient voluntarily participates in the study and has provided written informed consent.\n* Presence of clinical indication for Percutaneous Coronary Intervention (PCI) of the Chronic Total Occlusion (CTO) (e.g., symptoms of angina pectoris or evidence of myocardial ischemia).\n* Target lesion is located in a de novo coronary artery.\n* Angiographically confirmed CTO (TIMI grade 0 flow), with evidence supporting an occlusion duration of ≥ 3 months.\n* Successful guidewire crossing of the target CTO lesion has been achieved during the index procedure.\n* After adequate vessel preparation: Distal TIMI grade 3 flow has been restored; Target lesion residual diameter stenosis is \\\u003C 50% (e.g., by visual estimate or QCA as per protocol); Absence of flow-limiting dissection or other complications requiring immediate stent implantation.\n* Target vessel Reference Vessel Diameter (RVD) is between 2.25 mm and 4.0 mm (inclusive, assessed by visual estimate or QCA\u002FIVUS as per protocol).\n* In the judgment of the interventional operator, the lesion is deemed suitable for treatment with both a Drug-Coated Balloon (DCB)-based strategy and a Drug-Eluting Stent (DES)-only strategy.\n* Patient is able and willing to comply with the study protocol requirements, including the specified follow-up schedule.\n* Female patients of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use an effective method of contraception throughout the study period.\n\nExclusion Criteria:\n\n* Target CTO lesion is the culprit vessel responsible for the presenting Acute Myocardial Infarction (AMI).\n* Patient is in cardiogenic shock.\n* Presence of severe heart failure (New York Heart Association \\[NYHA\\] Class IV) or Left Ventricular Ejection Fraction (LVEF) \\\u003C 30%.\n* History of stroke or Transient Ischemic Attack (TIA) within the previous 3 months.\n* Known high risk of bleeding or contraindication to Dual Antiplatelet Therapy (DAPT).\n* Presence of severe hepatic impairment and\u002For severe renal impairment (e.g., estimated Glomerular Filtration Rate \\[eGFR\\] \\\u003C 30 ml\u002Fmin\u002F1.73m² or requirement for chronic dialysis).\n* Known hypersensitivity or contraindication to required study medications (e.g., antiplatelet agents, contrast media), DCB\u002FDES drug coatings, or device materials (e.g., stent alloys, polymers).\n* Target lesion located in an unprotected left main coronary artery, a saphenous vein graft, or an arterial graft.\n* Presence of severe lesion calcification that prevents adequate vessel expansion despite attempted lesion preparation techniques (e.g., rotational atherectomy, intravascular lithotripsy).\n* Target lesion is a CTO within a previously stented segment (In-Stent Restenosis \\[ISR\\] or In-Stent Thrombosis \\[IST\\]).\n* Failed attempt at CTO recanalization during the index procedure (i.e., failure to cross the lesion with a guidewire or failure to restore TIMI grade 3 flow).\n* Occurrence of a complication after vessel preparation that necessitates immediate stent implantation (e.g., flow-limiting dissection, perforation requiring a covered stent).\n* Concurrent enrollment in another interventional clinical trial that may interfere with the study endpoints or assessments.\n* Female patient is pregnant or breastfeeding.\n* Patient judged by the investigator to be unsuitable for the study for any reason, including anticipated poor compliance with the protocol.","80 Years",{"count":223,"type":22},200,[153],"The aim of this study is to evaluate the long-term efficacy and safety of drug-coated balloon (DCB) strategies, including DCB alone or hybrid strategies of DCB and drug-eluting stent (DES), compared to DES-only in patients with chronic total occlusion (CTO) after successful recanalization. Through a prospective, multicenter randomized controlled trial, we will directly compare the long-term outcomes of these two treatment strategies in CTO patients to fill the gap in existing research regarding direct comparative data between DCB and DES in CTO treatment. This study expects to provide high-quality evidence for optimizing CTO treatment, potentially improving treatment strategies in complex cases, reducing stent usage, lowering the risk of complications, and ultimately enhancing patient prognosis.",[227,228,229],"Chronic Total Occlusions of Coronary Arteries","Chronic Total Occlusion (CTO)","Coronary Artery Disease (CAD)",[231,232,233,234,235],"drug-coated balloon","Coronary artery disease","chronic total occlusion","drug-eluting stent","clinical outcome",{"date":237,"type":38},"2026-03-11",{"date":239,"type":38},"2025-04-28",{"date":163,"type":22},{"name":43,"class":44},18,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":45},"100627261","phase-3-a-phase-iii-study-of-first-line-anlotinib-combined-with-benmelstobart-in-patients-with-advanced-esophageal-squamous-cell-carcinoma-100627261","NCT07446335","A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma","A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined With Benmelstobart Versus Toripalimab Combined With Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations","Inclusion Criteria:\n\n* (1) Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (excluding adenosquamous carcinoma); (2) No prior systemic therapy, or recurrence more than 6 months after completion of (neo)adjuvant therapy or definitive chemoradiotherapy; (3) Age: ≥18 years (calculated from the date of informed consent signature); ECOG PS score: 0-1; estimated life expectancy \\>3 months; (4) Presence of TP53 mutation or FAT1 mutation, and absence of NOTCH3 mutation; (5) At least one measurable lesion as confirmed by RECIST 1.1 criteria; measurable lesions should not have received prior local treatment such as radiotherapy (lesions within prior radiation fields may be selected as target lesions if progression is confirmed); (6) Adequate major organ function meeting the following criteria:\n* Hemoglobin ≥90 g\u002FL;\n* Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL;\n* Platelets ≥75 × 10\\^9\u002FL;\n* Total bilirubin ≤1.5 × upper limit of normal (ULN);\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if liver metastases present);\n* Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin;\n* Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤1.5 × ULN (for patients not receiving anticoagulation);\n* Thyroid-stimulating hormone (TSH) ≤ULN (if TSH abnormal, normal free T3 and free T4 are acceptable); (7) Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with negative serum or urine pregnancy test within 7 days prior to enrollment; men must agree to use effective contraception during the study and for 6 months after study completion, see Section 5.4 for details; (8) Voluntary participation in this study with signed informed consent and good compliance.\n\nExclusion Criteria:\n\n* (1) Other malignancies within 3 years prior to first dose or currently concurrent malignancies, except:Other malignancies treated with surgery alone with continuous disease-free survival (DFS) of ≥5 years;Cured cervical carcinoma in situ, non-melanomatous skin cancer, and superficial bladder tumors \\[Ta (non-invasive), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)\\]; (2) Conditions affecting intravenous injection or blood collection, or factors affecting oral drug administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction); (3) Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except Grade 2 alopecia, Grade 2 peripheral neuropathy, Grade 2 anemia, clinically non-significant and asymptomatic laboratory abnormalities, and hypothyroidism stable on hormone replacement therapy judged by investigator as having no safety risk; (4) Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment (except protocol-required surgery), or presence of non-healing wounds or fractures. \\[Major surgery defined as Grade 3 or higher per National Surgical Classification Directory 2022\\]; (5) Esophageal squamous cell carcinoma with active bleeding from primary lesion within 2 months; hematemesis or melena with daily blood loss ≥2.5 mL within 3 months prior to screening, or any bleeding event ≥CTCAE Grade 3, or any bleeding signs or history regardless of severity judged by investigator as unsuitable for enrollment; (6) Arterial or venous thrombotic events within 6 months prior to first dose, including cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism; (7) Active viral hepatitis with inadequate control. Eligible if: HBsAg-positive subjects: HBV DNA \\\u003C2000 IU\u002FmL (or 1×10⁴ copies\u002FmL) or receiving anti-HBV treatment for ≥1 week prior to study with ≥1 log reduction in viral load, with willingness to continue anti-HBV therapy throughout study; HCV-infected subjects (HCV Ab or HCV RNA positive): judged by investigator as stable or receiving approved antiviral treatment at enrollment with plan to continue; (8) Active syphilis infection requiring treatment; (9) Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis requiring treatment, or symptomatic active pneumonia; (10) History of psychoactive substance abuse with inability to abstain, or psychiatric disorder; (11) Prior or planned allogeneic bone marrow or solid organ transplantation; (12) History of hepatic encephalopathy; (13) Significant cardiovascular disease, including any of the following:\n\n  1. New York Heart Association (NYHA) Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C50% by echocardiography;\n  2. History of clinically significant ventricular arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmia requiring continuous antiarrhythmic medication;\n  3. Unstable angina pectoris;\n  4. Myocardial infarction within 12 months;\n  5. Fridericia-corrected QT interval (QTcF) \\>450 msec for males or \\>470 msec for females (if abnormal, three consecutive measurements ≥2 minutes apart, use average);\n  6. Congenital long QT syndrome or family history;\n  7. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to randomization (implanted port or catheter-related thrombosis, or superficial venous thrombosis not considered \"serious\");\n  8. Current use or recent use (within 7 days prior to study treatment) of aspirin (\\>325 mg\u002Fday), dipyridamole, ticlopidine, clopidogrel, or cilostazol; (14) Active or uncontrolled severe infection (≥CTCAE Grade 2); (15) Renal failure requiring hemodialysis or peritoneal dialysis; (16) History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disorders; (17) Use of immunosuppressants or systemic or absorbable topical corticosteroids for immunosuppressive purposes within 7 days prior to first dose (except prednisone ≤10 mg daily or equivalent); (18) Epilepsy requiring treatment; (19) Tumor-related symptoms and treatment:\n\n  \u003C!-- -->\n\n  1. Cytotoxic chemotherapy, immunotherapy within 3 weeks, or radiotherapy or small molecule targeted therapy within 2 weeks prior to first dose, or within 5 half-lives of drug (whichever is shorter) from last treatment; (prior radiotherapy: target lesions should not be within radiation field, or if within field, progression must be confirmed);\n  2. Traditional Chinese medicines with anti-tumor indications approved by NMPA within 2 weeks prior to first dose (including Compound Cantharis Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Brucea Javanica Oil Injection\u002FCapsules, Xiaoaiping Tablets\u002FInjection, Huachansu Capsules, etc.);\n  3. Imaging evidence of significant tumor invasion into adjacent organs (aorta or trachea) with increased risk of bleeding or fistula; ulcerative ESCC with increased bleeding risk due to proximity to vessels;\n  4. Known complete esophageal obstruction requiring interventional relief;\n  5. Post-esophageal or tracheal stent placement;\n  6. Uncontrolled pleural effusion, pericardial effusion, or moderate to severe ascites requiring repeated drainage (investigator judgment);\n  7. Known spinal cord compression, carcinomatous meningitis, or brain metastasis with symptoms or symptom control \\\u003C4 weeks; (20) Known hypersensitivity to study drug excipients; (21) Prior treatment with anlotinib hydrochloride or other anti-angiogenic agents, or any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody; (22) Participation in other interventional clinical trials with investigational drug use within 4 weeks prior to first dose; (23) Pregnancy, lactation, or planned pregnancy during study period; (24) Any condition that, in the opinion of the investigator, would pose significant safety risk to the subject or interfere with completion of the study.",{"count":251,"type":22},578,[25],"A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined with Benmelstobart versus Toripalimab Combined with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations",[255],"Advanced Esophageal Squamous Cell Carcinoma","2026-02-26",{"date":258,"type":38},"2026-03-03",{"date":260,"type":22},"2026-04",{"date":262,"type":22},"2029-06",{"name":43,"class":44},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":45},"100620774","phase-1-ibi363-plus-bevacizumab-with-or-without-nab-paclitaxel-for-second-line-treatment-of-advanced-gastric-cancer-100620774","NCT07361991","IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer","A Phase Ib\u002FII Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Bevacizumab With or Without Nab-Paclitaxel as Second-Line Therapy in Patients With Advanced Gastric Cancer","Inclusion Criteria\n\n1. Signed informed consent: The patient must voluntarily sign a written informed consent form and be able to comply with the visit schedule and procedures specified in the protocol.\n2. Age: 18 to 75 years (inclusive), male or female.\n3. Diagnosis and prior therapy:\n\n   \\* Histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma (GC or GEJC).\n   * Disease progression or intolerance after prior first-line systemic antitumor therapy including immunotherapy.\n   * Primary immune resistance: best response during immunotherapy is stable disease (SD) lasting \\\u003C 12 weeks, or progressive disease (PD).\n   * Acquired immune resistance:\n\n1\\. For patients with PD on immunotherapy: best response during treatment is complete response (CR), partial response (PR), or SD lasting ≥ 12 weeks; 2. For patients who discontinued immunotherapy for reasons other than disease progression and subsequently developed PD: best response during treatment is CR, PR, or SD lasting ≥ 12 weeks, and the interval between last immunotherapy dose and PD is ≤ 6 months.\n\n4\\. Baseline hematology (within 7 days before first dose of study drug) must meet all of the following:\n\n* Hemoglobin ≥ 90 g\u002FL;\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n* Platelet count ≥ 100 × 10⁹\u002FL;\n* Eosinophils \\\u003C 1.5 × upper limit of normal (ULN).\n\n\\*In this protocol, \"baseline\" is defined as the last available assessment prior to the first dose of study drug. Within 7 days before blood sampling, patients must not receive blood products (including packed red blood cells, apheresis platelets, cryoprecipitate, etc.), erythropoiesis-stimulating agents, or colony-stimulating factor support.\\*\n\n5\\. Baseline serum chemistry (within 7 days before first dose) must meet all of the following:\n\n* Total bilirubin ≤ 1.5 × ULN (patients with total bilirubin \\> 1.5 × ULN are allowed if conjugated bilirubin ≤ ULN);\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN;\n* Serum creatinine ≤ 1.5 × ULN \\*\\*or\\*\\* creatinine clearance (CCr) ≥ 45 mL\u002Fmin, calculated by the Cockcroft-Gault formula using actual body weight;\n* Serum albumin ≥ 32 g\u002FL.\n\n  6\\. Baseline coagulation function (within 7 days before first dose) must meet all of the following:\n* International normalized ratio (INR) ≤ 1.5 × ULN (≤ 3 × ULN if on stable anticoagulation therapy);\n* Partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (≤ 3 × ULN if on stable anticoagulation therapy).\n\n  7\\. Baseline urinalysis (within 7 days before first dose)must meet one of the following:\n* Urine protein (UPRO) \\\u003C 2+ by dipstick, \\*\\*or\\*\\*\n* 24-hour urine protein \\\u003C 1 g.\n\n  8\\. At least one measurable lesion as defined by RECIST v1.1 for solid tumors.\n\n  9\\. ECOG performance status of 0 or 1 (Eastern Cooperative Oncology Group).\n\n  10\\. Estimated life expectancy ≥ 3 months.\n\n  11\\. Contraception: Women of childbearing potential and men whose partners are women of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the last dose of study treatment.\n\nExclusion Criteria\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant before the first dose of study drug, during study treatment, or within 6 months after the last dose.\n2. History of active thrombosis, deep venous thrombosis, or pulmonary embolism within 4 weeks before the first dose of study drug, unless adequately treated and considered clinically stable by the investigator.\n3. Clinically significant cardiovascular or cerebrovascular disease, including but not limited to:\n\n   \\* Ventricular arrhythmias or other uncontrolled arrhythmias requiring medical intervention (e.g., anti-arrhythmic therapy);\n\n   \\* Severe conduction abnormalities (e.g., third-degree atrioventricular block);\n\n   \\* QT interval corrected by Fridericia (QTcF) ≥ 480 ms;\n\n   \\* Uncontrolled arterial hypertension despite optimal medical therapy (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);\n\n   \\* History of myocarditis;\n\n   \\* Current congestive heart failure requiring treatment;\n\n   \\* Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n   \\* New York Heart Association (NYHA) class III or IV heart failure;\n\n   \\* Acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent implantation within 6 months prior to the first dose;\n\n   \\* Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose;\n\n   \\* Known active seizure disorders.\n4. Interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, or other forms of restrictive lung disease that require corticosteroids or other treatment, or a history of severely impaired pulmonary function.\n5. History of atopic constitution, asthma, or atopic dermatitis.\n6. Clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated drainage or associated with significant symptoms.\n7. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose of study drug. Replacement therapy (e.g., thyroxine, insulin, or physiological replacement doses of corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.\n8. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n9. Known hypersensitivity or allergy to study drugs or any of their excipients.\n10. History of significant toxicities related to prior immune checkpoint inhibitor therapy that required permanent discontinuation of that treatment.\n11. Unresolved toxicities from prior antitumor therapies \\> Grade 1 (based on NCI CTCAE), with the exception of the following: persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, or other toxicities that are expected to be irreversible but are stable under medical management (e.g., hypothyroidism controlled with replacement therapy, hypertension controlled to \\\u003C160\u002F100 mmHg with antihypertensive medications).\n12. Incomplete recovery from prior surgery, or having undergone any major surgery within 4 weeks before the first dose of study drug.\n13. Active, uncontrolled bleeding or known bleeding diathesis.\n14. Major gastrointestinal diseases or conditions within 6 months prior to the first dose, including:\n\n    \\* History of inflammatory bowel disease;\n\n    \\* ≥ Grade 2 diarrhea occurring within 2 weeks before the first dose;\n\n    \\* Radiation enteritis.\n15. Uncontrolled tumor-related pain or symptomatic hypercalcemia at screening.\n16. Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis.\n\n    * Patients who are HBsAg-positive and\u002For hepatitis B core antibody (HBcAb)-positive must have HBV DNA testing. Patients with HBV DNA ≤ 2.5 × 10³ copies\u002FmL or ≤ 500 IU\u002FmL or below the lower limit of detection may be enrolled. HBsAg-positive patients should receive antiviral therapy against HBV throughout study treatment to prevent viral reactivation.