[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking Union Medical College\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":370},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,45,71,93,114,142,166,189,213,234,256,274,298,320,342],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100643168","tooth-and-bone-borne-cuttingrepositioning-guide-and-patient-specific-implantpsi-100643168",false,"NCT07634276","Tooth and Bone-borne Cutting\u002FRepositioning Guide and Patient-specific Implant(PSI)","A Prospective, Randomized, Controlled, Single-blind Study on the Hybrid Tooth and Bone-supported Cutting and Repositioning Guides Versus Computer-aided Design\u002FComputer-aided Manufactured Splints in \"Surgery-first\" Orthognathic Surgery","PSI","Inclusion Criteria:\n\n1. Age ranged from 18 to 40 years old.\n2. Patients were diagnosed with dentofacial deformity and received treatment at the Plastic Surgery Hospital, Chinese Academy of Medical Sciences. The diagnosis was confirmed via comprehensive evaluation by two senior attending plastic surgeons.\n3. Patients were scheduled for bimaxillary orthognathic surgery, with optional adjunctive procedures including maxillary and mandibular subapical osteotomy and genioplasty.\n4. Patients were indicated for the surgery-first approach based on joint assessment by craniomaxillofacial surgeons and orthodontists. Orthodontists confirmed that satisfactory occlusal relationships could be achieved through postoperative orthodontic treatment. Preoperative dental conditions met the following requirements: no or mild anterior dental crowding, flat or shallow Spee's curve, slight incisor inclination, harmonious maxillary and mandibular dental arches, and at least three stable occlusal contacts under transitional occlusion.\n5. Patients agreed to complete follow-up examinations and provided signed informed consent.\n\nExclusion Criteria:\n\n1. Patients who refused to participate in the present study.\n2. Presence of comorbidities that may increase surgical risks or impair surgical outcomes, as assessed by two senior plastic surgeons, including but not limited to hypertension, diabetes, immune thrombocytopenic purpura, and hemoglobin (Hb) level ≤ 100 g\u002FL.\n3. Presence of body dysmorphic disorder, a history of psychiatric disorders, or excessively demanding patients with unrealistic treatment expectations.\n4. Presence of facial skeletal tumors.\n5. Patients who required revision surgery after previous orthognathic procedures.\n6. Cases judged unable to achieve stable occlusal relationships through postoperative orthodontic treatment following joint evaluation by craniomaxillofacial surgeons and orthodontists, including patients with severe dental crowding, maxillomandibular arch width discrepancy, temporomandibular joint disorders, or periodontal diseases.",true,"ALL","18 Years","40 Years",{"count":22,"type":23},50,"ESTIMATED","INTERVENTIONAL",[26],"NA","Dentofacial deformity refers to a group of disorders characterized by malocclusion and facial asymmetry resulting from developmental abnormalities of the maxilla and mandible, which cause morphological and positional anomalies of the jaws. Compared with the traditional orthodontics-orthognathic surgery-orthodontics treatment protocol, the surgery-first approach has witnessed a continuous expansion of its clinical application scope. Nevertheless, academic controversies persist regarding its indication boundaries, postoperative jaw stability, and adaptive changes of the temporomandibular joint.\n\nIn orthognathic surgery, computer-aided design\u002Fcomputer-aided manufacturing (CAD\u002FCAM) surgical guides indirectly determine the three-dimensional spatial positions of the maxilla and mandible through occlusal relationships. The tooth-bone dual-supported osteotomy and positioning guide combined with pre-bent patient-specific implants (PSIs) forms a novel surgical guide system that enables independent and direct positioning of the maxilla. Theoretically, this system can eliminate errors derived from mandibular positional instability and thereby improve surgical accuracy. However, comparative studies investigating the clinical application of these two types of guides in surgery-first orthognathic surgery are still lacking.\n\nThis prospective, randomized, controlled, single-blind clinical study aimed to explore the clinical value of PSIs and conventional CAD\u002FCAM guides in surgery-first orthognathic surgery, with primary outcomes focusing on surgical accuracy, postoperative jaw stability, and temporomandibular joint alterations. The findings will provide evidence-based medical support for the expanded application of this novel technique in precision orthognathic surgery.",[29,30,31,32],"CAD\u002FCAM","Patient Specific Implant","Orthognathic Surgery","Surgery-first","NOT_YET_RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":36,"type":23},{"date":40,"type":23},"2028-12-31",{"name":42,"class":43},"Peking Union Medical College","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100527249","phase-2-precision-treatment-of-recurrentmetastatic-salivary-gland-carcinoma-guided-by-molecular-typing-100527249","NCT06145308","Precision Treatment of Recurrent\u002FMetastatic Salivary Gland Carcinoma Guided by Molecular Typing","Cancer Hospital, Chinese Academy of Medical Sciences\u002FNational Cancer Center of China","Inclusion Criteria:\n\n* Patients with histopathologic diagnosis of salivary gland carcinoma\n\n  * The tumor tissues were subjected to HER2\u002FNTRK\u002FAR\u002FTROP-2 immunohistochemical staining.