[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tongji Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,154,0,25,[9,42,62,84,108,140,164,184,214,241,275,300,324,349,380,400,427,445,466,495,522,545,571,594,618],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054079","phase-2-neoadjuvant-cardonilizumab-combined-with-neoadjuvant-chemoradiotherapy-can-resect-locally-advanced-esophageal-squamous-cell-carcinoma-100054079",false,"NCT07699185","Neoadjuvant Cardonilizumab Combined With Neoadjuvant Chemoradiotherapy Can Resect Locally Advanced Esophageal Squamous Cell Carcinoma","Neoadjuvant Cardonilizumab Combined With Chemotherapy Versus Neoadjuvant Concurrent Chemoradiotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Multicenter, Open-label, Randomized, Controlled Study","Inclusion Criteria:\n\n* Sign a written informed consent before implementing any procedures related to the trial;\n* Male or female, 18 years old ≤75 years old;\n* Patients with histologically proven ESCC with a pathological stage of cT1N2M0 or cT2-3N0-2M0 according to AJCC Version 8 TNM stage and eligible for R0 surgical resection prior to treatment;\n* Have not received systematic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy\u002Fimmunotherapy, etc.;\n* Patients who agree to radical surgical treatment and are judged by the surgeon to have no surgical contraindications;\n* ECOG score 0-1;\n* Expected survival time \\>6 months;\n* For adequate organ function, subjects must meet the following laboratory criteria:\n* For adequate organ function, subjects must meet the following laboratory criteria:\n\n  1. The absolute value of neutrophil (ANC) ≥1.5x109\u002FL in the past 14 days without the use of granulocyte colony-stimulating factor;\n  2. Platelets ≥100×109\u002FL without blood transfusion in the past 14 days;\n  3. Hemoglobin \\>9g\u002FdL in the last 14 days without blood transfusion or use of erythropoietin;\n  4. Total bilirubin ≤1.5× upper limit of normal (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN\n  6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n  7. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times 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 with total T3 (or FT3) and FT4 within the normal range can also be enrolled;\n  9. The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included);\n* For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1) and the results are negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;\n* If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).\n\nExclusion Criteria:\n\n* Diagnosis of other malignant diseases (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and\u002For carcinoma in situ after radical resection) within 1.5 years;\n* Known endoscopic signs of active bleeding;\n* Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;\n* Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.);\n* Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;\n* An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;\n* Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (≤10 mg\u002F day of prednisone or equivalent) is permitted;\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Known allergy to the drugs used in this study;\n* Has not fully recovered from toxicity and\u002For complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);\n* Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled:\n\n  1. HBV viral load \\\u003C2500 copies \u002Fml (500 IU\u002Fml) prior to initial dosing, subjects should receive anti-HBV therapy throughout study chemotherapy therapy to avoid viral reactivation\n  2. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required\n* Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n* Received live vaccine within 30 days prior to the first dose (cycle 1, day 1);\n* Note: It is permissible to receive injectable inactivated virus vaccine against seasonal influenza within 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted\n* Pregnant or lactating women;\n* The presence of any serious or uncontrolled systemic disease, such as:\n\n  1. The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;\n  2. Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;\n  3. Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;\n  4. Poor blood pressure control (systolic \\> 140 mmHg, diastolic \\> 90 mmHg);\n  5. There is a history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first administration, or there is currently clinically active interstitial lung disease;\n  6. Active pulmonary tuberculosis;\n  7. There is an active or uncontrolled infection that requires systemic treatment;\n  8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n  11. Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity \\> 1.0 g;\n  12. Patients with mental disorders who cannot cooperate with treatment; Evidence of medical history or disease that might interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":21,"type":22},336,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications",[28],"Esophageal Squamous Cell Carcinoma","RECRUITING","2026-07-07",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2024-01-29",{"date":37,"type":22},"2026-07-01",{"name":39,"class":40},"Tongji Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100054103","tdln-guided-lymphadenectomy-after-neoadjuvant-immunochemotherapy-for-escc-100054103","NCT07697898","TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC","Tumor-Draining Lymph Node Preservation-Guided Intraoperative Lymphadenectomy After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Observational Cohort Study","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of sex.\n* Eastern Cooperative Oncology Group performance status of 0 to 1.\n* Histologically confirmed thoracic esophageal squamous cell carcinoma.\n* Received neoadjuvant immunochemotherapy and considered suitable for curative surgery after multidisciplinary team evaluation.\n* Clinically resectable locally advanced or locally progressive disease without evidence of distant metastasis.\n* Completed preoperative contrast-enhanced computed tomography of the neck, chest, and abdomen. Positron emission tomography-computed tomography and\u002For endoscopic ultrasound may be performed if clinically available.\n* Considered by the investigator to be able to tolerate curative esophagectomy and standard systematic lymphadenectomy.\n\nExclusion Criteria:\n\n* Non-squamous cell carcinoma histology or concurrent primary malignancy requiring treatment.\n* Previous curative surgery for esophageal cancer or previous radiotherapy for the current esophageal lesion.\n* Evidence of distant metastasis, unresectable disease, or considered unsuitable for curative surgery after multidisciplinary team evaluation.\n* Severe autoimmune disease requiring long-term systemic immunosuppressive therapy.\n* Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that prevents surgery or completion of study-related assessments.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, including poor compliance, inability to complete scheduled follow-up, or inability to provide key study data.",{"count":50,"type":22},400,"24 Months","OBSERVATIONAL","This is a prospective, multicenter, observational cohort study of patients with esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy.\n\nThe study will not alter the current standard surgical approach. All patients will receive curative esophagectomy and systematic lymph node dissection according to institutional practice. Lymph nodes will be separated and recorded by anatomical station during surgery, followed by station-level pathological assessment. Imaging findings, pathological response, perioperative outcomes, recurrence patterns, disease-free survival, overall survival, and selected immune microenvironment features will be collected and analyzed.\n\nThe purpose of this study is to characterize station-level residual lymph node metastasis risk and immune activity after neoadjuvant immunochemotherapy. The findings may help identify candidate lymph node stations for future research on individualized or lymph node-preserving surgical strategies in esophageal squamous cell carcinoma.",[55],"Esophageal Squamous Cell Carcinoma (ESCC)","NOT_YET_RECRUITING",{"date":32,"type":33},{"date":37,"type":22},{"date":60,"type":22},"2031-06-30",{"name":39,"class":40},{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":83,"locationsCount":41},"100644820","neoadjuvant-pd-1-inhibitor-plus-sox-chemotherapy-with-or-without-short-course-radiotherapy-for-locally-advanced-upper-gastric-or-gej-adenocarcinoma-100644820","NCT07674342","Neoadjuvant PD-1 Inhibitor Plus SOX Chemotherapy With or Without Short-Course Radiotherapy for Locally Advanced Upper Gastric or GEJ Adenocarcinoma","A Prospective, Multicenter, Randomized Controlled Study of Neoadjuvant PD-1 Inhibitor Combined With SOX Chemotherapy With or Without Short-Course Radiotherapy (With Omission of Regional Lymph Node Irradiation) for Locally Advanced Upper Gastric or Gastroesophageal Junction Adenocarcinoma","POSIT","Inclusion Criteria:\n\n* The participant voluntarily joins this study, is able to complete the signing of the informed consent form, and demonstrates good compliance.\n* Age 18-75 years (at the time of signing the informed consent), regardless of gender.\n* Adenocarcinoma confirmed by histology and\u002For cytology, diagnosed as locally advanced according to the AJCC 8th edition criteria, with cTNM staged as cT3-4 or N+ M0 based on endoscopic ultrasound or contrast-enhanced CT\u002FMRI, and the patient agrees to receive neoadjuvant therapy; the lesion is assessed by the investigator as resectable or potentially resectable; after MDT evaluation, radical resection is planned with standard D2 lymph node dissection.\n* Primary lesion site restrictions: (1) Adenocarcinoma of the gastroesophageal junction: Siewert type II-III; (2) Upper stomach cancer: the lower edge of the tumor is located within the upper third of the stomach, mainly involving the cardia, fundus, or upper part of the stomach body.\n* Has not previously received systemic treatment for the current disease, including anti-tumor radiotherapy\u002Fchemotherapy or immunotherapy.\n* ECOG score 0-1.\n* Estimated survival period \\>= 6 months.\n* Preoperative chest, abdominal, and pelvic CT, as well as FAPI PET or PET-CT, to rule out distant metastasis.\n* Major organ function is satisfactory and meets the following criteria: (1) Complete blood count (without blood transfusion or use of hematopoietic growth factors within 14 days to correct status): hemoglobin (Hb) \\>=90 g\u002FL; absolute neutrophil count (ANC) \\>=1.5 × 10\\^9\u002FL; platelets (PLT) \\>=80 × 10\\^9\u002FL; (2) Biochemical tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C=2.5 × ULN; total bilirubin (TBIL) \\\u003C=1.5 × ULN; serum creatinine (Cr) \\\u003C=1.5 × ULN, or creatinine clearance \\>=60 mL\u002Fmin; (3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) \\\u003C=1.5 × ULN; (4) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \\>=50%.\n* The doctor clinically determines that there is sufficient organ function.\n* Subjects of reproductive potential must use appropriate contraception during the study and for 120 days after the study ends, have a negative serum pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding.\n\nExclusion Criteria:\n\n* Undergo radiotherapy within 4 weeks before enrollment, or radionuclide therapy within 8 weeks.\n* Within 6 months before enrollment: esophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, fistulas, intestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding.\n* Diagnosis of malignancies other than gastric cancer within 5 years prior to first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For completely resected carcinoma in situ).\n* Presence of distant metastasis (M1), including but not limited to: peritoneal metastasis (confirmed by imaging or laparoscopy), ascites or positive peritoneal lavage cytology, metastasis to organs such as liver, lung, or bone; cases where imaging suggests metastasis to para-aortic lymph nodes (No.16).\n* Imaging suggests excessive regional lymph node burden: suspicious\u002Fpositive lymph node involvement in \\>=3 anatomical stations; or multiple lymph nodes are fused\u002Fform a cluster (matted nodes); or any lymph node has a short axis \\>=15 mm.\n* The tumor lesion has a serious tendency to bleed (such as the presence of an active deep large ulcer, a history of vomiting blood or black stools within 2 months before signing the informed consent, or a risk of major gastrointestinal bleeding as determined by the investigator), or has received blood transfusion treatment within 4 weeks prior to the study medication.\n* Inability to swallow oral medications, malabsorption syndrome, or other conditions affecting gastrointestinal absorption.\n* Currently participating in interventional clinical research treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration.\n* Previously received systemic or local anti-tumor treatment for gastric cancer, including curative surgery, chemotherapy, radiotherapy, immunotherapy (such as immune checkpoint inhibitors, agonists, or cell therapy), biological agents, or small molecule targeted drugs.\n* Systemic therapy with traditional Chinese medicine having anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, except for local use to control pleural effusion) within 2 weeks prior to the first dose.\n* Active autoimmune disease that required systemic treatment (such as disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first administration. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatment.\n* The participant is receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other forms of topical corticosteroids) or any other form of immunosuppressive therapy within the 7 days prior to the first study drug administration; Note: The use of physiological doses of corticosteroids (\\\u003C=10 mg\u002Fday of prednisone or equivalent) is allowed; short courses of corticosteroids are allowed for medically necessary reasons such as chemotherapy-induced nausea, premedication for contrast agent allergy, or other short-term medical needs.\n* Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n* Known allergies to medications used in this study.\n* Peripheral neuropathy \\>= grade 2.\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive).\n* Subjects with active hepatitis B or hepatitis C (HBsAg positive with HBV DNA levels above the upper limit of normal; HCVAb positive with HCV RNA levels above the upper limit of normal (Note: Subjects who are HBV DNA positive may be enrolled if they are willing to undergo full antiviral treatment throughout the study and have already started treatment before enrollment, subject to consultation with an infectious disease specialist).\n* Within 30 days before the first dose (Cycle 1, Day 1), live vaccines were administered; inactivated influenza vaccines for injection against seasonal flu are allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccines are not allowed.\n* Pregnant or breastfeeding women.