\n    * Patients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have undetectable HBV viral load do not require prophylactic antiviral treatment but must be closely monitored for HBV reactivation.\n    * Patients with positive HCV serology but negative HCV RNA or HCV RNA below the lower limit of detection may be enrolled.\n    * Patients who have completed HCV treatment and have undetectable viral load may be enrolled.\n17. Severe or uncontrolled infection, infection requiring systemic intravenous antibiotics, or fever of unknown origin \\> 38°C within 2 weeks prior to the first dose of study drug.\n18. Any other malignancy diagnosed within 5 years before the first dose of study drug, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ that has been completely resected, and localized prostate cancer or papillary thyroid carcinoma that has been cured by radical surgery.\n19. \\*\\*Prohibited medications and treatments\\*\\* (patients must not receive any of the following):\n\n1\\) IL-2\u002FIL-15-based cytokine therapies. Use of IL-2\u002FIL-15 as a component of adoptive cell therapy or as immune modulation in immunocompromised patients is allowed.\n\n2\\) Any chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug, without delayed toxicities, with the exception of:\n\n* Use of nitrosourea agents or mitomycin C within 6 weeks prior to the first dose is prohibited.\n\n  3\\) Any antibody therapy within 4 weeks prior to the first dose of study drug; 4) Participation in any interventional clinical trial involving medical devices or other therapeutic interventions within 2 weeks prior to the first dose; 5) Palliative radiotherapy within 2 weeks prior to the first dose; 6) Live vaccines for prevention of infectious diseases within 4 weeks prior to the first dose; 7) Immunosuppressive or systemic corticosteroid therapy (\\> 10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to the first dose of study drug; 8) Traditional Chinese medicines with definite antitumor effects within 1 week prior to the first dose.\n\n  20\\. History of significant toxicities related to prior paclitaxel therapy that required permanent discontinuation of that treatment, or any contraindications to study drugs that, in the opinion of the investigator, preclude safe administration of the study treatment.\n\n  21\\. Any disease, treatment, laboratory abnormality, or history of drug abuse which, in the opinion of the investigator, may compromise patient safety, interfere with informed consent, affect patient compliance, or interfere with the evaluation of the safety of the study drug.\n\n  22\\. Psychiatric illness, altered mental status, or history of substance abuse that may interfere with the patient's ability to understand the informed consent process and\u002For complete required study assessments.\n\n  23\\. Any other condition that, based on known or foreseeable circumstances, in the investigator's judgment would make the patient unable to comply with the protocol requirements.",{"count":5,"type":22},[80,81],"This study is for patients with advanced or metastatic gastric cancer whose disease has worsened after first-line systemic therapy. IBI363 is an investigational antibody that may help the immune system recognize and attack cancer cells. This trial will evaluate IBI363 in combination with bevacizumab, with or without nab-paclitaxel, as a second-line treatment.\n\nThe study has two parts. In the phase Ib part, small groups of patients will receive IBI363 plus bevacizumab with or without nab-paclitaxel to evaluate the safety, side effects, and tolerability of the combination and to determine an appropriate dose for further study. In the phase II part, additional patients will receive the selected regimen to assess the preliminary antitumor activity of IBI363 in combination with bevacizumab ± nab-paclitaxel, including tumor response and other clinical outcomes, as well as to further describe the safety profile. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons defined in the protocol.",[275,276],"Advan'ce'd","Advanced","2026-01-21",{"date":279,"type":38},"2026-01-23",{"date":281,"type":22},"2026-03",{"date":283,"type":22},"2030-09",{"name":43,"class":44},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":291,"minAge":19,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":45},"100617130","phase-2-prospective-multicenter-single-arm-phase--clinical-study-on-the-efficacy-and-safety-of-sacituzumab-tirumotecan-combined-with-bevacizumab-in-platinum-resistant-recurrent-ovarian-cancer-100617130","NCT07314619","Prospective, Multicenter, Single-Arm, Phase Ⅱ Clinical Study on the Efficacy and Safety of Sacituzumab Tirumotecan Combined With Bevacizumab in Platinum-Resistant Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* 1.Sign a written informed consent form before undergoing any trial-related procedures;\n* 2.Female, aged ≥ 18 years;\n* 3.Histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; with platinum resistance (recurrence within 6 months after the last platinum dose);\n* 4.Enrolled subjects must have received at least one but no more than three prior systemic treatment regimens, and the prior regimens may include bevacizumab and\u002For poly(ADP-ribose) polymerase inhibitors (PARPi);\n* 5.For subjects with brain metastases, only those with asymptomatic or symptomatically stable brain metastases are eligible for enrollment;\n* 6.ECOG performance status score of 0-1;\n* 7.Expected survival time \\> 6 months;\n* 8.Adequate organ function, with subjects required to meet the following laboratory parameters:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL without the use of granulocyte colony-stimulating factor (G-CSF) within the past 14 days;\n  2. Platelet count ≥ 100×10⁹\u002FL without blood transfusion within the past 14 days;\n  3. Hemoglobin \\> 9 g\u002FdL without blood transfusion or use of erythropoietin within the past 14 days;\n  4. Total bilirubin ≤ 1.5×Upper Limit of Normal (ULN);\n  5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN;\n  6. Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n  7. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5×ULN;\n  8. Normal thyroid function, defined as Thyroid-Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may still be enrolled if their total triiodothyronine (T3) (or free triiodothyronine, FT3) and free thyroxine (FT4) are within the normal range;\n  9. Cardiac enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator may also be enrolled);\n* 9.For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women who are not of childbearing potential are defined as those who are postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;\n* 10.For female subjects with fertility potential, they must agree to use effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* 1.Diagnosis of other malignant diseases within 5 years before the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ with radical resection);\n* 2.Known presence of active bleeding signs in lesions as shown by endoscopy;\n* 3.Currently participating in therapeutic intervention clinical research, or having received other study drugs or treatment with study devices within 4 weeks before the first dose;\n* 4.Previous receipt of the following therapies: ADC drugs targeting FR-α, or TROP2-targeted treatments (such as any drug therapy containing topoisomerase I targeting agents, including antibody-drug conjugate (ADC) therapy);\n* 5.Systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose;\n* 6.Occurrence of active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment;\n* 7.Receipt of systemic glucocorticoid therapy (excluding nasal spray, inhaled, or other forms of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Use of physiological doses of glucocorticoids (≤ 10 mg\u002Fday of prednisone or equivalent) is permitted;\n* 8.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* 9.Known hypersensitivity to the drugs used in this study;\n* 10.Failure to fully recover from toxicity and\u002For complications caused by any intervention (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia) before the start of treatment;\n* 11.Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1\u002F2 antibodies);\n* 12.Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number exceeding the upper limit of normal of the laboratory in the research center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled: a) HBV viral load \\\u003C 1000 copies\u002Fml (200 IU\u002Fml) before the first dose, and subjects should receive anti-HBV treatment throughout the study chemotherapy period to prevent viral reactivation; b) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary;\n* 13.Subjects with active HCV infection (positive HCV antibodies and HCV-RNA level above the lower limit of detection);\n* 14.Receipt of live vaccines within 30 days before the first dose (Cycle 1, Day 1); Note: Receipt of inactivated viral vaccines for seasonal influenza via injection within 30 days before the first dose is permitted; however, intranasal attenuated live influenza vaccines are not allowed;\n* 15.Pregnant or lactating women;\n* 16.Presence of any severe or uncontrollable systemic diseases, such as:\n\n  1. Significant and severely symptomatic, uncontrollable abnormalities in resting electrocardiogram (ECG) in terms of rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation;\n  2. Unstable angina pectoris, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) classification ≥ Grade 2;\n  3. Any arterial thrombosis, embolism, or ischemia (e.g., myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack) occurring within 6 months before enrollment;\n  4. Poorly controlled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg);\n  5. History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose, or current clinically active interstitial lung disease;\n  6. Active pulmonary tuberculosis;\n  7. Presence of active or uncontrolled infection requiring systemic treatment;\n  8. Presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;\n  9. Liver diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. Poorly controlled diabetes