\n\n    * ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;\n\n      * Age 18 or older - no upper limit;\n\n        * Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a negative pregnancy test within 7 days before the first medication, and agree to receive the necessary contraceptive measures;\n\n          ⑧The patient must have adequate liver, kidney, bone marrow, heart and lung and other organ functions:\n\n          ⑨Understanding and voluntarily signing informed consent prior to performing any research-related evaluation\u002Foperation;\n\n          ⑩Ability to comply with research visit schedules and other programmatic requirements.\n\nExclusion Criteria:\n\n* Known hypersensitivity or delayed anaphylaxis to any agents in this trial;\n\n  * Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;\n\n    * Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;\n\n      * To study the occurrence of arterial\u002Fvenous thrombosis events within 6 months before medication;\n\n        * Major cardiovascular diseases;\n\n          * Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;\n\n            * Is suffering from an active infection that requires systemic treatment;\n\n              * History of active tuberculosis; ⑨ Positive human immunodeficiency virus (HIV) test result; ⑩ Patients with chronic hepatitis B or active hepatitis C. ⑪Conditions that the investigator believes will affect the safety or compliance of the drug therapy in this study ⑫Female\u002Fmale who is pregnant or breastfeeding or who intends to give birth;","100 Years",{"count":54,"type":23},39,[56],"PHASE2","Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.",[59,60],"Salivary Gland Carcinoma","Precision Therapy","RECRUITING","2026-03-27",{"date":64,"type":37},"2026-04-02",{"date":66,"type":37},"2023-08-15",{"date":68,"type":23},"2028-07-10",{"name":42,"class":43},2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":18,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":24,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100619466","effect-of-indoor-air-quality-improvement-on-health-in-patients-with-interstitial-lung-disease-100619466","NCT07344987","Effect of Indoor Air Quality Improvement on Health in Patients With Interstitial Lung Disease","A Randomized Crossover Trial of Indoor Air Quality Improvement on Health in Patients With Interstitial Lung Disease","Inclusion Criteria:\n\n* Patients diagnosed with interstitial lung disease (ILD).\n* Stable disease status, defined as no hospitalization due to acute exacerbation within the past month.\n\nExclusion Criteria:\n\n* Patients with complications of severe organ failure (including heart, liver, or kidney failure), malignant tumors, or mental disorders.\n* A history of respiratory tract infection within the past two weeks.","19 Years",{"count":80,"type":23},100,[26],"Air pollution threatens the respiratory health of patients with interstitial lung disease (ILD). High-efficiency air purifiers, featuring easy operation and excellent particulate matter removal efficiency, have been shown in previous studies to potentially delay lung function deterioration and reduce acute exacerbation risk in respiratory disease patients. This randomized crossover study employs air purifiers to filter indoor gaseous pollutants, allergens, and other contaminants, aiming to alleviate respiratory irritation, improve daily life comfort, and enhance overall health status in ILD patients.",[84],"ILD","2026-01-07",{"date":87,"type":37},"2026-01-15",{"date":89,"type":23},"2026-03",{"date":91,"type":23},"2027-06",{"name":42,"class":43},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":24,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":70},"100509744","nutritional-support-on-outcomes-and-cost-effectiveness-for-patients-at-risk-100509744","NCT05917418","Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk","Impact of Nutritional Support on Outcome,Cost\u002FEffectiveness for Patient at Risk","Inclusion Criteria:\n\n* patients be in hospital overnight\n* diagnoses according to the protocol of cohort study for cost effectiveness\n\nExclusion Criteria:\n\n* patients admitting from emergency department\n* patients who undergone operation before second morning of hospitalization\n* patients who dose not give Informed Consents","90 Years",{"count":102,"type":23},400,[26],"The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.",[106],"Malnutrition",{"date":108,"type":37},"2026-01-09",{"date":110,"type":23},"2026-12-01",{"date":112,"type":23},"2040-01-30",{"name":42,"class":43},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":5},"100079403","nutrition-support-on-outcomes-and-cost-effectiveness-for-patients-at-risk-100079403","NCT00289380","Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk","1. Prevalence of Nutritional Risk-undernutrition-support in China-Euro-USA. 2. Impact of Nutrition Support on Outcome for Patient at Risk. 3. Impact of Nutrition Support on Outcome,Cost\u002FEffectiveness for Patient at Risk.","80 Years",{"count":122,"type":23},2000,"OBSERVATIONAL","1. The aim of this large scale study to survey the prevalence of nutritional risk and malnutrition in China,Europe and USA.