\n* Presence of any severe or uncontrollable systemic disease, such as: (1) Significant and symptomatic abnormalities on resting electrocardiogram in rhythm, conduction, or morphology that are difficult to control, such as complete left bundle branch block, second-degree or higher heart conduction block, ventricular arrhythmias, or atrial fibrillation; (2) Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class \\>= 2; (3) Any arterial thrombosis, embolism, or ischemia within 6 months prior to treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; (4) Long-term poorly controlled hypertension (systolic blood pressure \\>160 mmHg, diastolic blood pressure \\>100 mmHg); (5) History of non-infectious pneumonia requiring corticosteroid therapy within 1 year before initial dosing, or currently active interstitial lung disease; (6) Significant bleeding disorders or a history of coagulopathy; current or past long-term anticoagulant therapy (e.g., atrial fibrillation with CHADS2 score \\>=2); (7) Active pulmonary tuberculosis; (8) History of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or chronic diarrhea; (9) Major surgery or major trauma within 30 days prior to treatment; minor local surgery within 3 days prior to treatment (excluding central venous catheter placement via peripheral vein); (10) Presence of active or uncontrolled infection requiring systemic therapy; (11) Presence of clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction; (12) Uncontrolled comorbidities including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer or gastritis, or mental\u002Fsocial conditions that interfere with protocol compliance or informed consent; (13) Poorly controlled diabetes (fasting blood glucose (FBG) \\>10 mmol\u002FL); (14) Urinalysis indicating proteinuria \\>=++, confirmed by 24-hour urine protein quantification \\>1.0 g.\n* Known history of mental illness, substance abuse, alcoholism, or drug addiction.\n* Any history or evidence of disease that may interfere with the trial results, hinder the subject's full participation in the study, abnormal treatment or laboratory test results, or any other condition that the investigator considers unsuitable for enrollment. The investigator believes that there are other potential risks making the subject unsuitable to participate in this study.\n* Local or systemic diseases caused by tumors, or tumor-related complications with high medical risk or uncertain prognosis (for example, leukocyte response resulting in leukocytes \\>20 × 10\\^9\u002FL, cachexia, weight loss \\>10% in the three months before screening), or BMI \\\u003C=18).",{"count":71,"type":22},146,[73],"NA","This study is a prospective, open-label, multicenter, randomized controlled clinical trial designed to enroll patients with previously untreated, resectable locally advanced adenocarcinoma of the upper stomach or gastroesophageal junction. After providing informed consent and meeting the eligibility criteria, enrolled patients will be randomized into two cohorts: Cohort 1 (experimental group) will receive sequential short-course radiotherapy (SCRT) followed by four cycles of SOX plus serplulimab as neoadjuvant therapy prior to surgery; Cohort 2 (control group) will receive four cycles of SOX plus serplulimab as neoadjuvant therapy before surgery. Postoperatively, all patients will continue with four cycles of SOX plus serplulimab as adjuvant therapy, with serplulimab maintained for one year. If patients do not meet the criteria for radical gastrectomy, alternative conservative treatments or surgical approaches will be considered following multidisciplinary team (MDT) discussion. The study aims to evaluate the efficacy and safety of SOX combined with serplulimab, and sequential SCRT followed by SOX plus serplulimab as neoadjuvant therapy leading to radical resection of gastric cancer. All enrolled patients will undergo PD-L1 expression analysis (CPS and TPS scores) and microsatellite instability status (MSI-H population). Where tissue availability and research center conditions permit, exploratory assessments will include minimal residual disease (MRD) measured at baseline, after neoadjuvant therapy, post-surgery, and after adjuvant therapy, tumor mutational burden (TMB), and whole-exome sequencing of tumor tissue. Radiological evaluations will be conducted every 3 months ± 1 week for the first 2 years post-surgery, then every 6 months ± 2 weeks up to 5 years, and annually thereafter until disease recurrence. Survival follow-up will occur every three months after recurrence. Safety visits will span from the first dose to 30 days after the last dose or initiation of new antitumor therapy.",[76],"Locally Advanced Proximal Gastric or Gastroesophageal Junction Adenocarcinoma","2026-06-23",{"date":79,"type":33},"2026-06-29",{"date":81,"type":22},"2026-06-30",{"date":60,"type":22},{"name":39,"class":40},{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"100628592","mindfulness-intervention-on-minimally-invasive-vascular-surgery-100628592","NCT07463638","Mindfulness Intervention on Minimally Invasive Vascular Surgery","Effect of Mindfulness Intervention Based on Virtual Reality Technology on Anxiety and Pain in Minimally Invasive Vascular Surgery Under Local Anesthesia: a Single-center, Prospective, Randomized Controlled Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years old.\n2. ASA physical status classification I-III.\n3. Diagnosis of superficial varicose veins confirmed by clinical examination and imaging studies (e.g., Doppler ultrasound, digital subtraction angiography), with documented venous insufficiency and great saphenous vein varicosity; CEAP classification grade 3-5.\n4. Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia.\n5. Voluntary participation in this study with signed informed consent.\n6. Able to cooperate with all examinations and follow-up visits required during the study.\n7. No other severe systemic diseases or surgical contraindications (e.g., severe cardiopulmonary dysfunction, coagulation abnormalities) that may compromise surgical safety or interpretation of study results.\n\nExclusion Criteria:\n\n1. Cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score ≤26).\n2. Inability to wear VR equipment, or presence of sensory impairment (blindness or deafness).\n3. History of the same type of surgery.\n4. Presence of chronic or acute pain unrelated to peripheral vascular disease diagnosis.\n5. Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the past 30 days.\n6. Pregnancy or breastfeeding.\n7. Currently receiving or previously participated in psychological intervention.\n8. Prior mindfulness experience, documented history of psychiatric illness in medical records, or consultation with a trauma psychologist during the current hospitalization.",true,"80 Years",{"count":94,"type":22},160,[73],"Background: Patients undergoing minimally invasive vascular surgery under local anesthesia often experience significant anxiety and pain, which may compromise surgical outcomes. Virtual reality (VR)-based mindfulness interventions may offer a novel approach to enhance the perioperative experience. Methods: This single-center, prospective randomized controlled trial will enroll 160 patients, randomly assigned in a 1:1 ratio to either the intervention group (VR mindfulness intervention) or the control group (standard care). Primary outcome: State trait anxiety scale (STAI-State) measures anxiety. Secondary outcomes: Numeric Rating Scale (NRS) for pain, vital signs, sleep quality, fatigue levels, satisfaction. Expected Results: VR mindfulness intervention is anticipated to significantly reduce anxiety and pain levels while improving sleep quality, fatigue levels, and patient satisfaction. Conclusion: As a safe, cost-effective, and immersive non-pharmacological intervention, VR mindfulness therapy holds promise for enhancing perioperative care quality.",[98,99],"Anxiety","Pain","2026-06-15",{"date":102,"type":33},"2026-06-17",{"date":104,"type":22},"2026-07",{"date":106,"type":22},"2027-01",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":115,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":118,"studyType":52,"phases":4,"briefSummary":119,"conditions":120,"keywords":127,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":41},"100641814","perioperative-quantitative-sensory-testing-and-incision-pain-mapping-in-thoracic-surgery-100641814","NCT07653932","Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery","Perioperative Pain Phenotyping and Incision Pain Mapping Using Quantitative Sensory Testing in Patients Undergoing Thoracoscopic or Robotic-assisted Lung Resection: A Prospective Observational Pilot Cohort Study","Inclusion Criteria:\n\n1. Male\n2. Scheduled to undergo elective thoracoscopic or robotic-assisted lung resection.\n3. American Society of Anesthesiologists physical status I to III.\n4. Able to understand and communicate adequately and to complete study questionnaires independently or with assistance from study staff.\n5. Willing to undergo QST assessment, perioperative venous blood sampling, and postoperative follow-up.\n6. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Definite chronic chest wall, shoulder, back, or upper limb pain with an average 2. Numeric Rating Scale score of 3 or higher during the preceding week.\n\n3\\. Definite painful neuropathic disease or long-term use of opioids or other analgesics for more than 2 weeks.\n\n4\\. Peripheral neuropathy, spinal cord disease, or other neurological disease that may substantially interfere with interpretation of QST results.\n\n5\\. Severe cognitive impairment, psychiatric disorder, communication disorder, or inability to complete questionnaires and QST assessments.\n\n6\\. Active infection, active autoimmune disease, or other disease condition that may substantially affect inflammatory protein measurements.\n\n7\\. Emergency surgery, conversion to open thoracotomy, extensive chest wall resection, or severe intraoperative complications.\n\n8\\. Any condition that, in the opinion of the investigator, makes the participant unsuitable for continued participation in the study.","MALE",{"count":117,"type":22},46,"3 Months","Postoperative pain remains a common and clinically important burden after thoracic surgery and may progress to chronic postsurgical pain. Conventional pain assessment mainly relies on patient-reported pain intensity and analgesic consumption, which may not fully capture peri-incisional sensory abnormalities, mechanical hyperalgesia, or central sensitization.\n\nThis prospective observational pilot cohort study aims to evaluate the feasibility and acceptability of perioperative quantitative sensory testing (QST) and incision pain mapping in adult patients undergoing elective thoracoscopic or robotic-assisted lung resection. Participants will undergo baseline assessment before surgery, serial postoperative pain assessments during the first 72 hours, QST and mechanical hyperalgesia pain mapping at 48-72 hours after surgery, and follow-up assessments at discharge, 1 month, and 3 months after surgery.\n\nThe primary feasibility outcomes include recruitment rate, QST completion rates, follow-up completion rates, QST-related discontinuation rate, study-related adverse events, and data completeness. The main clinical mechanistic outcome is the area of peri-incisional mechanical hyperalgesia at 48-72 hours after surgery. Secondary outcomes include acute postoperative pain intensity, pain burden over 72 hours, opioid consumption, quality of recovery, QST changes, pain-map characteristics, and chronic postsurgical pain at 3 months.\n\nThis study will not assign or modify therapeutic interventions. All anesthetic, surgical, and analgesic management will be determined by the routine clinical care team. The study is expected to provide feasibility data, preliminary effect estimates, and mechanistic information for future larger perioperative pain studies.",[121,122,123,124,125,126],"Postoperative Pain","Chronic Postsurgical Pain","Thoracic Surgery","Lung Resection","Mechanical Hyperalgesia","Central Sensitization",[128,129,130,131,132],"Quantitative sensory testing","QST","Incision pain mapping","Thoracoscopic surgery","Perioperative pain phenotype","2026-06-13",{"date":102,"type":33},{"date":136,"type":22},"2026-06-08",{"date":138,"type":22},"2027-02-28",{"name":39,"class":40},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":41},"100642751","wearable-device-based-early-warning-of-postoperative-complications-in-thoracic-surgery-100642751","NCT07646730","Wearable Device-Based Early Warning of Postoperative Complications in Thoracic Surgery","Development and Validation of a Wearable Device-Based Early Warning Model for Postoperative Complications in Thoracic Surgery: A Retrospective and Prospective Cohort Study","wearable","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Hospitalized in the Department of Thoracic Surgery of Tongji Hospital and scheduled to undergo thoracic surgery.\n3. Able to wear the study-designated wearable device after hospital admission and expected to continue wearing the device and\u002For uploading data within 30 days after discharge.\n\nExclusion Criteria:\n\n1. Patients or family members are unwilling to wear the wearable device or unable to meet the required wearing time.\n2. Severe or unstable psychiatric disease, such as severe depression or schizophrenia.\n3. Pregnancy or lactation.\n4. Allergy to the watch strap material or local skin conditions that prevent wearing the device.\n5. Unable to complete follow-up within 30 days after discharge.",{"count":149,"type":22},650,"After thoracic surgery, some patients may develop complications such as lung infection, abnormal heart rhythm, fluid around the lung, prolonged air leak, wound infection, emergency department visits, or hospital readmission. These problems may not be found early if monitoring is only done during routine vital sign checks or follow-up visits.\n\nThis study will evaluate whether data collected by a wearable device can help identify early warning signs of postoperative complications in patients undergoing thoracic surgery. The wearable device will collect information such as heart rate, oxygen level, skin temperature, physical activity, sleep, and wearing status.\n\nThe study includes two parts. First, the researchers will review previously collected wearable device and medical record data to develop an early warning model. Second, new patients undergoing thoracic surgery will wear the device from hospital admission until about 30 days after discharge. The model will then be tested to see how well it predicts complications that require medical intervention within 30 days after surgery.