mellitus (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n  11. Urinalysis indicating urine protein ≥ ++, and confirmed 24-hour urine protein quantification \\> 1.0 g;\n  12. Patients with mental disorders who are unable to cooperate with treatment;\n* 17.Need for use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks before the first dose and during the study period (use of strong CYP3A4 inhibitors or inducers is not permitted in this study; all subjects must avoid concurrent use of any drugs, herbal supplements, and\u002For ingestion of such foods known to induce CYP3A4 as much as possible);\n* 18.Documented history of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal disease that impairs delayed corneal wound healing;\n* 19.History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current presence of ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia at screening that cannot be excluded by imaging examination;\n* 20.Evidence of medical history, disease, treatment, or abnormal laboratory test results that may interfere with study results, prevent the subject from completing the study, or other circumstances deemed unsuitable for enrollment by the investigator (including other potential risks considered by the investigator that make the subject unfit for participation in this study).","FEMALE",{"count":293,"type":22},30,[81],"As one of the gynecological malignancies with the highest incidence and mortality rates worldwide, ovarian cancer treatment faces the significant challenge of platinum-resistant recurrence. Patients with platinum-resistant recurrent ovarian cancer (PROC) have an extremely poor prognosis, and the survival benefits of traditional chemotherapy and bevacizumab combination therapy are limited (median progression-free survival \\[mPFS\\] is approximately 2-5 months, and 5-year survival rate is 30%-40%). In recent years, the antibody-drug conjugate (ADC) Sacituzumab tirumotecan has shown breakthrough potential. A phase Ⅱ study presented at the 2024 European Society for Medical Oncology (ESMO) Congress demonstrated that for patients with advanced platinum-resistant ovarian cancer (87.5% of whom had platinum resistance) treated with this drug as monotherapy, the objective response rate (ORR) reached 40%, median progression-free survival (mPFS) was 6.0 months, and disease control rate (DCR) was 75%. Furthermore, the ORR increased to 61.5% in patients with high Trop2 expression, and the safety profile was manageable.Based on the preclinical model evidence suggesting that anti-angiogenic drugs can enhance the intratumoral penetration of ADCs, the current study further explores the synergistic effect of Sacituzumab tirumotecan combined with bevacizumab. It aims to improve therapeutic efficacy by optimizing tumor microcirculation and analyze the molecular mechanisms using technologies such as organoids and single-cell sequencing, thereby providing a new strategy to overcome the bottleneck of platinum resistance.",[297],"Platinum-resistant Recurrent Ovarian Cancer (PROC)","2025-12-18",{"date":300,"type":38},"2026-01-02",{"date":302,"type":22},"2025-12-30",{"date":304,"type":22},"2027-12-30",{"name":43,"class":44},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},"100605985","observation-study-on-reducing-the-risk-of-liver-cancer-associated-with-hepatitis-b-zhiyuan-project-100605985","NCT07169656","Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.","Inclusion Criteria:\n\n* 1.Chronic HBV infection (HBsAg-positive for ≥6 months); 2.Age ≥18 years; 3.Patients who, based on real-world clinical practice needs, are planned or currently receiving treatment with:Entecavir (ETV),Tenofovir disoproxil fumarate (TDF),Tenofovir alafenamide fumarate (TAF),Tenofovir amibufenamide (TMF) OR Pegylated interferon α-2b-naïve patients OR Patients re-initiating pegylated interferon α-2b therapy; 4.Written informed consent obtained from the patient.\n\nExclusion Criteria:\n\n* 1.Severe hepatic dysfunction or decompensated cirrhosis; 2.Concurrent participation in other clinical trials; 3.Hepatocellular carcinoma (HCC).",{"count":313,"type":22},15000,"This study is a multicenter, prospective, observational real-world study designed to investigate and analyze the current treatment patterns of chronic hepatitis B (CHB) across 200 hospitals in China. By comparing patient outcomes under different therapeutic regimens, it aims to provide high-quality evidence-based medical data to optimize CHB treatment strategies and follow-up protocols, ultimately contributing to the advancement of a functional cure for chronic hepatitis B.",[316],"Chronic Hepatitis b","2025-09-09",{"date":319,"type":38},"2025-09-12",{"date":321,"type":38},"2024-06-03",{"date":323,"type":22},"2032-12-31",{"name":43,"class":44},162,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":4},"100602836","phase-2-a-single-center-multicohort-phase-ii-clinical-study-evaluating-the-combination-therapy-of-sacituzumab-tirumotecan-in-patients-with-unresectable-locally-advanced-recurrent-or-metastatic-esophageal-squamous-cell-carcinoma-100602836","NCT07128693","A Single-center, Multicohort, Phase II Clinical Study Evaluating the Combination Therapy of Sacituzumab Tirumotecan in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of informed consent signing.\n2. Diagnosed as unresectable locally advanced\u002Frecurrent or metastatic esophageal squamous cell carcinoma by histology\u002Fpathology.\n3. Cohort 1: Have never received any anti-tumor systemic treatment before, including but not limited to immunotherapy, targeted therapy, chemotherapy, etc. Cohort 2: Patients who have experienced progression or intolerance after receiving first-line systemic chemotherapy or chemotherapy combined with immunotherapy (which may include regimens based on platinum, taxanes or fluorouracil) (patients with progression after maintenance treatment following first-line chemotherapy can also be included).\n4. For patients with brain metastases, those who are asymptomatic or have stable symptoms of brain metastases are eligible for enrollment.\n5. The provision of tissue specimens is not mandatory. Patients can still be enrolled if there is no tissue specimen available.\n6. According to RECIST v1.1, the investigator should assess that there is at least one measurable target lesion that has not been irradiated.\n7. ECOG performance status score of 0 or 1.\n8. Expected survival time ≥ 12 weeks.\n9. Adequate organ and bone marrow function(with no receipt of blood transfusions, recombinant human thrombopoietin, or colony-stimulating factors within two weeks prior to first drug administration), defined as follows:\n\n   1. Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109\u002FL; Platelet (PLT) ≥100×109\u002FL; Hemoglobin ≥ 90g\u002FL.\n   2. Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 times ULN;\n   3. Renal function: Ccr ≥ 60 ml\u002Fmin (Cockcroft-Gault formula provided).\n   4. International Normalized Ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) values are ≤ 1.5 times the upper limit of normal (ULN).\n10. For female subjects of childbearing potential and male subjects with reproductive potential, a commitment to effective medical contraception is required from the date of informed consent signing through 6 months after the last dose administration.\n11. The subjects voluntarily joined this study, signed the informed consent form, and were able to comply with the visit and related procedures as stipulated in the protocol.\n\nExclusion Criteria:\n\n1. Having participated in other drug clinical trials within 4 weeks before enrollment.\n2. Cohort 1: Having previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.\n3. Cohort 2: Having previously received anlotinib or other anti-angiogenic drugs; patients with tumor invasion of large blood vessels shown by imaging, or those judged to be highly likely to have tumors invading important blood vessels during the subsequent study period, leading to fatal massive bleeding; patients with bleeding tendencies such as acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation dysfunction.\n4. Patients with multiple factors affecting oral drug administration (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).\n5. Prior treatment with TROP2-targeted therapy and\u002For topoisomerase I inhibitors.\n6. A history of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.\n7. Known history of allergy to the drugs in this protocol and their components.\n8. Positive for human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n9. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n10. Vaccinated with live vaccine within 30 days before the first study drug administration.\n11. 7.A history of interstitial lung disease (ILD) or non-infectious pneumonia requiring corticosteroid therapy, or current ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia at screening that cannot be ruled out by imaging; clinically significant pulmonary impairment due to concurrent lung conditions, including but not limited to underlying pulmonary disorders (e.g., pulmonary embolism within 3 months prior to study entry, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion), autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), or prior pneumonectomy.\n12. Active autoimmune diseases requiring systemic therapy within the past two years (hormone replacement therapy is excluded from systemic treatment, including conditions such as type 1 diabetes, hypothyroidism managed with thyroid hormone replacement alone, and adrenal or pituitary insufficiency treated solely with physiological doses of glucocorticoid replacement therapy).\n13. Active infections requiring systemic treatment within 2 weeks prior to the first dose administration.\n14. Concomitant diseases that, in the investigator's judgment, pose a significant risk to patient safety or may interfere with study completion, including but not limited to medication-uncontrolled hypertension, severe diabetes, or active infections.\n15. A documented history of severe dry eye syndrome, severe meibomian gland dysfunction and\u002For blepharitis, or corneal disorders associated with delayed corneal healing.