\n2. The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness\n\nAlready get the approval by Ethics Committee of Peking Union medical college and Johns Hopkins Hospital.",[106,126],"Nutritional Risk",[128,106,129,130,131,132,133,134,135],"Nutritional Risk Screening(NRS)","Overweight","Obesity","Clinical nutritional support","Clinical outcome","Cost effectiveness","Complication","Infective complications",{"date":108,"type":37},{"date":138,"type":4},"2005-01",{"date":140,"type":23},"2040-01",{"name":42,"class":43},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":24,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":44},"100613014","phase-4-comparison-of-the-clinical-efficacy-and-safety-of-topical-and-subcutaneous-injection-of-secukinumab-in-hs-100613014","NCT07261072","Comparison of the Clinical Efficacy and Safety of Topical and Subcutaneous Injection of Secukinumab in HS","Comparison of the Efficacy and Safety of Topical and Subcutaneous Injection of Secukinumab in HS: A Prospective Exploratory Trial","Inclusion Criteria:\n\n1. Meet international diagnostic criteria for hidradenitis suppurativa\n2. Aged ≥ 18 years\n3. Disease duration ≥ 6 months and resistance to conventional therapy (no significant improvement for ≥ 3 months)\n4. Lesions were confined to a single anatomical area\n5. Voluntarily signed the informed consent form and was able to cooperate in all visits and examinations.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any component of secukinumab injection\n2. With severe vital organ failure\n3. With active infection or malignancy (malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin and cured)\n4. Treatment with biologics, immunosuppressants, or systemic corticosteroids within the last 3 months\n5. Pregnant, nursing, or planning conception during the study\n6. Mental disorders or cognitive impairment that precludes understanding of study procedures\n7. Participating in another clinical study and are at risk of an interaction between the study drugs\n8. Other conditions assessed by the investigators as inappropriate for participation in the study",{"count":150,"type":23},30,[152],"PHASE4","Secukinumab is currently approved in Europe, US and China for the treatment of moderate to severe HS as a biologic agent targeting IL-17A.Two phase III clinical trials (SUNSHINE and SUNRISE) showed that 300 mg s.c. every 2 weeks resulted in 42% to 45% of patients achieving a clinical response (HiSCR) to HS, and the efficacy was sustained through 52 weeks.However, we found in clinical practice that some HS patients present with localized lesions (small areas of involvement, affecting only 1-2 anatomic areas) that are resistant to conventional therapy, and have not yet fulfilled surgical indications, and the need for systemic biologic therapy is controversial.Such patients often experience inadequate response or slow onset of action when they receive secukinumab by routine subcutaneous injection - possibly related to inadequate drug concentration in the focal lesional area and limited local anti-inflammatory effects after systemic administration.In addition, side effects of conventional subcutaneous injection system are greater, and the application is limited in some patients, so it is necessary to explore more appropriate and safer drug delivery method for localized skin lesions.Localized HS, local injection of lesions may enhance anti-inflammatory effects while reducing systemic exposure by increasing drug concentrations at the lesion site.Therefore, exploring novel modes of administration of secukinumab has practical clinical implications based on clinical practice needs and the context of the previous literature.In summary, by exploring the efficacy and safety of local skin injection of secukinumab, this study may provide a new strategy for the treatment of limited HS with sufficient scientific rationale and significant potential benefits and manageable risks.",[155,156,157],"Hidradenitis Suppurativa (HS)","Hidradenitis Suppurativa (Acne Inversa)","Secukinumab","2025-12-02",{"date":160,"type":37},"2025-12-03",{"date":162,"type":23},"2025-12-01",{"date":164,"type":23},"2026-12-31",{"name":42,"class":43},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":24,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":44},"100611949","real-world-first-line-sugemalimab-chemotherapy-in-advanced-nsclc-100611949","NCT07247227","Real-world First-line Sugemalimab-Chemotherapy in Advanced NSCLC","Sugemalimab Plus Platinum-based Chemotherapy as First-line Therapy for Patients With Locally Advanced and Metastatic Non-small Cell Lung Cancer (NSCLC) in a Real-world Setting: a Single-arm, Multi-center Study","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients voluntarily join the study and sign an informed consent form for the study.\n3. ECOG PS score 0-3 (patients with PS score 2-3 would be enrolled if due to the tumor disease and anticipated to be improved at investigators' decision).\n4. Histologically documented, stage III, IV non-Small Cell Lung Cancer (according to version 8th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated systematically(excluding local therapy for local lesions or symptomatic relief, palliative radiotherapy, intervention, intrathecal injection, nerve block, etc.).\n5. Patients with stage III NSCLC who are not suitable for surgery at a multidisciplinary discussion or investigators' assessment.\n6. Patients with at least one measurable target lesion by CT scan\u002FMRI (RECISTv1.1).\n7. Patients with active brain metastases and liver metastases could be enrolled (Concurrent radiotherapy, intervention, dehydration, and other local treatment are permitted).\n8. Interstitial pneumonia, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms of grade 2, can be included after symptomatic treatment until recovery to grade 0-1.