\n\nThe main goal is to evaluate how accurately the wearable device-based model can identify patients who develop postoperative complications and how early the model can provide a warning before the complication is clinically confirmed.",[152,123,153],"Postoperative Complications","Perioperative Monitoring",[155,156,152,123],"Wearable Device","Early Warning Model","2026-06-12",{"date":100,"type":33},{"date":160,"type":33},"2025-12-16",{"date":162,"type":22},"2026-12-15",{"name":39,"class":40},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":172,"studyType":52,"phases":4,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":41},"100637676","prospective-clinical-database-construction-for-liver-cancer-diagnosis-and-treatment-100637676","NCT07587216","Prospective Clinical Database Construction for Liver Cancer Diagnosis and Treatment","Inclusion Criteria:\n\n* Male or female aged ≥18 years at the time of signing the informed consent form\n* Clinically or histologically confirmed diagnosis of liver cancer\n* Recieving treatment and follow-up in Tongji Hospital\n\nExclusion Criteria:\n\n\\- Refuse participanting in this study",{"count":171,"type":22},800,"2 Years","This study is a prospective, observational, real-world cohort study. We aim to establish a prospective database in the Department of Hepatobiliary and Pancreatic Surgery, systematically collecting and integrating patients' full-course diagnostic and therapeutic information along with long-term outcomes. This will enable objective evaluation of prognosis and treatment efficacy in real-world clinical practice, while providing a data foundation and evidence support for subsequent optimization of clinical decision-makin",[175],"Liver Cancer (Primary and Metastatic)","2026-06-02",{"date":178,"type":33},"2026-06-04",{"date":180,"type":33},"2026-01-01",{"date":182,"type":22},"2029-12-31",{"name":39,"class":40},{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100619917","phase-2-a-multicenter-prospective-clinical-trial-with-a-concurrent-control-evaluating-methotrexate-combined-with-rituximabsintilimab-and-pirtobrutinib-vs-investigator-selected-standard-of-care-in-treatment-naive-pcnsl-100619917","NCT07350850","A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL","In Treatment-Naive Patients With Primary Central Nervous System Lymphoma (PCNSL): A Multicenter, Prospective, Concurrent-Control Study of Methotrexate, , Rituximab,, Sintilimab ,Pirtobrutinib Versus Investigator-Selected Standard of Care","PRIME-PCNSL","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Voluntarily signed informed consent.\n3. ECOG Performance Status 0-3.\n4. Expected survival \\> 3 months.\n5. Histopathologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) restricted to the CNS or eyes (PCNSL).\n6. Measurable lesion on contrast-enhanced MRI (\\>10x10 mm) or positive CSF cytology for leptomeningeal disease.\n7. No prior systemic treatment for lymphoma (corticosteroids excepted).\n8. Adequate bone marrow and organ function (ANC \\>=1.5x10\\^9\u002FL, PLT \\>=80x10\\^9\u002FL, Hb \\>=80 g\u002FL; Bilirubin \\\u003C=1.5xULN, AST\u002FALT \\\u003C=2.5xULN; Creatinine \\\u003C=1.5xULN or CrCl \\>=60 mL\u002Fmin) .\n9. Stable controlled comorbidities allowed (e.g., hypertension with blood pressure \\\u003C=160\u002F100 mmHg, type 2 diabetes with HbA1c \\\u003C=8%, mild coronary heart disease without myocardial infarction in the past 6 months).\n10. Basic communication ability to complete PROs questionnaires (no severe cognitive impairment).\n11. Reproductive-aged females and males with childbearing potential: No pregnancy plans during the study and 3 months after treatment discontinuation; use effective contraception (abstinence, physical contraception, or hormonal contraceptives initiated \\>=3 months before first dose). Males prohibited from donating sperm during treatment and 3 months after discontinuation.\n12. For Observational Cohort (Palliative Care Subgroup only): Pathologically confirmed DLBCL restricted to the CNS or eyes; Follow-up available for efficacy assessment (at least one CR evaluation) .\n\nExclusion Criteria:\n\n1.Prior treatment with PD-1\u002FPD-L1 inhibitors or CTLA4 monoclonal antibodies. Uncontrolled active infection. 2.Uncontrolled or significant cardiovascular diseases: 3.Congestive heart failure (NYHA class III\u002FIV),\n\n1. myocardial infarction, unstable angina within 6 months before first dose; arrhythmia requiring treatment; LVEF \\\u003C50%.\n2. Primary cardiomyopathy.\n3. History of clinically significant QTc prolongation, second-degree type II\u002Fthird-degree atrioventricular block, or QTc interval (Fridericia method) \\>470 msec (females) \u002F \\>480 msec (males).\n4. Atrial fibrillation (EHRA grade ≥2b).\n5. Refractory hypertension. 4.Active hepatitis B\u002FC infection (HBV-DNA ≥ detection limit, HCV RNA positive) or syphilis. (Exceptions: HBV-DNA \\\u003C detection limit, cured HCV).\n\n5.HIV infection. 6.Prior organ transplantation or allogeneic stem cell transplantation. 7.Pregnant or lactating females. 8.Prior\u002Fcurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or radiation pneumonitis (unsuitable for study per investigator).\n\n9.Autoimmune diseases requiring systemic treatment within 2 years. 10.For Observational Cohort (Palliative Care Subgroup only): Incomplete clinical data (e.g., no pathological report, inability to perform MRI\u002FPET-CT assessment).",{"count":193,"type":22},77,[25],"The goal of this clinical trial is to evaluate the efficacy and safety of a four-drug combination regimen as first-line treatment for adults aged 18 years and older with newly diagnosed primary central nervous system lymphoma (PCNSL). The main questions it aims to answer are:\n\nDoes the combination of pirtobrutinib, sintilimab, rituximab, and high-dose methotrexate achieve a higher complete response rate than standard treatment for newly diagnosed PCNSL? What is the safety and tolerability profile of this four-drug combination regimen? Researchers will compare the experimental four-drug combination to investigator-selected standard-of-care regimens (all based on high-dose methotrexate) to see if the experimental regimen improves complete response rate, progression-free survival, and overall survival while maintaining an acceptable safety profile.\n\nParticipants will:\n\nBe assigned to either the experimental group or the standard treatment group based on their personal preference Receive 6 cycles of induction therapy (21 days per cycle) with their assigned treatment regimen Undergo regular clinical assessments, including contrast-enhanced brain MRI scans, blood tests, and cerebrospinal fluid examinations Complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, mid-treatment, end of treatment, and follow-up visits Receive optional consolidation or maintenance therapy based on their response to induction treatment Be followed for up to 2 years after completing treatment to monitor for disease progression and long-term outcomes",[197,198],"PCNSL","Primary Central Nervous System Lymphoma",[200,201,202,203,204,205],"Primary Central Nervous System Lymphoma (PCNSL)","Methotrexate","Rituximab","Sintilimab","Pirtobrutinib","Real-World Evidence","2026-05-30",{"date":176,"type":33},{"date":209,"type":33},"2025-12-25",{"date":211,"type":22},"2029-06-30",{"name":39,"class":40},4,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100639839","phase-2-study-on-the-effect-of-oral-diammonium-glycyrrhizinate-in-attenuating-toxicity-and-enhancing-efficacy-of-car-t-cell-therapy-100639839","NCT07616271","Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy","A Single-Center, Prospective, Randomized Controlled Clinical Study of Oral Diammonium Glycyrrhizinate for Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients diagnosed with large B-cell lymphoma and receiving CAR-T cell therapy.\n3. Adequate organ function prior to enrollment: ALT and AST ≤ 2.5 × ULN (upper limit of normal); may be extended to ≤5 × ULN in patients with liver involvement; serum total bilirubin \\\u003C 34 μmol\u002FL; creatinine clearance \\> 30 mL\u002Fmin; cardiac ejection fraction (EF) ≥ 40%, with no pericardial effusion or significant arrhythmia; room air SpO₂ ≥ 92%.\n4. No central nervous system involvement of lymphoma confirmed by MRI prior to enrollment.\n5. Subjects of childbearing potential must agree to use highly effective contraceptive methods.\n6. The subject or their legal guardian must be able to understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Presence of a prior malignancy (other than the disease under study) that requires ongoing systemic treatment for any other malignant tumor.\n2. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's judgment, may compromise patient safety or interfere with the interpretation of safety or efficacy data.\n3. Current or prior central nervous system (CNS) involvement by malignancy.\n4. Receipt of allogeneic stem cell transplantation within 6 months prior to enrollment, or autologous stem cell transplantation within 3 months prior to enrollment; and the patient must have no signs or symptoms of graft-versus-host disease and must not be receiving immunosuppressive therapy.\n5. Intolerance or allergy to glycyrrhizic acid preparations.\n6. Patient refuses to comply with the study requirements to complete the research work.\n7. In the investigator's judgment, the patient is unable to complete the study or comply with the study requirements (due to administrative reasons or other reasons), or is considered unsuitable for clinical trial participation for other reasons.",{"count":222,"type":22},21,[25,224],"PHASE3","The purpose of this study is to evaluate the effect of oral diammonium glycyrrhizinate in reducing toxicity and enhancing efficacy of CAR-T cell therapy in patients with large B-cell lymphoma. Two main questions are addressed: 1) Can oral diammonium glycyrrhizinate reduce the incidence and severity of CRS induced by CAR-T cells? 2) Can oral diammonium glycyrrhizinate synergistically increase the therapeutic efficacy of CAR-T cell therapy?",[227],"Patients With Large B-cell Lymphoma Receiving CAR-T Cell Therapy",[229,230,231,232],"Large B-cell lymphoma","Diammonium Glycyrrhizinate","CAR-T cell therapy","Toxicity reducing and efficacy enhancing","2026-05-29",{"date":235,"type":33},"2026-06-01",{"date":237,"type":22},"2026-05-22",{"date":239,"type":22},"2030-05-31",{"name":39,"class":40},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},"100637489","somatostatin-plus-clear-liquid-diet-versus-diverting-stoma-in-patients-with-rectal-cancer-undergoing-ultra-low-anterior-resection-100637489","NCT07605611","Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection","A Multicenter, Randomized Clinical Study of Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Low and Mid Rectal Cancer Undergoing Ultra-Low Anterior Resection","SC-Stoma","Inclusion Criteria:\n\n1. Adults aged 18 to 75 years\n2. Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center\n3. The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination\n4. The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge\n5. Patients have two or more risk factors for anastomotic leakage as assessed by the study team\n6. American Society of Anesthesiologists physical status classification is grade 3 or lower\n7. Body mass index is less than 30 kg\u002Fm²\n8. The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Has another colorectal malignant tumor at the same time\n2. The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge\n3. Has metastatic disease before surgery\n4. Is pregnant\n5. Has a mental illness or addictive disorder that would prevent participation in the clinical trial\n6. Requires emergency surgery\n7. Has inflammatory bowel disease\n8. Is allergic to somatostatin or is unable to tolerate somatostatin\n9. For participants assigned to the no-stoma group, the surgeon decides that a stoma is required\n10. Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery\n11. Has any other condition that makes it impossible to follow the study protocol",{"count":250,"type":22},72,[73],"The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. These patients have a higher risk of leakage where the bowel is joined together after surgery.\n\nThe main questions it aims to answer are:\n\nDoes somatostatin plus a clear liquid diet prevent severe leakage within 1 month after surgery about as well as a prophylactic diverting stoma?\n\nWhat medical problems, bowel function problems, recovery outcomes, and quality of life outcomes do participants have after surgery and during follow-up?\n\nResearchers will compare somatostatin plus a clear liquid diet without a diverting stoma to prophylactic diverting stoma to see if the somatostatin plus clear liquid diet regimen can provide similar protection against severe leakage while reducing the need for stoma creation.\n\nParticipants will:\n\nHave rectal cancer surgery with the bowel joined very close to the anus\n\nBe randomly assigned to receive either somatostatin plus a clear liquid diet for 7 days after surgery without a diverting stoma, or a prophylactic diverting stoma\n\nHave follow-up assessments of leakage, postoperative complications, bowel function, recovery quality, and quality of life\n\nComplete follow-up visits or assessments for up to 3 years after surgery",[254,255],"Rectal Cancer","Anastomotic Leakage",[257,258,259,260,261,262,263,264,265,266],"Rectal cancer","Ultra-low anterior resection","Anastomotic leakage","Severe anastomotic leakage","Diverting stoma","Prophylactic stoma","Somatostatin","Clear liquid diet","Bowel function","Quality of life",{"date":268,"type":33},"2026-05-26",{"date":270,"type":33},"2025-11-17",{"date":272,"type":22},"2030-06-30",{"name":39,"class":40},3,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":281,"minAge":282,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":274},"100639265","phase-4-clinical-efficacy-study-of-jinfeng-pill-in-the-treatment-of-perimenopausal-syndrome-100639265","NCT07606755","Clinical Efficacy Study of Jinfeng Pill in the Treatment of Perimenopausal Syndrome","Inclusion Criteria:\n\n1. Female patients aged 45-55 years;\n2. Menstrual disorders (prolonged menstrual cycle or hypomenorrhea) lasting for more than 3 months, or amenorrhea for 2-12 months;\n3. Presence of vasomotor symptoms (hot flashes, sweating), somatic symptoms (insomnia, fatigue, headache, paresthesia), psychological symptoms (anxiety, depression), or urogenital symptoms (dyspareunia, vaginal dryness, urinary tract infection);\n4. Serum follicle-stimulating hormone (FSH) \\> 10 IU\u002FL, or decreased estradiol (E2) levels;\n5. No use of HRT or other medications for perimenopausal symptoms in the past 2 months;\n6. Intact uterus and bilateral adnexa, not surgically removed;\n7. Voluntary participation and signing of informed consent;\n8. Modified Kupperman Index (KI score) ≥ 6, indicating mild or above symptoms.\n\nExclusion Criteria:\n\n1. Does not meet the inclusion criteria listed above;\n2. Ovarian malignancy, ovarian or hysterectomy, premature ovarian failure, uterine fibroids ≥2 cm, severe breast hyperplasia;\n3. Acute gynecological infectious diseases or other acute infectious diseases;\n4. Severe liver or kidney dysfunction, or other serious systemic diseases;\n5. Use of hormonal drugs or traditional Chinese medicine for treatment in the past 2 months;\n6. Participation in other clinical trials;\n7. Patients who did not adhere to the treatment protocol or withdrew from the trial;","FEMALE","45 Years","55 Years",{"count":285,"type":22},100,[287],"PHASE4","Perimenopausal syndrome (PMS) is a common condition affecting women during the transition to menopause, often causing hot flashes, sweating, insomnia, anxiety, depression, fatigue, and reduced quality of life. Current hormone replacement therapy can improve symptoms, but long-term use may increase the risk of breast cancer and cardiovascular complications. Therefore, safer and more effective alternative treatments are needed.\n\nJinfeng Pill is a traditional Chinese medicine patented drug that has been widely used in gynecological disorders. Previous studies suggest that it may help regulate hormone balance, improve ovarian function, and reduce inflammation. Recent research has also shown that intestinal bacteria (\"gut microbiota\") may influence estrogen metabolism through the \"gut microbiota-estrogen axis,\" which could play an important role in perimenopausal symptoms.