\n16. Female patients who are pregnant, lactating, or of childbearing potential with a positive baseline pregnancy test; female patients of childbearing age who are unwilling to adopt effective contraceptive measures during the treatment with the study drug and within 6 months after the last dose.\n17. Any other circumstances deemed by the investigator to make the patient unsuitable for participation in this study.",{"count":333,"type":22},60,[81],"The aim of this study is to evaluate the efficacy and safety of the combined treatment with Sacituzumab Tirumotecan in patients with unresectable locally advanced\u002Frecurrent or metastatic esophageal squamous cell carcinoma.",[337],"Esophageal Squamous Cell Carcinoma","2025-08-14",{"date":340,"type":38},"2025-08-19",{"date":342,"type":22},"2025-09",{"date":344,"type":22},"2028-12",{"name":43,"class":44},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":45},"100584981","phase-1-randomized-trial-of-glutathione-with-anti-pd-1-and-chemotherapy-in-advanced-nsclc-100584981","NCT06896422","Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC","Prospective, Randomized Controlled Clinical Trial of Glutathione Combined With PD-1 Antibody and Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of lung squamous cell carcinoma or adenocarcinoma.\n2. Documented disease progression following first-line chemotherapy or chemo-immunotherapy.\n3. Age ≥18 years at the time of enrollment.\n\nExclusion Criteria:\n\n1. Patients with small cell lung cancer or other histological subtypes of lung cancer.\n2. Patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis.\n3. Pregnant or lactating women",{"count":354,"type":22},80,[80],"Chemotherapeutic agents exert significant immunomodulatory effects by influencing tumor-infiltrating immune cells. However, the sequence and combination of chemotherapy regimens differentially modulate immune cell dynamics, ultimately impacting treatment efficacy and patient survival. Glutathione, a critical bioactive molecule, demonstrates broad potential in tumor immunotherapy. Through mechanisms such as scavenging free radicals, modulating immune cell proliferation and differentiation, and regulating cytokine expression, glutathione achieves precise modulation of immune responses to enhance immune system functionality. To investigate whether glutathione can enhance the clinical efficacy of current chemo-immunotherapy regimens in non-small cell lung cancer (NSCLC), investigators conducted this clinical study.",[358,359,360,361],"Non-Small Cell Lung Cancer","Chemotherapy","PD1 Antibody","Glutathione","2025-08-06",{"date":364,"type":38},"2025-08-07",{"date":366,"type":38},"2025-06-01",{"date":368,"type":22},"2027-12-31",{"name":43,"class":44},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":291,"minAge":19,"maxAge":149,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":45},"100600950","phase-2-neoadjuvant-chemotherapy-plus-cadonilimab-for-locally-advanced-cervical-cancer-100600950","NCT07104149","Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer","Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2 Trial","Histologically confirmed cervical carcinoma, FIGO stage IB3, IIA2, IIB, IIIC1, and assessed as resectable by the researcher。\n\nInclusion Criteria:\n\n* Female, age ≥18 years;\n* Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, and assessed by the researcher as resectable;\n* No previous systemic treatment for the current disease, including surgical treatment, antitumor chemoradiotherapy\u002Fimmunotherapy, etc.;\n* Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no surgical contraindications;\n* ECOG score of 0-1;\n* Expected survival time \\>6 months;\n* Sufficient organ function, the subject must meet the following laboratory indicators:\n\nNeutrophil absolute count (ANC) ≥1.5x10\\^9\u002FL ; Platelets ≥100x10\\^9\u002FL ;Hemoglobin \\>9g\u002FdL ; Total bilirubin ≤1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml\u002Fmin; international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; Normal thyroid function; Myocardial enzymes within the normal range\n\nExclusion Criteria:\n\n* Diagnosis of other malignancies within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone radical resection).\n* Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.\n* Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors .\n* Systemic treatment with Chinese herbal medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal\u002Fpituitary insufficiency) are not considered systemic treatment.\n* Systemic glucocorticoid therapy (excluding nasal sprays, inhalations, or other local routes) or any immunosuppressive therapy within 7 days prior to the first dose.\n* History of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.\n* Known hypersensitivity to any study drug.\n* Presence of multiple factors affecting cisplatin use (e.g., platinum allergy).\n* Inadequate recovery from prior intervention-related toxicity or complications (i.e., \\>Grade 1 or not returned to baseline, excluding fatigue or alopecia).\n* Known history of Human Immunodeficiency Virus（ HIV） infection .\n* Untreated active hepatitis B （HBV）(defined as HBsAg-positive with HBV-DNA exceeding the upper limit of normal at the study site).\n* Active hepatitisC (HCV) infection (HCV antibody-positive with HCV-RNA above the lower detection limit).\n* Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).\n* Pregnant or lactating women.\n* Severe or uncontrolled systemic diseases, including:Symptomatic resting Electrocardiograph abnormalities (e.g., complete left bundle branch block, ≥Grade II heart block, ventricular arrhythmia, atrial fibrillation).Unstable angina, congestive heart failure, or chronic heart failure ≥NYHA class II.Arterial thromboembolism, ischemia, myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.Poorly controlled hypertension (systolic \\>140 mmHg, diastolic \\>90 mmHg).History of non-infectious pneumonitis requiring glucocorticoids within 1 year or current active interstitial lung disease.\n* Active tuberculosis.\n* Active or uncontrolled infection requiring systemic therapy.\n* Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.\n* Liver diseases (e.g., cirrhosis, decompensated liver disease, acute\u002Fchronic active hepatitis).\n* Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL).\n* Urine protein ≥++ on urinalysis with 24-hour urine protein \\>1.0 g.\n* Psychiatric disorders impairing compliance.\n* Any condition (e.g., medical history, abnormal lab\u002Ftest results, concurrent treatments) that may interfere with study outcomes, participation, or pose risks, as judged by the investigator.",{"count":78,"type":22},[81],"Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.\n\nThis is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg\u002Fkg, iv., D1, q3w）with Cisplatin ( 75mg\u002F m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.",[381,382,383,384,385,386,387,388,389],"Female, Age ≥ 18 Years Old","No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy\u002FImmunotherapy","ECOG Score of 0-1","Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion","Sufficient Organ Function","The Result of the Urine or Serum Pregnancy Test for the Subject is Negative","Subjects Should Take Contraceptive Measures","Locally Advanced Cervical Cancer","Expected Survival Time >6 Months","2025-08-01",{"date":392,"type":38},"2025-08-05",{"date":394,"type":38},"2025-03-10",{"date":396,"type":22},"2027-06-30",{"name":43,"class":44},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":417,"locationsCount":4},"100599498","phase-2-irinotecan-liposome-ii--5-fulv--oxaliplatin--karelizumab-in-neoadjuvant-treatment-of-gastric-cancer-100599498","NCT07085273","Irinotecan Liposome II + 5-FU\u002FLV + Oxaliplatin + Karelizumab in Neoadjuvant Treatment of Gastric Cancer","A Single-arm Clinical Study of Irinotecan Liposome II + 5-FU\u002FLV + Oxaliplatin + Karelizumab for Neoadjuvant Treatment of Gastric Cancer","Inclusion Criteria:\n\n1. age ≥ 18 years and ≤ 75 years;\n2. gastric cancer confirmed by histopathology or cytology;\n3. critically resectable gastric cancer confirmed by imaging;\n4. at least one measurable lesion (according to RECIST v1.1);\n5. ECOG score of 0 to 2;\n6. expected survival time ≥ 3 months;\n7. UGTA1\\*1\\*28 and UGTA1\\*1\\*6 genes tested wild-type;\n8. bone marrow function: neutrophils (ANC) ≥1.5×10\\^9\u002FL, platelets (PLT) ≥100×10\\^9\u002FL, hemoglobin (Hb) ≥90g\u002FL, white blood cells (WBC) ≥3.0×10\\^9\u002FL;\n9. Liver function: alanine aminotransferase (ALT), alanine transaminase (AST), alkaline phosphatase (ALP) ≤2.5×ULN (upper limit of normal), ≤5×ULN in case of liver metastasis; total bilirubin ≤1.5×ULN;\n10. renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml\u002Fmin (calculated according to Cockroft-Gault), urine protein \\\u003C2+;\n11. coagulation: international normalized ratio (INR) ≤ 1.5 times upper limit of normal (ULN) and activated partial thromboplastin time (APTT) ≤ 1.5 times upper limit of normal (ULN);\n12. be able to understand the circumstances of this study, and the patient and\u002For legal representative voluntarily agree to participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);\n2. prior irinotecan\u002Firinotecan liposome-based chemotherapy;\n3. large pleural effusions or ascites requiring intervention;\n4. active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy\n5. known active HIV infection; untreated active HBV and HCV infection\n6. a combination of uncontrolled systemic diseases, including cardiovascular diseases such as unstable angina pectoris, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, and a history of severe pericardial disease; uncontrollable hypertension (defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg after regulated antihypertensive medication) or a history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes; and controlled diabetes mellitus, etc;\n7. the presence of severe gastrointestinal-like illness (including