\n9. Fertile men and women of childbearing age must agree to take effective contraceptive measures from signing the main informed consent until 180 days after the last dose of the study drug. Women of childbearing potential include premenopausal women and women within 2 years of menopause. Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of study drug.\n\nExclusion Criteria:\n\n1. All patients carry activating mutations of EGFR, ALK, ROS1, and RET. (No more mutation test needed).\n2. Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).\n3. Histopathologically or cytopathologically confirmed non-NSCLC.\n4. Any prior treatment of antibody\u002Fdrug that targets T-cell coregulatory proteins (not limited to CTLA-4 inhibitors or other agents targeting T cells).\n5. Any tumor history within the past 5 years prior to the start of treatment in this study (except cured cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors with surgical resection alone and at least 5 consecutive years of disease-free survival).\n6. Patients with active, unstable systemic disease, active infection, uncontrolled hypertension, heart failure (NYHA class \\>= II), unstable angina pectoris, acute coronary syndrome, severe arrhythmia, severe liver, kidney, or metabolic diseases, HIV infection.\n7. Pregnant or lactating women.\n8. Systemic anti-tumor therapy planned within 4 weeks before first-line treatment or during medication after enrollment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (with the exception of thymosin, lentinan, and other immunomodulator therapy).\n9. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before 1st line therapy.\n10. Participation in other anti-tumor drug clinical trials within 4 weeks before first-line therapy.\n11. Active, known, or suspected autoimmune diseases. Vitiligo and Type I diabetes mellitus with no systemic treatment are allowed. Residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy is allowed.\n12. With known mental illness, alcoholism, drug abuse, or other factors which may cause termination of this study, affect the safety of subjects, or collection of data and samples.",{"count":174,"type":23},150,[26],"This single-arm, multi-center study is to evaluate Sugemalimab plus platinum-based chemotherapy as first-line therapy for patients with locally advanced and metastatic NSCLC in a real-world setting.",[178],"NSCLC",[180,178],"sugemalimab","2025-11-22",{"date":183,"type":37},"2025-11-25",{"date":185,"type":37},"2023-10-10",{"date":187,"type":23},"2027-05",{"name":42,"class":43},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":18,"minAge":196,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":24,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100518143","effectiveness-and-cost-effectiveness-of-digital-psychological-intervention-emoease-in-chinese-copd-patients-100518143","NCT06026709","Effectiveness and Cost-effectiveness of Digital Psychological Intervention (EmoEase) in Chinese COPD Patients","Effectiveness and Cost-effectiveness of an Integrated Digital Psychological Intervention (EmoEase) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 35 years or older;\n2. Post-bronchodilator FEV1\u002FFVC ≤70% or confirmed COPD patients;\n3. Literate and able to type;\n4. Have a smartphone;\n5. Be proficient in using the WeChat applet;\n6. Willingness to self-help iCBT sessions for 8 weeks, 10-20 minutes of practice per session, roughly 1 hour per week, time and place flexible;\n7. Receive three follow-up visits within four months (2 offline, 1 online) and complete a physical exam and online questionnaire; and\n8. Willingness to provide the hospital with their usual cell phone number.\n\nExclusion Criteria:\n\n1. Patients with a physician diagnosis of asthma or asthma-COPD overlap syndrome;\n2. Patients hospitalized for COPD within the previous one year;\n3. Having severe cognitive dysfunction and being unable to communicate;\n4. Severely ill with less than 12-month life expectancy.","35 Years",{"count":198,"type":23},1200,[26],"Background Mental health issues are common and often overlooked in COPD patients. Digital psychological interventions might help, but their effectiveness in Chinese COPD patients hasn't been studied. This study aims to develop and evaluate EmoEase, a digital psychological intervention, for its effectiveness and cost-effectiveness in improving mental wellbeing in Chinese COPD patients.\n\nMethods This multicenter, two-arm, randomized controlled trial (RCT) will enroll at least 420 COPD patients over 35 years old. Participants will receive either usual care (control group) or usual care plus EmoEase (intervention group). Assessments will occur at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3). Participants will complete questionnaires and undergo physical measurements. The primary outcome will be mental wellbeing measured by the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes will assess mental and physical health, COPD symptoms, health risk behaviors, socioeconomic factors, and healthcare use and costs. Analyses will use an intention-to-treat approach.