\n\nThis study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of Jinfeng Pill in women with perimenopausal syndrome. Eligible participants will be randomly assigned to receive either Jinfeng Pill or a placebo for 12 weeks. Researchers will assess changes in menopausal symptoms, mood, sleep, and quality of life using standardized questionnaires and laboratory tests.\n\nIn addition, the study will explore how Jinfeng Pill may regulate gut microbiota, β-glucuronidase (β-GUS) activity, short-chain fatty acids (SCFAs), inflammatory factors, and estrogen-related indicators. The findings may provide new evidence for the clinical use of traditional Chinese medicine in the treatment of perimenopausal syndrome and help clarify its underlying biological mechanisms.",[290],"Perimenopausal Syndrome",[290,292],"Jinfeng Pill","2026-05-18",{"date":268,"type":33},{"date":296,"type":22},"2026-05-10",{"date":298,"type":22},"2028-05-01",{"name":39,"class":40},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":41},"100633285","a-study-about-remote-and-local-liver-surgery-100633285","NCT07524699","A Study About Remote and Local Liver Surgery","Efficacy and Safety of MP1000 System in Remote and Local Liver Surgery: A Prospective, Multicenter, Single-blind, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age range: 18-75 years old (inclusive), gender not restricted;\n2. BMI: 18-30 Kg\u002Fm2;\n3. Relevant indications for liver surgery;\n4. Physiological condition allows for laparoscopic surgery, and the Iwate score for laparoscopic difficulty of the enrolled patients is ≤ 6;\n5. Willing to cooperate and complete follow-up and related subsequent examinations;\n6. Voluntary to sign the informed consent form;\n7. Indocyanine green 15-minute retention rate (ICG-R15) \\\u003C 15%, and liver function Child-Pugh grade is A.\n\nExclusion Criteria:\n\n1. Patients with severe circulatory system diseases who cannot tolerate surgery;\n2. Pregnant or lactating women;\n3. Patients with a history of epilepsy or mental illness;\n4. Patients with severe allergic constitution and those suspected or diagnosed with alcohol or drug addiction;\n5. Patients who cannot understand the research requirements or who cannot complete the research follow-up;\n6. Patients considered unsuitable to participate in this trial by the researchers.",{"count":308,"type":22},148,[73],"The goal of this clinical trial is to learn if the robotic surgical system producted by Shenzhen Edge Medical Company has a non-inferior textbook outcome in liver surgery in the field of remote surgery compared to local robotic surgery. It will also learn about the safety of remote liver surgery.\n\nThe main questions are: Does remote liver surgery not lower the textbook outcomes in liver surgery compared to the local robotic surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local robotic liver surgery to see if remote liver surgery doesn't lower the textbook outcome in liver surgery.\n\nParticipants will:\n\nUndergo remote or local robotic liver surgery according to the random program; Visit the clinic in 3, 28 and 42 day after surgery for checkups and tests; Keep a diary of their postoperative complications.",[312],"Liver Diseases",[314,315,316],"Remote Surgery","Liver Surgery","Randomized controlled trial","2026-05-13",{"date":293,"type":33},{"date":320,"type":22},"2026-05-16",{"date":322,"type":22},"2028-07-31",{"name":39,"class":40},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":281,"minAge":18,"maxAge":19,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":41},"100593123","phase-3-invigorate-a-study-of-ql1706-and-bevacizumab-in-advanced-first-line-ovarian-clear-cell-carcinoma-100593123","NCT07002346","INVIGORATE: A Study of QL1706 and Bevacizumab in Advanced First-Line Ovarian Clear Cell Carcinoma","A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Trial Evaluating QL1706 With Bevacizumab Versus Standard Platinum-Based Chemotherapy With or Without Bevacizumab as First-line Treatment for Advanced Ovarian Clear Cell Carcinoma","INVIGORATE","Inclusion Criteria:\n\n* Voluntary participation in the study and signed informed consent form.\n* Age ≥ 18 years and \\\u003C 75 years, female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected survival ≥ 3 months.\n* Histologically or cytologically newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma.\n* Patients are planned to undergo primary debulking surgery (PDS), regardless of whether satisfactory debulking is achieved, and have complete surgical records and residual disease assessment results (R0 vs R1\u002FR2).\n* No prior first-line postoperative systemic antitumor therapy for the current ovarian clear cell carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc.\n* Adequate organ function confirmed by the following requirements:\n\nHematological (no use of any blood components or cell growth factors within 7 days prior to initiation of study treatment):\n\ni. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (1,500\u002Fmm\\^3). ii. Platelet count ≥ 100 × 10\\^9\u002FL (100,000\u002Fmm\\^3). iii. Hemoglobin ≥ 90 g\u002FL.\n\nRenal:\n\ni. Calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin. CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL\u002Fmin) = \\[(140 - age) × weight (kg) × F\\] \u002F \\[SCr (mg\u002FdL) × 72\\], where F = 0.85 for females and SCr = serum creatinine.\n\nii. Urine protein \\\u003C 2+ or 24-hour quantitative urine protein \\\u003C 1.0 g.\n\nHepatic:\n\ni. Total serum bilirubin (TBil) ≤ 1.5 × ULN. ii. AST and ALT ≤ 2.5 × ULN.\n\nCoagulation:\n\ni. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n\\- For women of childbearing potential, a negative serum or urine pregnancy test within one week prior to enrollment, and effective contraceptive measures must be used after enrollment, for example, use of physical barrier contraception (condoms) or complete abstinence. Oral, injectable, or implantable hormonal contraceptives are not permitted. Or, women of non-childbearing potential, defined as: i. Naturally postmenopausal for at least 1 year. ii. Surgically sterile, including bilateral oophorectomy, bilateral salpingectomy, or hysterectomy.\n\niii. Serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels within the postmenopausal range for the study center's laboratory.\n\n* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.\n* Patient is willing to cooperate in completing quality of life questionnaires during the trial treatment and follow-up period, and agrees that these questionnaire results can be used for clinical research.\n\nExclusion Criteria:\n\n* Histologically confirmed ovarian cancer of other epithelial origin or non-epithelial origin, other than ovarian clear cell carcinoma; ovarian tumors of low malignant potential, such as borderline tumors.\n* Prior systemic preoperative antitumor therapy for the current ovarian clear cell carcinoma, including but not limited to neoadjuvant chemotherapy (NACT) or other types of neoadjuvant therapy, or planned neoadjuvant therapy followed by interval debulking surgery (IDS) during screening.\n* Prior treatment with immune checkpoint inhibitors, such as PD-1\u002FPD-L1 antibodies, or drugs targeting other T-cell receptors, such as CTLA-4, as well as immune checkpoint agonist antibodies, such as anti-ICOS, CD40, CD137, GITR, or OX40 antibodies, and immune cell therapy.\n* Systemic use of corticosteroids or other immunosuppressive drugs, such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or TNFα inhibitors, within 2 weeks before the first dose. Note: Inhaled or topical steroids, steroids as premedication for hypersensitivity reactions, such as CT scan contrast agent premedication or cytotoxic chemotherapy premedication, or adrenal replacement steroids, daily ≤10 mg prednisone or equivalent, are permitted in the absence of active autoimmune disease.\n* Prior, within 5 years, or concurrent malignancies, with the exception of cured local tumors, such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc., and breast cancer with no recurrence \\>3 years after radical surgery.\n* Patients with contraindications to bevacizumab, including but not limited to prior gastrointestinal perforation, surgery within 28 days before medication or incompletely healed wounds, severe bleeding or recent hemoptysis, or other situations where the investigator deems bevacizumab unsuitable.\n* Receipt of live vaccine within 30 days before the first dose of study treatment, persisting until 90 days after the last dose of study treatment. Note: Live vaccines include but are not limited to measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza virus vaccines not containing live virus, inactivated COVID-19 vaccines, etc., are permitted.\n* Active autoimmune disease requiring systemic treatment, such as use of disease-modifying drugs, corticosteroids, or immunosuppressants, within 2 years before the first dose. Replacement therapies, such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, are not considered systemic treatment. Note: Patients with cataracts, Graves' disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded.\n* Systemic infection requiring systemic antibiotic treatment or other severe infections within 2 weeks before randomization, or unexplained fever \\>38.0°C during the screening period or before enrollment, and inability to discontinue aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for more than 5 days.\n* Severe illness or concomitant non-tumor diseases, such as neurological disorders, psychiatric disorders, infectious diseases, or laboratory abnormalities, that may increase the risk of participating in the study or taking study drugs, and which the investigator deems would make the patient unsuitable for the study.\n* Pregnant or lactating women.\n* Clinically significant cardiovascular diseases, including but not limited to:\n\n  1. Myocardial infarction or unstable angina within 6 months before the first dose.\n  2. Stroke or transient ischemic attack within 6 months before the first dose.\n  3. Hypertension not controlled by optimal antihypertensive therapy, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg.\n  4. Poorly controlled arrhythmias. Patients who have stabilized before the first dose and have been stable for ≥14 days may be enrolled.\n  5. Congestive heart failure, New York Heart Association (NYHA) functional class II-IV.\n  6. Myocarditis.\n* Expectation of needing any other form of anti-tumor therapy during the study period.\n* Receipt of traditional Chinese medicines with anti-tumor indications or immunomodulatory drugs, including but not limited to thymosin, interferon, interleukin-2, etc., within 2 weeks before the first dose.\n* HIV-positive patients.\n* Known history of anti-tuberculosis treatment within one year before the first administration of study treatment.\n* Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) ≥2000 IU\u002FmL or 10\\^4 copies\u002FmL; HCV antibody positive and HCV RNA positive.\n* Pre-existing peripheral neuropathy of grade ≥2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.\n* Current or recent, within 10 days before the first dose of study drug, continuous use of full-dose oral or parenteral anticoagulants or thrombolytic agents for 10 days. Note: Prophylactic use of low-dose anticoagulants is permitted, including low-dose warfarin (≤1 mg\u002Fday), low-dose heparin (≤12,000 U\u002Fday), or low-dose aspirin (≤100 mg\u002Fday), provided the prothrombin time international normalized ratio (INR) is ≤1.5.\n* Hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis, or imaging showing tumor invasion\u002Finfiltration of major blood vessels, or investigator or radiologist assessment of bleeding tendency.\n* Known history of severe allergy to macromolecular protein preparations, or to any component of QL1706 or other investigational drugs, or severe allergic history to chemotherapeutic drugs such as carboplatin, paclitaxel, nab-paclitaxel, or their premedications.\n* Currently participating in interventional clinical research treatment, or receiving any other investigational drug or research device treatment within 4 weeks before the first dose. Patients who failed screening for other clinical trials may be included in this study.\n* Patients deemed unsuitable for participation in this study by the investigator.",{"count":333,"type":22},226,[224],"The goal of this phase 3 clinical trial is to evaluate whether QL1706 plus bevacizumab can effectively treat adult female patients (18 to \\\u003C75 years old) with newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. The main questions it aims to answer are:\n\n1. Does QL1706 plus bevacizumab, compared with standard platinum-based chemotherapy with or without bevacizumab, prolong patients' progression-free survival (PFS)?\n2. What is the safety profile of QL1706 followed by QL1706 plus bevacizumab, such as what medical problems (adverse events) do participants experience?\n\nResearchers will compare QL1706 followed by QL1706 plus bevacizumab (experimental arm) with standard platinum-based chemotherapy consisting of paclitaxel plus carboplatin with or without bevacizumab (control arm) to see whether QL1706-based immunotherapy is more effective in the first-line treatment of advanced ovarian clear cell carcinoma.\n\nParticipants will:\n\n1. Be randomly assigned to receive either QL1706 alone during Cycle 1 followed by QL1706 plus bevacizumab from Cycle 2, or paclitaxel plus carboplatin with or without bevacizumab according to prespecified high-risk criteria.\n2. Visit the research center regularly for drug infusions, medical examinations (such as vital signs, physical exams, laboratory tests), and tumor imaging assessments.\n3. Complete quality of life questionnaires as required.",[337],"Ovarian Clear Cell Carcinoma",[337,339,340,341,342],"QL1706","Bevacizumab","First-line treatment","Immunotherapy",{"date":293,"type":33},{"date":345,"type":33},"2025-11-15",{"date":347,"type":22},"2029-06-01",{"name":39,"class":40},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":281,"minAge":4,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":358,"conditions":359,"keywords":363,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":379,"locationsCount":41},"100638338","prospective-sample-collection-study-for-a-blood-based-cfdna-methylation-assay-for-ovarian-cancer-detection-100638338","NCT07593833","Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection","Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer","Inclusion Criteria:\n\n* Female participants.\n* Participants with an ovarian\u002Fadnexal mass who are planned to undergo, for the first time at the current center, surgery or biopsy\u002Fpathologic sampling related to the current lesion, with an expected pathologic diagnosis available as the reference standard.\n* Imaging evaluation during screening suggests a unilateral or bilateral, unilocular or multilocular cystic-solid or solid ovarian\u002Fadnexal mass requiring differential diagnosis.\n* An adequate peripheral blood sample can be collected before the first surgery or before initiation of any systemic anti-tumor treatment for the current ovarian\u002Fadnexal mass, and the sample can be processed and stored within the required time according to the unified study procedures.