active bleeding, greater than grade 1 obstruction, greater than grade 1 diarrhea, or gastrointestinal perforation)\n8. history of cesarean section, open thoracic surgery or bowel resection within 28 days prior to enrollment;\n9. presence of interstitial pneumonia or pulmonary fibrosis;\n10. known hypersensitivity or intolerance to therapeutic drugs or their excipients;\n11. history of pulmonary hemorrhage\u002Fcoughing up ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to enrollment;\n12. presence of arterial embolism, severe hemorrhage (other than hemorrhage due to surgery), or a predisposition to existing embolism or severe hemorrhage within 6 months prior to enrollment\n13. presence of central nervous system metastases;\n14. the presence of serum albumin ≤ 3 g\u002FdL\n15. those using strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1;\n16. women who are pregnant or breastfeeding, and patients of childbearing potential who refuse to use adequate contraception during the course of this trial (from study enrollment to the end of primary study focus or surgical treatment);\n17. who have participated in another study within 30 days prior to the administration of the first dose of study drug\n18. patients who, in the judgment of the investigator, are not suitable for participation in this study.",{"count":406,"type":22},33,[81],"For non-esophagogastric union progressive gastric cancer, the current treatment standard is D2 surgical resection combined with postoperative adjuvant chemotherapy, and for those with advanced stage (clinical stage III or above), perioperative chemotherapy mode can be chosen. For progressive esophagogastric combination cancer, neoadjuvant radiotherapy or preoperative chemotherapy can be chosen. Preoperative chemotherapy significantly improves the tumor remission rate and R0 resection rate with good safety. Irinotecan has been widely used in clinical practice, and together with the available data from the Irinotecan Liposome (II) clinical study demonstrated good safety and clinical efficacy, bringing hope for prolonging progression-free survival and overall survival for several tumor patients. In order to further explore the safety and efficacy of the neoadjuvant therapeutic application of irinotecan liposome (II) in patients with gastric cancer, the present study was conducted to provide data to guide future clinical practice.",[410],"Gastric Cancer","2025-07-30",{"date":413,"type":38},"2025-07-31",{"date":415,"type":22},"2025-08-15",{"date":396,"type":22},{"name":43,"class":44},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":45},"100594229","phase-2-neoadjuvant-radiochemotherapy-combined-with-cadonilizumab-for-local-advanced-esophageal-squamous-cell-cancer-100594229","NCT07016724","Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer","Inclusion Criteria:\n\n* diagnosed with esophageal squamous cell cancer;\n* staged with cT1N+M0\u002FcT2-3N0-3M0;\n* experienced no cancer-related treatment;\n* ECOG 0-1;\n* Expected survival more than 6 months;\n* aimed at neoadjuvant therapy for surger;\n* have adquate organ function.\n\nExclusion Criteria:\n\n* diagnosed with other types of cancer during last five years;\n* have a tendency to bleed;\n* accepted any type of cancer-related therapy.",{"count":425,"type":22},208,[81],"Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1\u002FCTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.",[337],"2025-06-08",{"date":431,"type":38},"2025-06-12",{"date":433,"type":38},"2024-08-15",{"date":435,"type":22},"2027-08-31",{"name":43,"class":44},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":45},"100587607","prognostic-value-of-neurometabolic-networks-in-crc-pvnm-crc-100587607","NCT06930586","Prognostic Value of Neurometabolic Networks in CRC (PVNM-CRC)","An Observational Study on the Prognostic Value of Neurometabolic Networks in Colorectal Cancer","PVNM-CRC","Male\u002FFemale subjects with rectal cancer of at least 18 years of age will be enrolled in this trial.",{"count":446,"type":22},213,"Colorectal cancer (CRC), with annually increasing incidence and mortality worldwide, has become the second leading cause of cancer-related death. The development of CRC often follows the canonical normal-adenoma-carcinoma (N-A-C) sequence driven by progressive accumulation of molecular genetic events, highlighting the importance of early detection and removal of precancerous lesions. However, some patients who have had adenomas removed still have a high risk of developing new adenomas or CRC, especially for those with chronic or systemic disease, indicating that a compositive regulatory network is involved in the tumorigenesis of CRC. Additionally, despite advances in therapeutic strategies having improved the prognosis of CRC patients, tumor metastasis continues to be the predominant cause of mortality. These suggest the need to transcend limitations focusing solely on intertumoral microenvironment or single-timepoint event but adopt a more systemic perspective to elucidate the mechanisms underlying the whole sequence of CRC development and progression.\n\nThe gastrointestinal (GI) tract comprises a complex ecosystem with extensive interactions between normal or neoplastic epithelial cells with immune, neuronal, and other cell types, as well as microorganisms and metabolites within the gut lumen. Specifically, the intricate relationship between the GI tract and the central nervous system (CNS), collectively known as the brain-gut axis, plays a pivotal role in the pathogenesis of gastrointestinal disorders and neoplasm. For instance, chronic stress increased the risk of colon cancer via activating the COX-2\u002FPEG2 system and promoted tumor cell dissemination by remodeling lymph vasculature. The bidirectional communications of the brain-gut axis are generally found to be mediated by neurotransmitters, inflammatory cytokines, metabolites, or gut microbiota. Nonetheless, the spotlight has shone primarily on the brain-gut crosstalk mechanisms in experimental cellular or animal models, with less attention paid to the structural and functional alterations on the brain networks at the patient level.\n\nThe evolution of functional neuroimaging modalities and neuroscience technologies has enabled accurate delineation of CNS activities. Specifically, nuclear medicine imaging technology using 2-18F fluoro-2-deoxy-D-glucose (18F-FDG) to adopt whole-body imaging information, is the optimal in vivo method for the investigation of regional human brain metabolism and associations with systemic disorders. We have previously identified the neuronal metabolic-ventricular dyssynchronization axis which might related to major arrhythmic events using myocardial perfusion imaging and the brain 18F-FDG positron emission tomography (PET). Given the potential dual interactions of the brain-gut axis, identification of specific brain regions associated with CRC development and progression might lead to a better understanding of the disease's neurobiological underpinnings and inform the development of targeted therapeutic strategies.\n\nHence, this study was structured to elucidate the role of neuro-metabolism and its potential mediator in regulating CRC tumorigenesis and metastasis. By delving into the neurometabolic-gut axis in CRC, the resulting mechanistic insights might be leveraged to identify diagnostic and prognostic biomarkers and to develop novel therapeutic interventions for CRC patients.",[449,450],"Cancer","Brain Injury",{"date":452,"type":38},"2025-04-30",{"date":454,"type":38},"2024-03-01",{"date":368,"type":22},{"name":43,"class":44},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":148,"sex":291,"minAge":465,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":4},"100589155","nr-vs-vitamin-e-in-enhancing-fertility-100589155","NCT06950736","NR vs. Vitamin E in Enhancing Fertility","Nicotinamide Riboside vs. Vitamin E for Enhancing Fertility in Advanced Maternal Age: A Randomized Parallel Trial","NRVEERSAAM","Inclusion Criteria:\n\n1. Infertile women aged between 35 and 42 years;\n2. 0.1 ng\u002FmL \\\u003C= AMH \\\u003C= 1.1 ng\u002Fml;\n3. Pregnancy aids who plan to perform in vitro fertilization and embryo transfer (antagonist program);\n4. Bilateral ovaries are present;\n5. Patients who voluntarily signed the informed consent and agreed to be followed up according to the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Adenomyosis and uterine fibroids compression of uterine uterine line;\n2. Untreated bilateral hydrosalpinx;\n3. Uncured endometrial disease;\n4. Any pregnancy occurred within 3 months before screening;\n5. Patients with clinically significant abnormal cervical examination results within 3 months before screening;\n6. Use of fertility regulators (such as clomiphene citrate, GnRH, metformin or oral contraceptives) within 1 month before randomization;\n7. Use hormone drugs within 1 month before randomization;\n8. Patients with acute infection of urinary and reproductive system;\n9. Patients with major systemic diseases, endocrine or metabolic abnormalities that are not suitable to participate in this study, as judged by the investigator;\n10. According to the judgment of the investigator, the presence of uterus (such as submucosal uterine fibroids, intermural uterine fibroids larger than 3 cm or smaller than 3 cm but affecting uterine cavity morphology, untreated endometrial polyps, uterine adhesions, uterine malformations, and ASRM stage Ⅲ-Ⅳ endometriosis). Patients with clinically significant ovarian (e.g., polycystic ovaries, ovarian cysts \\> 4 cm, inability to retrieve eggs from both or one ovary) or adnexa (e.g., hydrosalpinx) abnormalities;\n11. Patients with unexplained abnormal uterine bleeding;\n12. Patients with a history of ovarian, breast, uterus, hypothalamus, pituitary and other malignant tumors;\n13. Receive donor egg or embryo preimplantation genetic screening\u002Fembryo preimplantation genetic diagnosis (PGS\u002FPGD);\n14. Known past or current thromboembolic disease;\n15. Have a known serious mental illness or fail to understand the purpose and methods of