\n\nDiscussion This is the first RCT to evaluate EmoEase for COPD patients. If effective and cost-effective, EmoEase could be scaled up to provide mental health support to COPD patients in China.",[202,203,204],"Chronic Obstructive Pulmonary Disease","Depression","Anxiety","2025-08-08",{"date":207,"type":37},"2025-08-13",{"date":209,"type":23},"2025-10-01",{"date":211,"type":23},"2026-01-30",{"name":42,"class":43},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":44},"100601382","secukinumab-treatment-for-moderate-to-severe-hidradenitis-suppurativa-100601382","NCT07109765","Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa","Real-World Evaluation of Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa","Inclusion Criteria:\n\n* age ≥18 years\n* diagnosis of moderate-to-severe HS with Hurley stage II or III\n* Disease duration of ≥6 months, presence of at least one draining tunnel or two inflammatory nodules\n* inadequate response to prior treatments, such as antibiotics, isotretinoin, or TNF inhibitors\n\nExclusion Criteria:\n\n* active infections (e.g., viral hepatitis, active tuberculosis)\n* use of other biologics or systemic immunosuppressants within the past three months\n* severe organ dysfunction (e.g., hepatic or renal failure)\n* any other conditions that might affect study results",{"count":22,"type":23},"This single-center, prospective, observational study aimed to evaluate the efficacy and safety of Secukinumab in treating moderate-to-severe hidradenitis suppurativa (HS). The study was conducted from June 1, 2025, to June 1, 2026, and all participants were treated at the Department of Dermatology, Peking Union Medical College Hospital. The study was approved by the Clinical and Research Ethics Committee of the Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (Ethics Approval No. I-24PJ1844). All procedures involving human participants adhered to the Declaration of Helsinki. Written informed consent form was signed and obtained from the participant.",[155],[224,157,225],"Hidradenitis Suppurativa","ultrasound","2025-07-31",{"date":228,"type":37},"2025-08-07",{"date":230,"type":37},"2025-06-01",{"date":232,"type":23},"2026-06-01",{"name":42,"class":43},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":44},"100574083","effect-of-hypophosphatemia-on-neuro-excursion-efficiency-during-mechanical-ventilator-weaning-100574083","NCT06754670","Effect of Hypophosphatemia on Neuro-excursion Efficiency During Mechanical Ventilator Weaning","Hypophosphatemia in Wean","Inclusion criteria:\n\nage ≥18 years old; Acute respiratory failure, tracheal intubation patients; Invasive ventilator use time ≥48 hours; Clinically determined remission of primary disease, has switched to auxiliary ventilation mode and plans to go offline in the near future.\n\nExclusion criteria:\n\npatients with severe neuromuscular disease; Patients with central system diseases; Patients using muscle relaxants for more than 48 hours; Patients who have been or are about to be discontinued from life support; Patients with contraindications for gastric tube insertion after esophagogastric fundus varices, digestive tract perforation, and upper digestive tract surgery; Pregnant patients; Ultrasonic window is poor.",{"count":242,"type":23},70,"Hypophosphatemia is a common phenomenon in the ICU, and several retrospective studies have shown that hypophosphatemia is associated with prolonged mechanical ventilation in ICU patients. However, the specific mechanism and causal relationship are not clear. Previous studies have shown that phosphate infusion improves the contraction of the diaphragm induced by exogenous electrical stimulation, but the effect of hypophosphatemia and phosphate supplementation on the pathophysiology in decannulated patients on mechanical ventilation has not been confirmed. The study group hypothesized that hypophosphatemia affects neural conduction function and muscle contraction by affecting ATP synthesis. Correcting hypophosphatemia may improve respiratory muscle strength and potentially improve diaphragmatic neural conduction, ultimately improving the patient's neuromuscular conversion efficiency and facilitating discharge.\n\n1. The attending physician evaluates the patient's ventilator condition daily and meets the disconnection criteria (spontaneous breathing, RSBI \\\u003C 105 (min\\*ml)-1, stable hemodynamics: norepinephrine or epinephrine ≤ 0.1μg\u002Fkg\u002Fmin, PEEP ≤ 8cmH2O, FiO2 ≤ 50%, no increase in ventilator support conditions in the past 24 hours, PS 10cmH2O, MAAS score 2-4, pH ≥ 7.30, discontinuation of all sedative medications). After signing an informed consent form, a diaphragm electromyography (EEG) catheter is placed. (The diaphragm EEG catheter is a gastric tube with diaphragm electromyography monitoring function, with the same placement process and risks as a regular gastric tube. There is a small probability of complications such as nasal mucosal damage.)\n2. Start CPAP disconnection: Adjust the ventilator PS 10 → 0 cmH2O, and keep the other conditions unchanged. Collect ventilator parameters, diaphragm electromyography (EAdi) parameters, and diaphragm ultrasound parameters at 0, 1, 3, 5, 10, 20, and 30 minutes after the trial begins, and collect the maximum EAdi and diaphragm ultrasound during quiet state.\n3. Simultaneously monitor blood inorganic phosphorus, and divide the patients into two groups: the low phosphorus group (\\\u003C0.8mmol\u002FL) and the control group (0.8-1.4 mmol\u002FL). Low phosphorus patients receive intravenous phosphate supplementation according to the clinical phosphate supplementation protocol at our center \\[1-5\\]: patients with blood phosphorus \\\u003C 0.4mmol\u002FL receive 40mmol of glycerol phosphate sodium intravenously via infusion or injection over 4-6 hours; patients with blood phosphorus 0.4-0.8mmol\u002FL receive 30mmol of glycerol phosphate sodium intravenously via infusion or injection; Normal phosphorus patients do not require any special treatment.\n4. 