\n* Clinical data and postoperative pathologic results are expected to be sufficiently complete to provide key information for subsequent analyses.\n* The participant or her legally authorized representative voluntarily signs written informed consent after being fully informed.\n\nExclusion Criteria:\n\n* The participant has already received systemic anti-tumor treatment for the current ovarian\u002Fadnexal lesion under evaluation, such as chemotherapy, targeted therapy, immunotherapy, or radiotherapy, or has already undergone definitive tumor resection or comprehensive staging surgery, and is undergoing surgery only for residual or recurrent lesions.\n* No pathologic diagnosis is ultimately obtained for the current ovarian\u002Fadnexal mass, or no analyzable pathologic conclusion can be established.\n* Imaging findings at screening are highly typical of benign mature cystic teratoma.\n* Ovarian cancer combined with another malignant tumor.\n* There are obvious noncompliances during sample collection, transport, or processing, resulting in severe hemolysis, contamination, or seriously insufficient sample volume, such that the sample cannot meet quality control requirements for cfDNA methylation testing or subsequent analyses.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.",{"count":357,"type":22},1000,"The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are:\n\nHow well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes?\n\nResearchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay.\n\nParticipants will:\n\nProvide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis",[360,361,362],"Ovarian Neoplasms","Ovarian Cancer","Early Detection of Cancer",[361,360,364,365,366,367,368,369,370,371,372,373],"cfDNA Methylation","Cell-Free DNA","DNA Methylation","Liquid Biopsy","Blood-Based Assay","Early Detection","Biomarker","Early Diagnosis","Diagnostic Performance","Ovarian Tumor","2026-05-12",{"date":293,"type":33},{"date":37,"type":22},{"date":378,"type":22},"2029-12-30",{"name":39,"class":40},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":398,"locationsCount":399},"100631856","dose-effect-response-in-acupuncture-for-functional-constipation-100631856","NCT07506122","Dose-Effect Response in Acupuncture for Functional Constipation","Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study","Inclusion Criteria:\n\n* Meet Rome IV diagnostic criteria for functional constipation\n* Symptoms present for ≥6 months, meeting diagnostic criteria in the last 3 months\n* Mean weekly complete spontaneous bowel movements (CSBMs) ≤2 during 14-day baseline period\n* Age 18-75 years\n* No use of constipation medications for at least 2 weeks prior to treatment (except rescue medication)\n* No acupuncture treatment for constipation in the past 3 months\n* Not currently participating in another clinical trial\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Constipation secondary to other causes (IBS, organic diseases, medications, endocrine disorders, metabolic disorders, neurological disorders, or gastrointestinal surgery)\n* Loose or watery stools (Bristol type 6 or 7) \\>1 time during baseline without laxative use\n* History of pelvic floor dysfunction\n* Use of probiotics, fiber supplements, or laxatives within 2 weeks prior to treatment (2-week washout required)\n* Severe hemorrhoids or anal fissures\n* Severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; hepatosplenomegaly; cognitive impairment; or psychiatric disorders\n* Dependence on opioids or anticholinergic drugs\n* Red flags: unexplained weight loss \\>10% in 3 months, hematochezia or positive fecal occult blood, family history of colon cancer (first-degree relative diagnosed \\\u003C50 years), anemia (Hb \\\u003C110 g\u002FL), or elevated inflammatory markers\n* Contraindications to acupuncture: coagulation disorders or use of anticoagulants\n* Pregnancy or breastfeeding\n* Unable to comply with follow-up or contraindications to MRI (e.g., cardiac pacemaker, non-titanium aneurysm clips, metallic implants, claustrophobia)",{"count":250,"type":22},[73],"This is a single-center, randomized, parallel-group trial evaluating the dose-response relationship of two experimental interventions: manual acupuncture and electroacupuncture for functional constipation.\n\nA total of 72 participants with functional constipation (Rome IV criteria) will be randomly assigned in a 1:1 ratio to either the manual acupuncture group or the electroacupuncture group. Both groups receive acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37) points, 30 minutes per session, three times per week for 12 weeks. The electroacupuncture group additionally receives electrical stimulation (continuous wave, 10 Hz, 0.5-4 mA).\n\nThe primary outcome is the responder rate at week 12, defined as the percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week. Secondary outcomes include changes in gut microbiota, brain functional connectivity measured by multimodal MRI and fNIRS, and scales.\n\nThe study aims to clarify the dose-response characteristics of different acupuncture modalities and their underlying biological mechanisms.",[391],"Functional Constipation (FC)","2026-05-11",{"date":394,"type":33},"2026-05-14",{"date":392,"type":33},{"date":397,"type":22},"2027-12",{"name":39,"class":40},2,{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":41},"100633423","phase-1-safety-and-pharmacodynamics-of-qh103-cell-injection-in-the-treatment-of-patients-with-relapsedrefractory-antibody-mediated-neurological-autoimmune-diseases-100633423","NCT07526493","Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed\u002FRefractory Antibody-Mediated Neurological Autoimmune Diseases.","An Open-Label Clinical Study to Evaluate the Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed\u002FRefractory Antibody-Mediated Neurological Autoimmune Diseases.","Common Inclusion Criteria:\n\n1. Aged 18-75 years (inclusive), any gender.\n2. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or practice abstinence during the study treatment period and for at least 6 months after the end of the study treatment. Female subjects of childbearing potential must have a negative serum HCG test within 7 days before study enrollment and must not be breastfeeding.\n3. The subject's expected survival, as judged by the investigator, is ≥12 weeks.\n4. Voluntarily participate in this trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\n1、Multiple Sclerosis (MS): Clinically confirmed as progressive MS (including Primary Progressive PPMS or Secondary Progressive SPMS) or Relapsing-Remitting MS (RMS) according to the revised 2017 McDonald criteria. Disability status at screening must meet an EDSS score of 2-7 (inclusive) .For participants with RMS, despite standardized use of DMTs, they must have documented evidence meeting one of the following conditions prior to signing the informed consent:\n\n1. Two relapses were recorded within the first 2 years of screening;\n2. One recurrence was recorded within the first year prior to screening;\n3. Select the results of Gd-enhanced MRI scans that were positive within the previous year (if there is no record of a positive Gd-enhanced scan in the previous year, the results of the screening MRI scan can be used).\n\n2、Neuromyelitis Optica Spectrum Disorder (NMOSD): Participants with AQP4 antibody-positive NMOSD meeting the 2015 IPND NMOSD diagnostic criteria, and meeting one of the following:\n\n1. Treatment with at least one immunosuppressant for over 1 year, or intolerance to immunosuppressant treatment, with suboptimal symptom control.\n2. At least 2 documented relapses within the last 12 months, or 3 documented relapses within the last 24 months with at least 1 relapse occurring within the 12 months prior to screening.\n\n3、Autoimmune Encephalitis (AE): Participants with a clinical diagnosis of Autoimmune Encephalitis based on the 2016 International Diagnostic Criteria, meeting all of the following requirements:\n\n1. Positive for at least one relevant autoantibody;\n2. Inadequate symptom control with or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant\u002Fimmunomodulator (including CD20 monoclonal antibody);\n3. An episode of autoimmune encephalitis within 3 months prior to signing the informed consent form;\n4. Disability status at screening meeting a modified Rankin Scale (mRS) score ≥ 2 or a CASE score ≥ 4 .\n\n4、Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Participants diagnosed with antibody-positive CIDP according to the 2021 EAN\u002FPNS diagnostic criteria, with an INCAT Disability Scale total score between 2 and 9, and meeting one of the following:\n\n1. Inadequate symptom control despite standardized use of at least one first-line therapy (corticosteroids, intravenous immunoglobulin, or plasma exchange) for over 3 months;\n2. Intolerance to corticosteroids, intravenous immunoglobulin, and plasma exchange due to side effects or other reasons.\n\n5、Myasthenia Gravis (MG): Participants diagnosed with antibody-positive MGFA Class II-IV Myasthenia Gravis according to the 2020 MGFA diagnostic criteria, with a Myasthenia Gravis Activities of Daily Living (MG-ADL) profile (Appendix 6) total score ≥ 6, and meeting one of the following:\n\n1. Standardized treatment with at least one immunosuppressant for over 1 year, with one of the following indicating inadequate control: (1) persistent weakness affecting daily life, (2) worsening MG symptoms and\u002For crisis episodes despite standard treatment, or (3) intolerance to immunosuppressant therapy;\n2. Requiring maintenance therapy with plasma exchange or intravenous immunoglobulin.\n\n6、Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody----- - Associated Disease (MOGAD): Participants with a clinical diagnosis of MOGAD based on the 2023 International MOGAD Diagnostic Criteria, meeting all of the following:\n\n1. Positive for MOG autoantibody via cell-based assay (CBA);\n2. Disability status at screening meeting a modified Rankin Scale (mRS) score ≥ 2.\n3. Inadequate symptom control with or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant \u002F immunomodulator (including CD20 monoclonal antibody).\n\n7、Idiopathic Inflammatory Myopathies (IIM): Patients clinically diagnosed with refractory, antibody-positive Idiopathic Inflammatory Myopathy (IIM) based on the 2017 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria. At screening, at least one muscle enzyme (CK, AST, ALT, ALD, LDH) must be ≥1.5 times the upper limit of normal (ULN); OR the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) for dermatomyositis must be ≥6 (Appendix 7); OR there must be evidence of active myositis within the last 6 months from at least one of the following: MRI, electromyography, or muscle biopsy. The patient must test positive for at least one myositis-specific antibody (MSA), myositis-associated antibody (MAA), or antinuclear antibody (ANA). Additionally, they must meet one of the following criteria:\n\n1. Treatment with corticosteroids for at least 1 month, combined with standardized use of at least one immunosuppressant\u002Fimmunomodulator (e.g., azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, leflunomide, intravenous immunoglobulin, etc.) for over 3 months, resulting in inadequate symptom control.\n2. Intolerance to the aforementioned conventional treatment regimens due to side effects or other reasons.\n\nExclusion Criteria:\n\n1. History of severe drug allergy or allergic diathesis.\n2. Presence of or suspected uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n3. Organ function that does not meet the following requirements (except for abnormalities caused by the autoimmune disease itself):\n\n   1. Bone Marrow Function: White blood cell count ≥1×10⁹\u002FL; absolute neutrophil count ≥1×10⁹\u002FL (no treatment with colony-stimulating factors within 2 weeks prior to the test); hemoglobin ≥60 g\u002FL.\n   2. Liver Function: ALT ≤3×ULN (except if elevated due to inflammatory myopathy); AST ≤3×ULN (except if elevated due to inflammatory myopathy); Indirect bilirubin (IBIL) ≤1.5×ULN (except for Gilbert's syndrome); Total bilirubin ≤3.0×ULN.\n   3. Renal Function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin (eGFR ≥30 mL\u002Fmin\u002F1.73m²) (calculated by Cockcroft-Gault formula, except for acute decreases in CrCl due to the disease itself).\n   4. Coagulation Function: International normalized ratio (INR) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN.\n   5. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥55% and no clinically significant cardiac disease.\n4. Subjects with a history indicative of congenital immunoglobulin deficiency.\n5. History of active\u002Funresolved malignant tumors within the past 5 years.\n6. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the detection limit; positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; or positive for Treponema pallidumserology.\n7. History of definite psychiatric disorders or history of substance abuse involving psychotropic drugs that cannot be discontinued.\n8. Participation in any other clinical trial within 3 months prior to enrollment.\n9. Prior treatment with CAR-T cell therapy.\n10. History of severe adverse reactions to cyclophosphamide or fludarabine.\n11. History of other autoimmune diseases (e.g.,Crohn's disease, systemic lupus erythematosus) that, within the past 2 years, have resulted in end-organ damage or required systemic immunosuppressive therapy (excluding the disease populations specified for enrollment in the study protocol).\n12. Myasthenia gravis crisis not effectively controlled within 2 weeks prior to enrollment.\n13. History of cerebrovascular accident, including transient ischemic attack or stroke, within 6 months prior to enrollment.\n14. Male or female participants unwilling to practice contraception from the time of informed consent until 6 months after treatment completion.\n15. Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment.\n16. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulation therapy.\n17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.",{"count":408,"type":22},6,[410],"PHASE1","This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to \"3+3\" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of recurrent\u002Frefractory antibody-mediated neurological autoimmune diseases.",[413,414,415,416,417,418,419],"Multiple Sclerosis (MS)","Neuromyelitis Optica Spectrum Disorder (NMOSD)","Autoimmune Encephalitis (AE)","Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Myasthenia Gravis (MG)","Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)","Idiopathic Inflammatory Myopathies (IIM)","2026-05-07",{"date":374,"type":33},{"date":423,"type":33},"2026-04-01",{"date":425,"type":22},"2028-12-31",{"name":39,"class":40},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":442,"leadSponsor":444,"locationsCount":41},"100624724","phase-2-tislelizumab-combined-with-huaier-granule-as-first-line-treatment-for-unresectable-hepatocellular-carcinoma-100624724","NCT07413354","Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma","Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Prospective Clinical Trial","Inclusion Criteria:\n\n1. Male or female aged ≥18 years at the time of signing the informed consent form;\n2. Histologically confirmed diagnosis of HCC;\n3. BCLC stage C, or BCLC stage B disease that is unsuitable for locoregional therapy or has progressed after locoregional therapy, and is not eligible for curative treatment;\n4. No prior systemic therapy for HCC. Note: Patients who have previously received local therapy (e.g., TACE) are not excluded;\n5. Presence of ≥1 measurable lesion according to RECIST v1.1, provided that: the selected target lesion(s) have not been previously treated with local therapy, or the selected target lesion(s) are located within an area of prior local treatment and have subsequently been assessed as progressive disease according to RECIST v1.1;\n6. Child-Pugh class A liver function within 7 days prior to randomization;\n7. ECOG performance status ≤1.