the clinical trial, or fail to comply with the study procedures;\n16. Patients with contraindications or allergic history to the use of GnRH-a, r-hFSH, hCGα, progesterone;\n17. Those who are addicted to alcohol, tobacco, drugs or drug abuse;\n18. Being exposed to teratogenic amounts of radiation, poisons and drugs and in the action period;\n19. Patients with liver function injury, that is, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were 2.5 times higher than the upper limit of normal values;\n20. Persons who are HIV or syphilis positive;\n21. Those with positive serum pregnancy tests;\n22. Other reasons why the researcher considers it inappropriate to participate in the study. Suffers from a disease that is not suitable for the present assisted reproductive technology or for the present pregnancy;\n23. Participants who had participated in other clinical trials within 3 months prior to screening.","35 Years","42 Years",{"count":333,"type":22},[153],"This randomized controlled trial enrolled women of advanced maternal age (≥35 years) undergoing ART, who were allocated to an intervention group (oral nicotinamide riboside, NR) or a control group (oral vitamin E, VitE) for a 2-month pre-ART intervention. The study systematically evaluated NR's regulatory effects on ovarian function and ART outcomes by measuring NAD+ levels in ovarian granulosa cells (GCs) and peripheral blood mononuclear cells (PBMCs), anti-Müllerian hormone (AMH) concentrations.",[471],"Infertility Female","2025-04-27",{"date":452,"type":38},{"date":475,"type":22},"2025-05-05",{"date":477,"type":22},"2027-12-01",{"name":43,"class":44},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":45},"100587606","phase-4-a-study-of-ak112-a-pd-1-vegf-bispecific-antibody-for-resectable-hepatocellular-carcinoma-with-high-recurrence-risk-100587606","NCT06930573","A Study of AK112, a PD-1\u002F VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk","A Single-Arm, Multicenter, Exploratory Clinical Study on the Efficacy and Safety of AK112 in Perioperative Treatment of Resectable Hepatocellular Carcinoma With High Recurrence Risk","Inclusion Criteria:\n\n1\\. Signed written informed consent before any trial-related procedures. 2. Male or female aged between 18 and 75 years. 3. ECOG PS score 0-1. 4. Histologically\u002Fcytologically confirmed hepatocellular carcinoma (HCC) or meets clinical diagnosis criteria (per 2022 Chinese Primary Liver Cancer Diagnosis and Treatment Guidelines).\n\n5\\. No preoperative HCC treatment (including chemotherapy, targeted therapy, immunotherapy, cell therapy, local radiotherapy, ablation, or intervention). No lymph node invasion\u002Fdistant metastasis on preoperative imaging, and deemed suitable for radical surgery by the investigator.\n\n6\\. At least one postoperative high-risk factor for HCC recurrence:\n\n1. Single lesion more than 5 cm in longest diameter.\n2. Microvascular or macrovascular invasion.\n3. More than 3 tumor nodules.\n4. Edmondson grade at least II on tumor pathology.\n5. AFP more than 400 μg\u002FL in CNLC Ib-IIa patients.\n6. Tumor adjacent to blood vessels in CNLC Ib-IIa patients.\n7. Incomplete tumor capsule in CNLC Ib-IIa patients. 7. Child-Pugh score A or B7. 8. Expected survival more than 3 months. 9. At least one measurable lesion per RECIST 1.1. 10. Total T3 or free T3 and free T4 within normal range (thyroid replacement therapy allowed). Asymptomatic subjects with abnormal T3, free T3, or free T4 are eligible.\n\n   11\\. Adequate organ and bone marrow function, with laboratory values meeting the following criteria within 7 days before randomization (no blood products, growth factors, albumin, or corrective treatments within 14 days before obtaining these results):\n   1. Hematology: ANC at least 1.5×10⁹\u002FL; PLT at least 75×10⁹\u002FL; HGB at least 9.0 g\u002FdL.\n   2. Liver function: TBIL at most 3×ULN; ALT, AST, ALP at most 5×ULN; serum albumin at least 28 g\u002FL.\n   3. Renal function: Serum creatinine at most 1.5×ULN or CCr at least 50 mL\u002Fmin (Cockcroft-Gault formula); urine protein less than 2+ on urinalysis. For subjects with baseline urine protein at least 2+, 24-hour urine protein less than 1 g.\n   4. Coagulation: INR and APTT at most 1.5×ULN. 12. For female subjects of childbearing potential, a negative urine or serum pregnancy test within 3 days before the first study drug administration (Cycle 1, Day 1). If urine test is inconclusive, a blood pregnancy test is required. Postmenopausal females (for at least 1 year), surgically sterilized, or hysterectomized are not of childbearing potential.\n\n   13\\. All subjects with pregnancy risk must use effective contraception throughout treatment until 120 days after the last study drug dose (or 180 days after last chemotherapy dose).\n\n   Exclusion Criteria:\n   1. Past histological\u002Fcytological diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, etc.\n   2. Other malignancies within 5 years before enrollment, except those locally treated HCC. Exceptions include basal\u002Fsquamous cell skin cancer, superficial bladder cancer, cervical\u002F breast carcinoma in situ.\n   3. History of hepatic encephalopathy or liver transplantation.\n   4. Cancer thrombus in portal vein branches, superior mesenteric vein, or inferior vena cava.\n   5. Active hepatitis B\u002FC infection, with HBV DNA more than 2000 IU\u002Fml or 10⁴ copies\u002Fml; HCV RNA more than 10³ copies\u002Fml; co-positive HBsAg and anti-HCV. Those on antiviral therapy meeting the above criteria and willing to continue during the study are eligible.\n   6. Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.\n   7. Esophagogastric variceal bleeding due to portal hypertension within 6 months before first dose; current imaging shows significant esophagogastric varices.\n   8. History of significant bleeding tendency\u002Fcoagulopathy; clinically significant bleeding within 1 month before first dose (e.g., GI bleeding, hemoptysis, epistaxis); continuous antiplatelet\u002Fanticoagulant therapy within 10 days before first dose.\n   9. Arterial\u002Fvenous thromboembolism within past 6 months, including myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis. Exceptions: stable thrombosis after routine anticoagulation for implanted venous ports\u002F catheters or superficial vein thrombosis; low-dose LMWH (e.g., enoxaparin 40 mg\u002Fday) allowed.\n   10. History of myocarditis, cardiomyopathy, malignant arrhythmias. Unstable angina, MI, CHF (NYHA ≥Class 2), or vascular disease requiring hospitalization within 12 months before first dose; other cardiac impairments affecting drug safety assessment. Severe ulcers, unhealed wounds, GI perforation, fistula, obstruction, abscess, or acute GI bleeding within 6 months before first dose; thromboembolic events, TIA, stroke within 6 months before first dose; COPD exacerbation, hypertensive crisis\u002Fencephalopathy within 1 month before first dose; current hypertension uncontrolled by oral medication (systolic BP more than 150 mmHg or diastolic BP more than 90 mmHg).\n   11. History or current non-infectious pneumonia\u002Finterstitial lung disease requiring systemic corticosteroids; active or past definite inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea); active autoimmune disease requiring systemic treatment within past 2 years (e.g., DMARDs, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroid hormones, insulin, physiological corticosteroids for adrenal\u002Fpituitary insufficiency) is not considered systemic treatment.\n   12. History of immunodeficiency; positive HIV antibody test; current long-term use of systemic corticosteroids or other immunosuppressants (except short-term corticosteroids for COPD-related dyspnea or temporary allergy prevention).\n   13. Known active tuberculosis (TB); suspected active TB requires clinical exclusion; known active syphilis infection.\n   14. Severe infection within 4 weeks before first dose (e.g., requiring hospitalization, sepsis, severe pneumonia); active infection treated with systemic anti-infectives within 2 weeks before first dose (excluding antiviral therapy for hepatitis B\u002FC).\n   15. Past systemic chemotherapy or bevacizumab\u002Fbiosimilar treatment.\n   16. Past immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1, CTLA-4, CD47, SIRPα, LAG-3 antibodies), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies), or any immunotherapy targeting tumor immune mechanisms.\n   17. Past local therapy for liver lesions, including TACE, TARE, HAIC, or radiotherapy.\n   18. Systemic anti-tumor traditional Chinese medicine or immunomodulatory drugs (e.g., thymosin, interferon, interleukin) within 2 weeks before first dose (except those locally used to control pleural\u002Fascitic fluid).\n   19. Live\u002Fattenuated vaccine administration within 30 days before first dose or planned during study; inactivated vaccines are allowed.\n   20. Known allergy to any study drug component; history of severe hypersensitivity to other monoclonal antibodies.\n   21. Known psychiatric disease, drug abuse, alcoholism, or substance addiction.\n   22. Pregnant or breastfeeding women.