24h after the first CPAP offline, patients in both groups repeated the CPAP offline process, collected related parameters, and measured blood inorganic phosphorus.",[245,246,247],"Mechanical Ventilation","Weaning Failure","Hypophosphatemia","2025-05-27",{"date":250,"type":37},"2025-05-31",{"date":252,"type":37},"2024-10-01",{"date":254,"type":23},"2025-08-01",{"name":42,"class":43},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":120,"enrollmentInfo":263,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":44},"100587269","efficacy-and-safety-of-secukinumab-in-conjunction-with-surgery-in-moderate-to-severe-hidradenitis-suppurativa-100587269","NCT06926192","Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa","Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: An Open-label Cohort Study in Real Clinical Practice","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS\n2. The diagnosis of HS was confirmed by histopathological examination in the Department of Pathology of our hospital\n3. Patients with HS who received secukinumab combined with surgery in the Department of Dermatologic Surgery of our hospital\n4. Patients with complete clinical data followed up for at least 1 year\n\nExclusion Criteria:\n\n1. Patients lost to follow-up\n2. Patients with less than one year of follow-up\n3. Patients who received additional adjuvant therapy during the follow-up period",{"count":80,"type":23},"This study aims to retrospectively analyze the efficacy and safety of secukinumab combined with surgery in treating moderate to severe HS in real-world clinical practice, providing clinical practioners with real-world evidence in HS treatment.",[155,156,157],"2025-04-11",{"date":268,"type":37},"2025-04-16",{"date":270,"type":37},"2020-01-01",{"date":272,"type":23},"2025-06-21",{"name":42,"class":43},{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":24,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":4},"100578340","stroke-homecare-and-recurrence-prevention-100578340","NCT06810024","Stroke Homecare and Recurrence Prevention","SHARP","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Diagnosed with ischemic or hemorrhagic stroke within the past month\n* Clinically stable, having completed acute phase treatment, and about to be discharged in a normal condition\n* Physically able to receive home-based health care services\n* Residing in a community where home-based health care is available\n* Able to provide informed consent or have a legally authorized representative provide consent\n\nExclusion Criteria:\n\n* Receiving more than one month of post-discharge care at a stroke rehabilitation center or community rehabilitation center\n* Severe comorbidities (e.g., cancer, respiratory failure, severe infections) with a life expectancy of less than 6 months\n* Severe cognitive impairment or mental illness affecting adherence to the intervention\n* Currently participating in another clinical trial",{"count":282,"type":23},1614,[26],"Background and Significance:\n\nStroke is the leading cause of death in China, placing a heavy burden on patients, families, and society. Despite advancements in acute stroke treatment, the recurrence rate remains high, and secondary prevention faces significant challenges. Current standard care does not fully address the diverse needs of stroke patients. Home-based health care (HBHC) offers a promising new intervention, providing continuous medical support, personalized lifestyle changes, and improved medication adherence, potentially reducing the risk of stroke recurrence.\n\nStudy Objectives and Hypotheses:\n\nThe study seeks to assess the impact of HBHC on reducing stroke recurrence, improving quality of life, enhancing physical function, addressing psychological health issues, and increasing medication adherence. Additionally, the study will explore the cost-effectiveness of HBHC in reducing medical resource utilization and preventing cardiovascular events. It is hypothesized that HBHC will effectively reduce stroke recurrence and improve overall health outcomes.\n\nStudy Design This study is a multicenter, randomized controlled trial designed to assess the effectiveness and cost-effectiveness of a home-based health care (HBHC) model in preventing recurrent strokes. A total of 1,614 stroke patients will be recruited from multiple regions in China and randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a comprehensive 12-month HBHC program that includes managing stroke recurrence risk factors, functional rehabilitation, daily living skills recovery, psychological health interventions, nutritional and lifestyle counseling, risk prevention, and caregiver empowerment. In contrast, the control group will receive standard post-stroke care and follow-up according to local guidelines. Both groups will undergo follow-up assessments at 6 and 12 months to evaluate stroke recurrence, quality of life, physical function, and psychological health. The study will span 2 years, with the primary outcome being the stroke recurrence rate within 12 months. Secondary outcomes include improvements in quality of life, physical function recovery, psychological health, medication adherence, cardiovascular events, and medical resource utilization. A process evaluation will also be conducted to assess the feasibility, adaptability, and implementation challenges of the HBHC model across different regions and patient populations.