\n\nExclusion Criteria:\n\n1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma;\n2. Tumor thrombus involving the main portal vein or inferior vena cava;\n3. Prior local liver therapy (e.g., transarterial chemoembolization, transarterial embolization, hepatic arterial infusion, radiotherapy, radioembolization, or ablation) or any immunotherapy (e.g., interleukin, interferon, thymosin, etc.) within 28 days before enrollment;\n4. Use of traditional Chinese medicine or patent drugs for cancer control within 14 days before enrollment;\n5. Grade 2 or higher hepatic encephalopathy at screening or in medical history;\n6. Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening, defined as meeting either of the following criteria: (a) ascites detectable by physical examination at screening, or (b) ascites requiring paracentesis during screening;\n7. History of severe hypersensitivity to other monoclonal antibodies;\n8. Any clinical evidence of portal hypertension with bleeding esophageal or gastric varices during screening or within 6 months before randomization;\n9. Toxicities from prior anticancer therapy have not resolved to baseline or stabilized, except for alopecia;\n10. Any hemorrhagic or thrombotic disease within 6 months before screening, or any anticoagulant therapy requiring monitoring of the international normalized ratio (e.g., warfarin or similar agents);\n11. History of any active malignancy within 2 years before screening, except for HCC under study in this trial and locally recurrent cancers that have been curatively treated (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast);\n12. Known central nervous system metastases and\u002For leptomeningeal disease at screening;\n13. Any active immunodeficiency or autoimmune disease at screening, and\u002For history of any immunodeficiency or autoimmune disease with potential for recurrence;\n14. Any condition requiring systemic corticosteroid therapy (at doses \\>10 mg\u002Fday prednisone or equivalent of similar drugs) or other immunosuppressive treatment within 14 days before screening;\n15. History of interstitial lung disease or non-infectious pneumonia, unless radiation-induced;\n16. Any severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (e.g., tuberculosis), excluding viral hepatitis; known history of human immunodeficiency virus infection;\n17. Presence of underlying medical conditions that, in the investigator's judgment, may pose risks for receiving the study treatment or complicate the interpretation of adverse events\u002Ftoxicity;\n18. History of allogeneic stem cell transplantation or organ transplantation; receipt of any live vaccine within 4 weeks before randomization (Note: seasonal influenza vaccines are generally inactivated and allowed; intranasal vaccines are live and not allowed);\n19. Any major surgery within 28 days before randomization;\n20. Female patients who are lactating.",{"count":435,"type":22},94,[25],"This study is a single-arm prospective clinical trial that enrolled 94 patients with unresectable hepatocellular carcinoma(HCC) who received first-line treatment with tislelizumab combined with Huaier granule. By comparing the objective response rate (ORR) and other data with those from the historical Rational 301 study, the study aims to explore the efficacy and safety of tislelizumab combined with Huaier granule as a first-line treatment for unresectable HCC, as well as its potential to improve patients' quality of life and alleviate HCC-related symptoms.",[439],"Hepatocellular Carcinoma (HCC)",{"date":374,"type":33},{"date":423,"type":33},{"date":443,"type":22},"2027-12-30",{"name":39,"class":40},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":41},"100618912","early-phase-1-cd19bcma-targeted-ucar-t-for-patients-with-neurological-autoimmune-diseases-100618912","NCT07337785","CD19\u002FBCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases","Clinical Study on the Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19\u002FBCMA in Patients With Neurological Autoimmune Diseases","General Inclusion Criteria for All Participants:\n\n1. Patients voluntarily agree to participate in this trial and sign the informed consent form.\n2. Aged ≥ 18 years and ≤ 70 years, regardless of gender.\n3. Organ function and laboratory test requirements:\n\n   1. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for patients with Gilbert's syndrome).\n   2. Renal function: Serum creatinine ≤ 1.5 × ULN OR creatinine clearance rate ≥ 40 ml\u002Fmin.\n   3. Complete blood count: Neutrophil count ≥ 1 × 10⁹\u002FL; hemoglobin ≥ 60 g\u002FL; platelet count ≥ 20 × 10⁹\u002FL; lymphocyte count \\> 0.3 × 10⁹\u002FL.\n   4. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN OR Prothrombin Time (PT) ≤ 1.5 × ULN.\n   5. Oxygen saturation (SpO₂) ≥ 92% at rest while breathing room air.\n   6. Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n4. For female patients of childbearing potential at screening, the result of serum or urine pregnancy test is negative.\n5. Female of childbearing potential must use effective contraception from at least 28 days before apheresis until 12 months after RD06-05 infusion. Male of reproductive potential must use effective barrier contraception during the same period and must not donate semen or sperm throughout the study.\n\nSpecific Inclusion Criteria for Patients with MS:\n\n1. Diagnosed as Relapsing-Remitting Multiple Sclerosis (RRMS), Primary Progressive Multiple Sclerosis (PPMS), or Secondary Progressive Multiple Sclerosis (SPMS) by a neurologist with diagnostic and treatment qualifications in accordance with the 2017 Revised McDonald Criteria, and relevant diagnostic documents must be provided.\n2. Expanded Disability Status Scale (EDSS) score ranging from 3.0 to 7.5 (inclusive of the cutoff values).\n3. Having undergone a brain MRI examination that meets the 2017 McDonald Criteria within 12 months prior to screening (must include T2\u002FFLAIR and gadolinium-enhanced T1 sequences), showing spatial multiplicity (≥ 2 typical MS lesion regions) and\u002For temporal multiplicity (new T2 or gadolinium-enhanced \\[Gd+\\] lesions).\n4. Previous cerebrospinal fluid (CSF) examination or CSF examination report during the screening period indicating at least one of the following conditions:\n\n   1. Elevated IgG index\n   2. Detection of one or more IgG oligoclonal bands (OCB)\n5. Having received high-efficacy disease-modifying therapy (DMT) for at least 6 months, with the occurrence of any of the following conditions during the treatment period:\n\n   1. Clinically confirmed relapse by a neurologist (new or recurrent persistent neurological deficit lasting ≥ 24 hours, excluding other causes such as fever\u002Finfection)\n   2. EDSS progression (defined as: an increase of ≥ 1.0 point if EDSS ≤ 5.5; or an increase of ≥ 0.5 point if EDSS \\> 5.5) High-efficacy DMTs include but are not limited to: anti-CD20 monoclonal antibodies (e.g., Ocrelizumab), lymphocyte-depleting therapies (e.g., Alemtuzumab, Cladribine), and α4 integrin blockers (e.g., Natalizumab).\n6. RRMS patients must meet one of the following criteria: at least 1 documented relapse within 1 year prior to screening, or at least 2 documented relapses within 2 years prior to screening, or brain MRI indicating active gadolinium-enhanced lesions or new T2 lesions within 1 year prior to screening. PPMS or SPMS patients must have documented evidence of disability progression within 2 years prior to screening. All relapses or MRI activity must be supported by medical records (e.g., outpatient\u002Finpatient records, MRI reports, EDSS assessment forms).\n\nSpecific Inclusion Criteria for Patients with MG:\n\n1. Meet the diagnostic criteria for generalized myasthenia gravis (gMG) in line with international myasthenia gravis (MG) consensus guidelines (e.g., the 2020 Myasthenia Gravis Foundation of America \\[MGFA\\] Guidelines).\n2. Classified as MGFA Clinical Class II, III, or IV (per the MGFA Clinical Classification system for myasthenia gravis).\n3. Serological testing at screening shows positivity for acetylcholine receptor antibodies (AChR-Ab), muscle-specific tyrosine kinase antibodies (MuSK-Ab), or low-density lipoprotein receptor-related protein 4 antibodies (LRP4-Ab); or there is a documented history of positivity for AChR-Ab, MuSK-Ab, or LRP4-Ab in previous medical records.\n4. Score of ≥ 6 points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale, with the score related to ocular symptoms accounting for less than 50% of the total score.\n5. Score of ≥ 8 points on the Quantitative Myasthenia Gravis (QMG) Score, with ≥ 4 items each scoring at least 2 points.\n6. Having received at least one of the following treatments prior to screening, with relevant medical documentation provided:\n\n   1. Immunosuppressants (including but not limited to azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, cyclophosphamide, etc.)\n   2. Biologic agents (including but not limited to complement C5 inhibitors, FcRn blockers, etc.).\n7. As judged by the investigator, the subject has received stable current treatment for MG for at least 3 months and has experienced any of the following:\n\n   1. An increase of ≥ 2 points in the total MG-ADL score, with an increase of ≥ 1 point in non-ocular items;\n   2. An increase of ≥ 3 points in the total QMG score, or an increase of ≥ 1 point in each of ≥ 2 non-ocular muscle items;\n   3. Need for increased medication dosage, hospitalization, or emergency intervention due to MG exacerbation.\n\nDefinition of \"stable treatment\":\n\ni). If the subject is taking acetylcholinesterase inhibitors, they must have received treatment with a stable dosage and regimen for at least 2 weeks prior to screening; ii). If the subject is using glucocorticoids, they must have received treatment with a stable dosage and regimen for at least 2 weeks prior to screening; iii). If the subject is receiving biologics, complement inhibitors, or FcRn blockers, they must have received treatment with a stable dosage for at least 4 weeks prior to screening; iv). If the subject is receiving other immunosuppressants or small-molecule targeted therapeutic agents, they must have received treatment with a stable dosage for at least 2 weeks prior to screening; v). If glucocorticoids and\u002For immunosuppressants were discontinued prior to screening due to intolerance or lack of efficacy, the discontinuation must have occurred at least 4 weeks before screening.\n\nSpecific Inclusion Criteria for Patients with CIDP:\n\n1. Diagnosed as progressive or relapsing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) or meeting the criteria for possible CIDP in accordance with the 2021 Guidelines of the European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS), with supporting evidence including at least the following: electrophysiological findings (slowed nerve conduction velocity in ≥ 2 nerves + conduction block\u002Ftemporal dispersion), elevated cerebrospinal fluid (CSF) protein level (\\> 45 mg\u002FdL), nerve root thickening on MRI, or nerve biopsy results (if applicable).\n2. CIDP Disease Activity Status (CDAS) score ≥ 2 at screening.\n3. Inflammatory Neuropathy Cause and Treatment (INCAT) score ≥ 2 at screening: For patients with an INCAT score of 2, the score must be entirely from lower limb function; for patients with an INCAT score ≥ 3, there is no requirement on whether the score comes from upper or lower limbs.\n4. Having received any of the following treatments for at least 3 months, with either the INCAT score improves by \\\u003C 2 points compared to the baseline, or the treatment discontinuation due to adverse reactions:\n\n   1. Intravenous immunoglobulin (IVIG): ≥ 2 g\u002Fkg per course, with at least 2 courses completed;\n   2. Oral prednisone: ≥ 0.5 mg\u002Fkg per day for 3 months;\n   3. Plasma exchange: ≥ 5 sessions per course, with at least 1 course completed;\n   4. FcRn blockers (e.g., Efgartigimod): ≥ 1 full treatment cycle completed.\n5. If receiving glucocorticoid treatment, the subject must have received stable dosage and regimen for at least 2 weeks before screening; if receiving immunosuppressants or small-molecule targeted therapeutic drugs, the subject must have received stable dosage for at least 2 weeks before screening.\n\nInclusion Criteria for AE Patients:\n\n1\\. According to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis (AE), the patient is clinically diagnosed with autoimmune encephalitis and meets all the following requirements: Positive result in the detection of at least one relevant autoantibody; Poor symptom control or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant\u002Fimmunomodulator (including CD20 monoclonal antibody); Occurrence of an autoimmune encephalitis attack within 3 months before signing the informed consent form; At the time of screening, the disability status meets either a modified Rankin Scale (mRS) score of ≥ 2 or a Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score of ≥ 4.\n\nExclusion Criteria:\n\n1. Primary diagnosis of an autoimmune disease different from the study disease, which the investigator believes may confound the efficacy evaluation of the study disease.\n2. Comorbidity with other clinically significant central nervous system (CNS) diseases or pathological changes prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions\u002Fseizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n3. History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart, liver), or planned future transplantation of such organs\u002Fcells.\n4. For MG patients: Uncontrolled myasthenic crisis within 2 weeks prior to screening.\n5. For CIDP patients: Pure sensory CIDP.\n6. Presence of clinically significant cardiovascular dysfunction within 12 months prior to screening, including but not limited to: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, or any ventricular arrhythmia.\n7. Presence of significant pulmonary or cardiac manifestations (e.g., pericarditis, pleural effusion) at screening, which the investigator assesses as making the patient unsuitable for participation in this study.\n8. Patients with severe asthma or chronic obstructive pulmonary disease (COPD); patients with mild or moderate asthma or COPD receiving stable treatment are eligible for enrollment.\n9. History of malignancy within 5 years prior to signing the ICF, except for fully treated or surgically resected non-melanoma skin cancer or carcinoma in situ (e.g., cervical cancer, bladder cancer, breast cancer) with no residual disease.\n10. Pregnant or lactating females.\n11. History of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., 3 or more infections of the same type within the past year).