\n   23. Any condition, disease, or abnormality that may interfere with study results, hinder study participation, or pose additional risk, as determined by the investigator.",{"count":293,"type":22},[488],"PHASE4","This study is a single-arm, open-label study. To assess the efficacy and safety of AK112 therapy in patients with resectable hepatocellular carcinoma at high risk of recurrence. The primary endpoint is the 12-month RFS rate of resectable hepatocellular carcinoma.",[491],"HCC","2025-04-09",{"date":494,"type":38},"2025-04-16",{"date":496,"type":38},"2024-12-04",{"date":498,"type":22},"2027-12-24",{"name":43,"class":44},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":515,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":523,"locationsCount":45},"100448091","comparison-of-the-efficacy-and-safety-of-immunoadsorption-and-intravenous-immunoglobulin-for-guillain-barre-syndrome-100448091","NCT05114941","Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome","A Prospective, Multi-center, Randomized Parallel Controlled Clinical Study on the Efficacy and Safety of Protein A Immunoadsorption and Intravenous Immunoglobulin in the Treatment of Guillain-Barre Syndrome","GBS-PRAISING","Inclusion Criteria:\n\n1. Meet the diagnostic criteria of Guillain - Barre syndrome;\n2. The onset is within 2 weeks;\n3. Age is greater than or equal to 18 years old and less than or equal to 60 years old;\n4. Hughes function classification is greater than or equal to 3;\n5. The subject or his legal representative can understand the purpose of the research, show sufficient compliance with the research protocol, and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Those who are pregnant;\n2. Three months before the screening period, receive immunoadsorption therapy or intravenous immunoglobulin therapy;\n3. Those who have a history of allergies in the membrane of the plasma separator;\n4. Those who must use angiotensin-converting enzyme inhibitor drugs within 1 week before being included in the trial and during treatment and cannot be stopped;\n5. Severe active bleeding or diffuse intravascular coagulation, patients with systemic circulatory failure that are difficult to correct with drugs;\n6. Severe cardiac insufficiency, that is, those who have reached NYHA IV according to the heart failure classification standards of the New York Heart Association (NYHA);\n7. There are contraindications to intravenous immunoglobulin;\n8. Those with other system autoimmune diseases;\n9. Diagnosis of variant GBS: such as Miller-Fisher syndrome, GBS with cranial nerve damage, sensory GBS, pan-autonomous GBS. Patients with chronic inflammatory demyelinating polyperipheral neuropathy whose condition has been significantly alleviated when visiting a doctor;\n10. Subjects who have participated in any other drug or medical device clinical trials within 1 month before entering the screening period; Note: Subjects who participated in observational studies (that is, the study does not require changes or other interventions) will not be excluded;\n11. Patients who cannot obtain informed consent;\n12. Those who cannot receive active and comprehensive treatment.","60 Years",{"count":510,"type":22},204,[153],"Guillain-Barre syndrome is an immune-mediated acute inflammatory peripheral neuropathy. The currently effective treatment methods include intravenous immunoglobulin and plasma exchange. Immunoadsorption has been widely used to treat immune-related diseases. There are currently no prospective large-sample clinical trials of immunoadsorption therapy for Guillain-Barre syndrome. The neuro-intensive care unit of the First Affiliated Hospital of Zhengzhou University is preparing to carry out a prospective, multi-center, randomized parallel controlled clinical study on the efficacy and safety of protein A immunoadsorption and intravenous immunoglobulin (IVIG) in the treatment of Guillain-Barre syndrome. It is estimated that 204 patients with Guillain-Barre syndrome will be included. The patients will be randomly assigned to the immunoadsorption group and the IVIG group. The primary outcome measure: changes in Hughes scores (4 weeks after starting treatment vs. baseline (before starting treatment) ). This study aims to explore the efficacy and safety of protein A immunoadsorption and intravenous immunoglobulin in the treatment of Guillain-Barre syndrome.",[514],"Guillain-Barre Syndrome",[516,517],"immunoadsorption","intravenous immunoglobulin",{"date":519,"type":38},"2025-03-12",{"date":521,"type":22},"2026-01-01",{"date":163,"type":22},{"name":43,"class":44},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":45},"100582928","energy-ct-in-imaging-and-diagnosis-of-gastric-cancer-100582928","NCT06869694","Energy CT in Imaging and Diagnosis of Gastric Cancer","Diagnostic and Predictive Performance of Dual-\u002F Muti- Energy CT and MRI in the Treatment Response and Survival Prognosis of Gastric Cancer","CTIDGC","Inclusion Criteria:\n\n1. Pathological biopsy confirmed gastric cancer;\n2. Surgery: patients undergoing radical gastrectomy. Patients undergoing exploratory abdominal surgery or palliative tumor resection were still included in the study when peritoneal metastasis or adjacent organ invasion was identified intraoperatively and radical surgical resection was not possible.\n\nExclusion Criteria:\n\n1. Refusal or inability to sign informed consent;\n2. CT or MRI images are poor or the focus is small and CT images are not clear;\n3. Patients with other tumors complicated with patients with important organ dysfunction.",{"count":533,"type":22},300,"Accurate preoperative prediction of risk stratification, treatment response, and survival prognosis in gastric cancer is important for improving clinical treatment decisions, prolonging patient survival, and improving patient quality of life. The purpose of this study is to investigate the performance of the multi-parametric magnetic resonance imaging (mpMRI) and Dual-\u002FMuti-energy CT and photon-counting Detector CT(PCD-CT) in the diagnosis and management of gastric cancer.",[410,536],"CT",[536,538],"Gastric cancer","2025-03-06",{"date":541,"type":38},"2025-03-11",{"date":543,"type":38},"2024-09-01",{"date":545,"type":22},"2028-09-01",{"name":43,"class":44},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":554,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":45},"100559466","phase-2-a-prospective-open-label-randomized-controlled-multicenter-clinical-study-of-msd-hsct-using-a-tbi-or-tmli-conditioning-regimen-for-pediatric-all-100559466","NCT06564493","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Matched Sibling Donor Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.\n2. Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.\n3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years.\n4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.\n5. Donor Availability: There must be a suitable matched sibling donoravailable, and the participant must consent to undergo MSD hematopoietic stem cell transplantation (MSD-HSCT).\n6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:\n\n   * Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.\n   * Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.\n   * Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml\u002Fmin. o Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.\n\nExclusion Criteria: To be eligible for inclusion in the study, participants must not meet any of the following criteria:\n\n1\\. The patient has not achieved hematologic remission before transplantation. 2. The patient has chosen a non-MSD donor.\n\n3\\. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.\n\n4\\. The patient has an active or refractory infection, or other life-threatening complications.\n\n5\\. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.\n\n6\\. The patients or guardians refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.\n\n7\\. The investigator deems the patient unsuitable for participation in the study for any other reason.","1 Year","17 Years",{"count":557,"type":22},170,[81],"This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.",[561],"Acute Lymphoblastic Leukemia, Pediatric","2025-02-16",{"date":564,"type":38},"2025-02-18",{"date":566,"type":22},"2025-03-01",{"date":568,"type":22},"2029-12-31",{"name":43,"class":44},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":577,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":585,"leadSponsor":586,"locationsCount":45},"100558902","phase-2-a-prospective-open-label-randomized-controlled-multicenter-clinical-study-of-msd-hsct-using-a-tbi-or-tmli-conditioning-regimen-for-adult-all-100558902","NCT06557161","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Matched Sibling Donor Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Adult Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed Consent: Participants must voluntarily sign a written informed consent form.\n2. Age and Gender: Participants should be male or female, aged 18-65 years, inclusive.\n3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to adults aged 18-65 years.\n4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.\n5. Donor Availability: There must be a suitable mathced sibling donor available, and the participant must consent to undergo MSD hematopoietic stem cell transplantation (MSD-HSCT).\n6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:\n\n   * Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.\n   * Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.\n   * Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml\u002Fmin.\n   * Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.\n7. Reproductive Health:\n\n   * Women of childbearing potential must test negative for pregnancy with a Human Chorionic Gonadotropin (HCG) test, confirmed by immunofluorescence during both screening and baseline periods. They must also agree to use effective contraception for at least one year following the transplantation.\n   * Male participants with female partners of childbearing potential must agree to use effective barrier contraception and refrain from sperm donation for at least one year following the transplantation.\n\nExclusion Criteria: To be eligible for inclusion in the study, participants must not meet any of the following criteria:\n\n1. The patient has not achieved hematologic remission before transplantation.\n2. The patient has chosen a non-MSD donor.\n3. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.\n4. The patient has an active or refractory infection, or other life-threatening complications.\n5. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.\n6. The patient refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.\n7. The investigator deems the patient unsuitable for participation in the study for any other reason.","65 Years",{"count":557,"type":22},[81],"This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.",[582],"Acute Lymphoblastic Leukemia, Adult",{"date":564,"type":38},{"date":566,"type":22},{"date":568,"type":22},{"name":43,"class":44},""]