\n\nValue and impact:\n\nThe findings will offer valuable insights into the feasibility and adaptability of HBHC across different regions and patient populations, contributing to the development of evidence-based strategies for improving long-term stroke management. Ultimately, this research will inform policy decisions, enhance clinical practice, and support the broader adoption of HBHC interventions to mitigate the burden of stroke and improve patient outcomes.",[286],"Stroke",[288,289],"stroke","home-based care","2025-02-04",{"date":292,"type":37},"2025-02-05",{"date":294,"type":23},"2025-02-27",{"date":296,"type":23},"2026-04-26",{"name":42,"class":43},{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":17,"sex":18,"minAge":196,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":24,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":319,"locationsCount":4},"100526940","china-hypertension-and-diabetes-care-cascade-study-100526940","NCT06141278","China Hypertension and Diabetes Care Cascade Study","CHICCs","Inclusion Criteria:\n\n* Permanent residents of the surveyed village (residing for more than six months each year).\n* Age between 35 and 74 years old.\n\nExclusion Criteria:\n\n* Individuals with severe mental disorders or communication barriers.\n* Individuals planning to move out of the village within the next year.\n* Expected life expectancy of less than one year.\n* Pregnant or lactating individuals.\n* Individuals who are currently away (i.e. hospitalized, or residing elsewhere) so that cannot participate in the survey.","74 Years",{"count":307,"type":23},14400,[26],"This implementation study aims to identify priorities and formulate strategies to overcome health service delivery bottlenecks associated with hypertension and diabetes in rural China. Leveraging implementation frameworks, the study seeks to unravel the complexities embedded within the care cascade, paving the way for targeted interventions. Addressing the nuanced dynamics of the care cascade, this research will provide indispensable insights for optimising healthcare delivery in resource-limited settings, ultimately informing global perspectives on chronic disease management.\n\nThe overall aim of this study is to enhance the control of hypertension and diabetes in rural China through a systematic assessment and improvement of the care cascade, specifically:\n\n1. To describe the cascade gap and identify barriers and facilitators at each cascade stage.\n2. To develop practical interventions through stakeholder co-design.\n3. To assess the effectiveness of developed interventions and evaluate implementation strategies.",[311,312],"Hypertension","Diabetes","2023-11-15",{"date":315,"type":37},"2023-11-21",{"date":317,"type":23},"2024-01-01",{"date":164,"type":23},{"name":42,"class":43},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":24,"phases":329,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":4},"100508281","phase-1-vedicitumomab-alone-or-in-combination-for-the-treatment-of-locally-advanced-or-metastatic-sdc-100508281","NCT05898373","Vedicitumomab Alone or in Combination for the Treatment of Locally Advanced or Metastatic SDC","Phase II, Multi-arm, Open Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent Vedicitumomab Alone or in Combination for the Treatment of Locally Advanced or Metastatic Salivary Gland Ductal Carcinoma","Inclusion Criteria:\n\n(1) Patients with advanced metastatic salivary gland ductal carcinoma diagnosed histopathologically at the primary site or metastasis; (2) Original paraffin-embedded tumor tissue stained for HER2 at diagnosis, either HER2 1+\u002FHER2 2+\u002FHER2 3+, previous test results (confirmed by the investigator) or test results from the study center are acceptable; (3) ECOG physical status 0 or 1 within 3 days prior to the first dose of study treatment; (4) 18 years of age or older - upper limit; (5) Life expectancy greater than 3 months according to RECIST 1.1 criteria; (6) At least one measurable lesion; and (7) a score of 0 or 1 for ECOG physical status within 3 days prior to the first dose of study treatment. status 0 or 1 within 3 days prior to the first dose of study treatment; ④ 18 years of age or older - no upper limit; ⑤ life expectancy greater than 3 months; ⑥ at least one measurable lesion according to RECIST 1.1 criteria;(7) Female subjects should be surgically sterilized, post-menopausal, or agree to use at least one medically approved contraceptive (e.g., IUD, pill, or condom) during and for 6 months after the study treatment period, and must have a negative blood pregnancy test within 7 days prior to study entry and must be non-lactating. Male subjects should agree to use at least one medically approved contraceptive measure during the study treatment period and for 6 months after the end of the study treatment period; ⑧ Patients must have adequate liver, kidney, bone marrow, heart and lung organ function: bone marrow function: (1) hemoglobin ≥ 90 g\u002FL; (2) absolute neutrophil count ≥ 1.5 × 109\u002FL; (3) platelets ≥ 100 × 109\u002FL Liver function (based on the normal value of the clinical trial center): (1) without liver metastases, serum total bilirubin ≤ 1.5 times ULN; with liver metastases, serum total bilirubin ≤ 3 times ULN (2) without liver metastases, ALT and AST are ≤ 3 times ULN, with liver metastases, ALT and AST are ≤ 5 times ULN Kidney function (based on the normal value of the clinical trial center): (1) blood creatinine ≤ 1.5 times ULN, or 1.5 times ULN, or Cockcroft-Gault formula calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin, or measured 24-hour urine CrCl ≥ 60 mL\u002Fmin; cardiac function: (1) New York Heart Association (NYHA) classification \\\u003C3 (2) left ventricular ejection fraction ≥ 50%\n\nExclusion Criteria:\n\n(i) treatment with an investigational drug or