\n12. Active infection requiring systemic treatment (e.g., infectious pneumonia, tuberculosis) within 2 weeks prior to lymphodepletion.\n13. Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) with positive hepatitis B virus (HBV) DNA detection in peripheral blood; positive for hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n14. Vaccination with live-attenuated vaccines within 4 weeks prior to lymphodepletion, or planned vaccination with live-attenuated vaccines during the study.\n15. Receipt of high-dose corticosteroids (prednisone ≥ 60 mg\u002Fday or equivalent dose) within 4 weeks prior to lymphodepletion, or inability to taper prednisone to ≤ 20 mg\u002Fday gradually within 3 days prior to lymphodepletion.\n16. Inability to taper or discontinue background treatment gradually prior to lymphodepletion chemotherapy, as described in Table 3.\n17. Receipt of plasma exchange, immunoadsorption, or intravenous immunoglobulin (IVIG) treatment within 4 weeks prior to screening.\n18. A history of allergy or intolerance to calcineurin inhibitors used previously.\n19. Receipt of renal replacement therapy within 3 months prior to screening, or expected need for renal replacement therapy during the study.\n20. History of drug or alcohol abuse within 1 year prior to screening.\n21. History or evidence of suicidal ideation within 6 months prior to screening, or any suicidal behavior within the previous 12 months, with the investigator determining a significant suicide risk.\n22. Use of other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) prior to screening.\n23. A history of hypersensitivity or life-threatening reactions to any component or formulation of the study drug or study treatment (including lymphodepletion chemotherapy). For detailed information on the components of the study drug, please refer to the Investigator's Brochure (IB).\n24. Any other condition deemed by the investigator to potentially affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.","70 Years",{"count":454,"type":22},36,[456],"EARLY_PHASE1","This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders.\n\nIn this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data.\n\nFor each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.",[459,417,416,415],"Relapsing or Refractory Multiple Sclerosis (MS)",{"date":374,"type":33},{"date":462,"type":33},"2025-12-12",{"date":464,"type":22},"2028-11-01",{"name":39,"class":40},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":481,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":41},"100633286","effects-of-energy-versus-mechanical-surgical-devices-on-postoperative-cough-100633286","NCT07524712","Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough","Preliminary Study on the Associated Mechanisms Between Surgical Instruments and Postoperative Cough","ENERGY-COUGH","Inclusion Criteria:\n\n* Adult patients scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) for partial resection of the right lung and lymph node sampling between 2025 and 2026;\n* Preoperative examination shows that the maximum diameter of the pulmonary lesion is 2 cm or less (T1), with no hilar or mediastinal lymph node metastasis and no evidence of distant metastasis (M0);\n* ASA grade I-III.\n\nExclusion Criteria:\n\n* With a respiratory infection in the past 4 weeks, and with a history of chronic cough, chronic bronchitis, bronchiectasis, asthma, rhinitis, gastroesophageal reflux disease, or allergic rhinitis syndrome;\n* Using angiotensin-converting enzyme inhibitors (ACEI);\n* Severe heart disease;\n* Having a history of lung surgery.",{"count":475,"type":22},248,[73],"Numerous current studies have indicated that transecting the pulmonary plexus nerve as a routine step in radical lung cancer surgery is an independent risk factor for cough hypersensitivity (CH). However, there are significant disagreements in the thoracic surgery community regarding the strategy for managing the vagus pulmonary plexus, primarily because key clinical issues remain unresolved: How do surgical procedures affect the occurrence and development of CH? And how can these procedures be improved?\n\nA large number of published studies have only analyzed \"where to cut\" while neglecting the surgical issue of \"how to cut\". Even with a high level of evidence, the conclusions remain contradictory. This is because doctors' preferences and changes in supply conditions can influence the selection of instruments. Differences in the energy of the instruments can lead to varying degrees and scopes of vagus nerve degeneration and collateral damage to the sympathetic pulmonary plexus, while CH is regulated by both the sympathetic and parasympathetic nervous systems.\n\nThis project intends to explore the correlation between the selection of surgical instruments and the occurrence and development of postoperative CH at the clinical level, providing a reference for optimizing surgical methods and preventing and treating postoperative CH after lung surgery.\n\nThe specific research objectives are: to clarify the correlation through a randomized controlled trial, comparing the patterns and changes in the occurrence and development of postoperative CH between two groups of patients whose autonomic nerve pulmonary plexus was transected using energy-based instruments versus mechanical methods.\n\nOptimize the surgical procedure: Based on the above results, propose a safe, effective, and feasible surgical method to reduce intraoperative damage, prevent postoperative CH, and improve patients' quality of life.\n\nKey problems to be solved: How do surgical operations affect the occurrence and development of CH? How can improvements be made?\n\n1. Clinical issues:\n\n   ① Do energy-based instruments (causing thermal damage, etc.) and mechanical transection (causing physical damage), which lead to varying degrees of vagus nerve injury and collateral sympathetic nerve damage, affect the occurrence and development of postoperative cough hypersensitivity (CH)?\n\n   ② How to optimize surgical operations to reduce the incidence of postoperative CH and improve patients' quality of life?\n2. Correlation mechanisms: How do different instruments and energy modes affect the pathophysiology of nerve injury, degeneration, and repair, and what are the correlation patterns and mechanisms between these and the occurrence and development of CH?",[479,480],"Postoperative Cough","Cough Hypersensitivity Syndrome",[482,483,484,485,486,487],"postoperative cough","persistent cough","surgical instruments","cough hypersensitivity","vagus pulmonary plexus","vagus nerve","2026-05-02",{"date":420,"type":33},{"date":491,"type":22},"2026-09-01",{"date":493,"type":22},"2028-09-01",{"name":39,"class":40},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":502,"maxAge":18,"enrollmentInfo":503,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":521},"100585566","a-clinical-study-of-glycerol-phenylbutyrate-in-chinese-patients-with-urea-cycle-disorders-100585566","NCT06904027","A Clinical Study of Glycerol Phenylbutyrate in Chinese Patients With Urea Cycle Disorders","A Single-arm, Prospective, Multi-center Post-market Clinical Study of Glycerol Phenylbutyrate in Chinese Patients With Urea Cycle Disorders","Inclusion Criteria:\n\n1. Male or female aged 0-18 years;\n2. Subject and\u002For subject's legally authorized representative willing to follow the therapeutic regimen, dietary management and visit plan of the study, and voluntarily signing informed consent form;\n3. Patients with the following subtypes of UCD: Carbamoyl phosphate synthetase I deficiency, Ornithine translocase deficiency, citrullinemia type I, argininosuccinic aciduria, argininemia, and hyperornithinemia-hyperammonemia-homocitrullinuria (HHH) syndrome;\n4. Patients planned to use glycerol phenylbutyrate who have not used it in past 3 months (including at the time of 3 months);\n5. Men with fertility and women of childbearing potential (with menstruation) who are willing to take effective contraceptive measures during the period from the date of signing the informed consent to 1 months after the last dose of the study drug, such as abstinence, condoms, intra-uterine contraceptive devices, and double barrier methods (such as condoms + contraceptive diaphragms). Pregnancy test results must be negative for women of childbearing age within ≤ 7 days before the initial administration of study drug.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any of the active ingredient, including phenylbutyrate (PBA), phenylacetate acid (PAA) and phenylacetyl glutamine (PAGN), or excipients;\n2. Use of any drug known to significantly affect renal clearance (such as probenecid) or increase protein catabolism (such as corticosteroids) or other drugs known to increase blood ammonia levels (such as valproate) within 24 h before the first administration;\n3. Use of other nitrogen-scavenging agent at the same time after enrollment, such as sodium phenylbutyrate and sodium benzoate;\n4. Pregnant or breastfeeding females.\n5. Other reasons, in the opinion of the investigator, that may affect the patient's compliance and safety in participating in the study.","0 Years",{"count":504,"type":22},40,"Urea cycle disorders (UCD) are rare diseases in China, would lead to high mortality and disability, which require long-term management due to the recurrent symptoms. This multi-center, prospective, single-arm study was designed to assess the efficacy and safety of Glycerol Phenylbutyrate for Chinese pediatric patients with UCD, to provide the additional references and treatment options for Chinese UCD patients, and enhance the clinical management of UCD in China. This study primarily observes patients with UCD who are on long-term treatment with glyceryl phenylbutyrate, the total planned observation period is 5 years.",[507],"Urea Cycle Disorders",[509,510,511,512],"Chinese","Pediatric patients","Urea cycle disorders","Glycerol phenylbutyrate","2026-04-23",{"date":515,"type":33},"2026-04-27",{"date":517,"type":33},"2025-12-09",{"date":519,"type":22},"2031-07",{"name":39,"class":40},5,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":452,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":41},"100631547","efficacy-and-safety-of-firsekibart-in-the-treatment-of-systemic-sclerosis-100631547","NCT07502105","Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis","A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive), male or female.\n2. Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR\u002FEULAR diagnostic criteria.\n3. Disease duration of diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy \\& Medsger (2001), of ≤ 5 years (from the time of first onset of non-Raynaud's phenomenon).\n4. Modified Rodnan skin score (mRSS) ≥10;\n5. Voluntarily signed informed consent form and ability to comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Allergy to the active ingredient of Firsekibart or any of its excipients, or a history of allergy to monoclonal antibodies.\n2. Presence of any rheumatic disease other than SSc.\n3. Moderate to severe lung disease with FVC \\\u003C 60% or DLCO \\\u003C 50% of predicted value.\n4. Use of medications that may interfere with the evaluation of the efficacy and safety of Firsekibart, except for stable use of permitted concomitant therapies that have been maintained for at least 4 weeks prior to screening and are kept at a stable dose throughout the study period.\n5. Use of biological agents or stem cell therapy within 3 months prior to screening or within 5 half-lives of the known drug.\n6. Receipt of live or attenuated vaccines within two months prior to screening.\n7. Severe hepatic impairment, renal impairment, or hematologic abnormalities at screening.\n8. Acute or chronic infection (excluding infection complicated by finger ulceration), active infection, history of malignant tumor, or immunodeficiency disorder.\n9. Women who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period.\n10. Any other conditions that, in the investigator's judgment, render the subject ineligible for this trial.",{"count":530,"type":22},30,[73],"This study is a single-center, single-arm, open-label, exploratory clinical trial. A total of 30 patients with diffuse cutaneous systemic sclerosis (dcSSc) will be enrolled. A historical control cohort will be established to evaluate the efficacy and safety of Firsekibart by comparing with historical data.",[534],"Systemic Scleroderma",[534,536],"SSc","2026-04-15",{"date":539,"type":33},"2026-04-20",{"date":541,"type":22},"2026-05-01",{"date":543,"type":22},"2028-12-01",{"name":39,"class":40},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":552,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":559,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":41},"100619916","early-phase-1-car-t-therapy-targeting-cd19-and-bcma-in-highly-sensitized-kidney-transplant-participants-100619916","NCT07350837","CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants","An Early-Phase Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting CD19 and B Cell Maturation Antigen (BCMA), for Desensitization in Highly Sensitized Participants With End Stage Kidney Disease Awaiting Kidney Transplant","Inclusion Criteria:\n\n* 1\\. Adult men or women aged 18 to 65 years with end-stage kidney disease who are waiting for kidney transplant and require desensitization to enable safe kidney transplant.\n\n  2\\. Cohort 1:\n* A living donor who meets criteria for kidney donation based on national and local center-specific guidelines has been identified\n* Highly sensitized participants with a requirement of positive flow cytometry crossmatch, resulting from at least one DSA detected using Luminex SAB during or before Screening\n* A positive virtual crossmatch, using Luminex SAB (MFI ≥ 2000), obtained within 30 days of Screening and during Screening\n\nCohort 2:\n\n* PRA greater than or equal to 80% which is consistent with highly sensitized based on national criteria\n* At least one anti-HLA antibody that is unacceptable for kidney transplantation 3. High-resolution HLA typing for both the recipient and the donor within 2 years of Screening.\n\n  4\\. The participant is currently eligible for transplantation according to local standards if a graft becomes available upon completion of treatment with the study intervention.\n\n  5\\. Hemoglobin ≥ 8 g\u002FdL. 6. ANC ≥ 800\u002FμL. 7. Absolute lymphocyte count ≥ 2000\u002FμL or CD3 T cell count ≥ 500\u002FμL. 8. Platelet count ≥ 75000\u002FμL. 9. Vaccinations must be up to date in accordance with the national and local center guidance for transplant participants.\n\n  10\\. Positive for EBV capsid IgG. 11. Testing for latent TB infection must be negative within 3 months prior to Screening. Testing should be conducted using either a purified protein derivative or an IFN-γ release assay (ie, QuantiFERON-TB or T-SPOT.TB). Participants with a positive test for latent TB infection must complete appropriate therapy for LTBI.\n\nA participant is considered eligible if he\u002Fshe has a negative test for LTBI within 3 months prior to Screening, or if he\u002Fshe has completed appropriate LTBI therapy prior to transplantation. Treatment for latent TB infection should follow national guidelines.\n\n12\\. Participants must be willing to be hospitalized for at least 2 weeks from the time of AZD0120 infusion and must reside within 2 hours of the hospital for an additional 2 weeks following hospital discharge.\n\n13\\. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\n14\\. Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n15\\. Nonsterilized male participants who are sexually active with female partner of childbearing potential (See Appendix D for details):\n\n(a)Must agree to use one highly effective method of birth control for at least 3 years post AZD0120 infusion.\n\n(b)For participants who receive LDC but not AZD0120, the contraception time lasts from enrollment until 6 months after the last dose of LDC.\n\n(c)Must refrain from fathering a child or donating sperm within 3 years post AZD0120 infusion.\n\n(d)Female partner of a male participant must use one highly effective method of birth control for at least 3 years post AZD0120 infusion.\n\n16\\. Female participants (See Appendix D for details):\n\n1. FOCBP who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control for at least 3 years post AZD0120 infusion. For FOCBP participants who receive LDC but not AZD0120, the contraception time lasts from enrollment until 12 months after the last dose of LDC. Cessation of contraception after this point should be discussed with a responsible physician.\n2. All FOCBP must have a negative serum pregnancy test result 3 days prior to enrollment at Screening.\n3. Must refrain from donating ova within 3 years post AZD0120 infusion.\n\n   Exclusion Criteria:\n   * 1\\. Previous solid organ (except kidney) or bone marrow transplant. 2. Complement 3 glomerulopathy, immune-complex mediated membranoproliferative glomerulonephritis, or focal and segmental glomerulosclerosis as the cause of ESKD in the native kidney.\n\n     3\\. Severe peripheral arterial disease is defined by the presence of resting pain and\u002For non healing skin ulcers.\n\n     4\\. History of recurrent UTI; 2 in 6 months or 3 in one year. 5. Active invasive bacterial, viral or fungal infection. Additionally, any infection requiring hospitalization and IV antibiotics within 4 weeks of Screening or PO antibiotics within 2 weeks.\n\n     6\\. History of HIV regardless of treatment. 7. Evidence of active hepatitis B infection based on positive HBsAg or positive core antibody (anti HBc): participants with positive anti-HBc but negative HBsAg may be enrolled if the HBV DNA test result is negative during the Screening Period.\n\n     8\\. Evidence of active hepatitis C infection - Positive HCV antibody: Participants with positive HCV antibody and negative HCV RNA test during the Screening Period and absence of cirrhosis may be enrolled.\n\n     9\\. Detectable viral load for CMV, EBV, BKV or SARS-CoV-2, as determined by PCR. 10. CMV serology incompatible with donor (eg, a recipient with a CMV negative serology should not receive an organ from a CMV positive donor).\n\n     11\\. History of cirrhosis or severe liver disease, including abnormal liver profile (AST, ALT, or total bilirubin \\> 3 × ULN at Screening, except for participants whose hyperbilirubinemia is attributed to Gilbert's syndrome).\n\n     12\\. History of sickle cell disease or systemic amyloidosis. 13. Any chronic illness requiring uninterrupted anticoagulation or antiplatelet therapy, except for clinical stable and asymptomatic conditions (eg, chronic atrial fibrillation).\n\n     14\\. Active and severe disease requiring prolonged immunosuppressive therapy, except for low dose glucocorticoids (prednisone or prednisone equivalent \\\u003C 10 mg\u002Fday).\n\n     15\\. Receiving ongoing immunosuppressive treatment, including corticosteroids (excepting \\\u003C 10 mg\u002Fd of prednisone or prednisone equivalent), IV immunoglobulin, CYC, mycophenolic acid, or azathioprine, from 90 days prior to Screening.\n\n     16\\. CNI use within 14 days prior to Screening. 17. Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment.\n\n     18\\. Cardiac clearance for transplant \\> 6 months old and\u002For any of the following conditions: NYHA Class III or IV heart failure, unstable angina, LVEF \\\u003C 40%, a history of recent (within 6 months of Screening) myocardial infarction or presence of implantable cardioverter\u002Fdefibrillators and\u002For biventricular pacing.\n\n     19\\. Moderate-severe pulmonary function abnormality, defined as resting oxygen saturation \\\u003C 92% on room air or FEV1, total lung capacity, or DLCO (after correction for hemoglobin) \\\u003C 50% of predicted values within 6 months of Screening.\n\n     20\\. Known life-threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including DMSO.\n\n     21\\. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 years after receiving study intervention.\n\n     22\\. Plans to father a child while enrolled in this study or within 3 years after receiving study intervention.","65 Years",{"count":554,"type":22},12,[456],"The purpose of this study is to assess the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with ESKD awaiting kidney transplant-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)- with or without living donors.",[558],"Highly Sensitized Patients Awaiting Kidney Transplant",[560,561,562,563],"Investigator-Initiated Trial","End-stage kidney disease","Dual directed CD19\u002FBCMA CAR-T desensitization therapy","Kidney Transplantation","2026-04-14",{"date":566,"type":33},"2026-04-16",{"date":568,"type":33},"2026-01-28",{"date":182,"type":22},{"name":39,"class":40},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":578,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":41},"100633482","effects-of-adenoidectomy-on-symptoms-and-ige-levels-in-children-with-ar-100633482","NCT07527260","Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR","Effects of Adenoidectomy With or Without Tonsillectomy on Symptoms and Local IgE Levels in Children With Allergic Rhinitis","Inclusion Criteria:\n\n\\- 3-12 years\n\n1. Children with physician-diagnosed allergic rhinitis and typical symptoms (nasal obstruction, watery rhinorrhea, paroxysmal sneezing);\n2. Co-existing adenoidal and tonsillar hypertrophy meeting surgical indications;\n3. No systemic or topical corticosteroids, leukotriene antagonists, or antihistamines within the past 3 months.\n\nExclusion Criteria:\n\n1. Prior adenoidectomy, tonsillectomy, or radio-frequency ablation;\n2. Nasal polyps, cystic fibrosis, primary ciliary dyskinesia, fungal rhinosinusitis, systemic vasculitis\u002Fgranulomatosis, tumor, or immunodeficiency;\n3. Endoscopic nasal surgery within 6 months or severe asthma precluding surgery;\n4. Upper respiratory infection within 4 weeks;\n5. Serious metabolic, cardiovascular, immune, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any condition judged by the investigator to interfere with outcome assessment or participant safety;\n6. Currently enrolled or within 30 days of participation in another clinical trial.","3 Years","12 Years",{"count":454,"type":22},[73],"This study aims to evaluate the effects of conservative management versus surgical intervention (adenoidectomy alone or adenotonsillectomy) on symptoms and local IgE levels in children with allergic rhinitis (AR) accompanied with adenotonsillar hypertrophy. The primary objectives include the impact of conservative management and surgical interventions on AR symptoms and local IgE levels. The second outcomes include serum IgE levels, inflammatory cell profiles within the nasal mucosa, and postoperative complications.",[584,585,586],"Adenoidectomy","Tonsillectomy","Allergic Rhinitis","2026-04-13",{"date":564,"type":33},{"date":590,"type":22},"2026-04-11",{"date":592,"type":22},"2027-04-01",{"name":39,"class":40},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":607,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":616,"leadSponsor":617,"locationsCount":41},"100634306","phase-2-denosumab-strategy-for-liver-cancer-with-bone-metastases-100634306","NCT07537972","Denosumab Strategy for Liver Cancer With Bone Metastases","Early Denosumab Plus a Uniform PD-1-Based Systemic Therapy Versus Delayed\u002FRescue Bone-Modifying Strategy in Hepatocellular Carcinoma With Bone Metastases: A Single-Center Prospective Randomized Controlled Exploratory Study","Inclusion Criteria:\n\n* Age 18 to 75 years\n* Hepatocellular carcinoma confirmed by imaging and\u002For histology according to current institutional diagnostic standards\n* Bone metastasis confirmed by CT, MRI, bone scintigraphy, PET-CT, or pathology\n* ECOG performance status 0 to 1\n* Child-Pugh class A or stable Child-Pugh B7 judged suitable for systemic treatment\n* At least 1 measurable intrahepatic lesion at baseline and planned initiation of a PD-1 inhibitor-based systemic therapy\n* Estimated life expectancy of at least 3 months\n* Adequate organ function according to protocol-defined laboratory criteria\n* Corrected serum calcium within the normal range, or corrected to protocol-defined range after calcium\u002Fvitamin D supplementation\n* Completed baseline oral\u002Fdental risk assessment and willingness to avoid nonessential invasive dental procedures during the study\n* Written informed consent and willingness to comply with study visits, questionnaires, sample collection, and follow-up\n\nExclusion Criteria:\n\n* Prior treatment with PD-1, PD-L1, CTLA-4, or other immune checkpoint inhibitors\n* Receipt of denosumab or intravenous\u002Foral bisphosphonates for tumor-related bone disease within 6 months before randomization\n* Uncorrected hypocalcemia or severe vitamin D deficiency that cannot be corrected promptly\n* Current or prior osteonecrosis of the jaw, jaw osteomyelitis, or high-risk dental condition requiring near-term extraction, implantation, or other invasive dental procedures that cannot be deferred\n* Active autoimmune disease or need for systemic immunosuppressive treatment, except for low-risk conditions judged acceptable by the investigator\n* Life-threatening bone complication within 4 weeks before randomization that is not stabilized, including unresolved spinal cord compression or clinically significant spinal instability\n* Active infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or other condition judged unsafe for systemic treatment\n* Symptomatic or uncontrolled central nervous system metastases\n* Pregnancy or breastfeeding, or refusal to use effective contraception when applicable\n* Known severe hypersensitivity to denosumab or any study-related treatment component\n* Another active malignancy, poor compliance, or any condition judged by the investigator to make study participation unsuitable",{"count":602,"type":22},50,[25],"This study will evaluate whether starting denosumab early, together with a locked uniform PD-1-based systemic therapy, can reduce skeletal-related events and delay worsening bone pain compared with a delayed\u002Frescue bone-modifying strategy in patients with hepatocellular carcinoma and bone metastases. Participants will be randomly assigned in a 1:1 ratio to receive either early denosumab plus the same PD-1-based systemic therapy or the same systemic therapy with no routine prophylactic bone-modifying agent at baseline and rescue treatment only when predefined triggers occur. The primary outcome is skeletal-related event-free survival. Secondary outcomes include time to first skeletal-related event, pain outcomes, quality of life, intrahepatic antitumor activity at Week 12, progression-free survival, overall survival, and safety.",[439,606],"Bone Metastases",[608,606,609,610,611],"Denosumab","Skeletal-Related Events","Bone Pain","PD-1 Inhibitor","2026-04-12",{"date":614,"type":33},"2026-04-17",{"date":541,"type":22},{"date":211,"type":22},{"name":39,"class":40},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":625,"targetDuration":4,"studyType":23,"phases":626,"briefSummary":627,"conditions":628,"keywords":630,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":641,"locationsCount":41},"100634304","phase-3-local-consolidation-after-sintilimab-plus-lenvatinib-for-metastatic-liver-cancer-100634304","NCT07537946","Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer","Comprehensive Local Consolidative Therapy Versus Continued Sintilimab Plus Lenvatinib Alone After Induction Sintilimab Plus Lenvatinib in Patients With Oligo-Extrahepatic Metastatic Hepatocellular Carcinoma: A Multicenter Prospective Randomized Trial","Inclusion Criteria:\n\n* Age 18 to 75 years\n* Hepatocellular carcinoma confirmed by imaging and\u002For histology according to institutional diagnostic standards\n* Advanced or unresectable disease with extrahepatic metastases meeting protocol-defined oligo-extrahepatic metastatic disease criteria: 1 to 5 extrahepatic metastatic lesions and no more than 2 involved extrahepatic organs\n* At least 1 measurable lesion according to RECIST version 1.1\n* No prior systemic therapy for advanced or metastatic hepatocellular carcinoma\n* ECOG performance status 0 to 1\n* Child-Pugh class A or stable Child-Pugh B7\n* Adequate hematologic, hepatic, renal, and coagulation function according to protocol\n* Baseline center multidisciplinary team assessment indicating potential feasibility for complete consolidative intent if disease control is achieved after induction\n* Written informed consent and willingness to comply with treatment, follow-up, and protocol-required assessments\n\nExclusion Criteria:\n\n* More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs\n* Diffuse peritoneal seeding, leptomeningeal disease, or uncontrolled brain metastases\n* Main portal vein trunk invasion, extensive inferior vena cava or right atrial tumor thrombus, or disease considered unlikely to become fully consolidable after induction\n* Diffuse intrahepatic disease or liver tumor burden considered unlikely to be controllable with protocol-specified local treatment\n* Prior PD-1, PD-L1, CTLA-4, anti-VEGF monoclonal antibody, tyrosine kinase inhibitor, or other systemic antitumor therapy for advanced HCC\n* Active autoimmune disease requiring systemic immunosuppression\n* Active severe infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or uncontrolled hepatitis B without appropriate antiviral therapy\n* Gastrointestinal bleeding within the previous 6 months, or untreated or uncontrolled high-risk gastroesophageal varices\n* Uncontrolled hypertension, recent major thrombotic event, myocardial infarction, unstable angina, or stroke\n* Active interstitial lung disease or noninfectious pneumonitis requiring systemic treatment\n* Severe proteinuria or renal dysfunction considered unsuitable for lenvatinib treatment\n* Pregnancy or breastfeeding\n* Any condition that, in the investigator's judgment, would make participation unsafe or compromise protocol compliance",{"count":50,"type":22},[224],"This study evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. All enrolled participants receive induction treatment with sintilimab plus lenvatinib for 4 cycles. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for complete consolidation are randomized in a 1:1 ratio to receive either comprehensive local consolidative therapy followed by continued systemic therapy or continued systemic therapy alone. The primary outcome is overall survival.",[439,629],"Metastases",[631,632,203,633,634,635,636],"Oligometastatic","Hepatocellular Carcinoma","Lenvatinib","Comprehensive Local Consolidative Therapy","Surgery","Ablation",{"date":614,"type":33},{"date":206,"type":22},{"date":640,"type":22},"2031-07-30",{"name":39,"class":40},""]