other antibody-coupled drug targeting HER2 at the start of the study drug; (ii) major surgery within 4 weeks prior to the start of the study drug and incomplete recovery; (iii) live vaccination within 4 weeks prior to the start of the study drug or any vaccine planned during the study period (except novel coronavirus vaccine);(iv) an arterial\u002Fvenous thrombotic event such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, or pulmonary embolism within 6 months prior to study drug administration; (v) major cardiovascular disease (NYHA class 3 or 4 heart failure, second degree or greater heart block, myocardial infarction within the past 12 months, unstable arrhythmia or unstable angina, cerebral infarction within 6 months, etc.); (vi) ongoing unstable controlled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc;(7) Active infection requiring systemic therapy; (8) History of active tuberculosis; (9) Positive human immunodeficiency virus (HIV) test result; (10) Positive hepatitis B surface antigen (HBsAg) with an HBV DNA copy number greater than the upper limit of normal values in the laboratory department of the study center; or (11) Positive hepatitis C virus (HCV) antibody with an HCV RNA copy number greater than the upper limit of normal values in the laboratory department of the study center; or (12) Positive hepatitis C virus (HCV) antibody with an HCV RNA copy number greater than the upper limit of normal values in the laboratory department of the study center. ⑪Conditions that, in the opinion of the investigator, may affect the safety or compliance with the study drug therapy, including but not limited to large pleural\u002Fperitoneal\u002Fpericardial effusions, uncorrectable pleural\u002Fperitoneal\u002Fpericardial effusions, psychiatric disorders, etc. ⑪Known hypersensitivity or delayed hypersensitivity to certain components of the recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent vedicizumab (Edisil, RC48) for injection or similar drugs Hypersensitivity or delayed hypersensitivity reactions; ⑬Women who are pregnant or breastfeeding or women\u002Fmen who are planning to have children",{"count":328,"type":23},120,[330,56],"PHASE1","(1) To apply Bayesian statistics to screen for the most effective treatment regimen containing recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent vedicitumomab (Edisil, RC48) for locally advanced or metastatic salivary gland ductal carcinoma expressing HER2 in the near future. (2) To explore biomarkers relevant to the efficacy of recombinant humanized anti-HER2 monoclonal antibody-MMAE-coupled vedicitumomab (Edisil, RC48) in the treatment of HER2-expressing locally advanced or metastatic salivary gland ductal carcinoma.",[333],"Salivary Gland Cancer","2023-06-09",{"date":336,"type":37},"2023-06-12",{"date":338,"type":23},"2023-06-07",{"date":340,"type":23},"2026-06-06",{"name":42,"class":43},{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":349,"minAge":19,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":24,"phases":353,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":44},"100419043","phase-3-inetetamab-plus-rapamycin-and-chemotherapy-for-her2-metastatic-breast-cancer-with-abnormal-activation-of-pam-pathway-100419043","NCT04736589","Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway","Efficacy and Safety of Inetetamab Combined With Rapamycin and Chemotherapy for HER2-positive Metastatic Breast Cancer Patients With Abnormal Activation of PI3K\u002FAkt\u002FmTOR Pathway After Progression on Trastuzumab.","Inclusion Criteria:\n\n1. Female, Aged \\> 18;\n2. HER2-positive breast cancer are defined as immunohistochemical (IHC) testing as +++, or IHC++ with FISH testing of positive;\n3. Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease.\n4. Patients with HER2-positive metastatic breast cancer who have progressed disease after trastuzumab treatment include the following four types of patients (Note: The following patients are in a parallel relationship):\n\n   1. Patients with HER2-positive breast cancer who have progressed during adjuvant trastuzumab treatment after surgery; or\n   2. Patients with HER2-positive breast cancer who have relapsed or metastasized after receiving adjuvant trastuzumab therapy; or\n   3. HER2-positive recurrent or metastatic BC patients who have progressed after receiving at least 4 weeks of trastuzumab as first-line treatment ; or\n   4. HER2-positive metastatic BC patients who have never been treated have progressed after receiving at least 4 weeks of trastuzumab as first-line treatment.\n5. Genetic testing shows that the PI3K\u002FAkt\u002FmTOR pathway related genes are mutated;\n6. ECOG PS score ≤2, estimated survival time ≥6 months, and can be followed-up;\n7. Patients with measurable disease as per RECIST 1.1 criteria;\n8. Cardiopulmonary function is basically normal, LVEF≥50% within 4 weeks before starting treatment;\n9. An adequate liver function with the following definition:\n\n   1. Total bilirubin ≤ 1.5 times the upper limit of normal value. Patients with known Gibert's disease can be included in the group if combined bilirubin ≤ 1.5 times the upper limit of normal value;\n   2. AST and ALT ≤2.5 times the upper limit of the normal value; if there is liver metastasis, ≤5 times the upper limit of the normal value (the normal value is the normal value specified by this clinical trial center);\n10. Have sufficient baseline hematology parameters, defined as follows:\n\n    1. ANC≥1.5 x 10\\^3 \u002FμL;\n    2. Platelet count ≥100 x 10\\^3\u002FμL, if it is 75-100 x 10\\^3\u002FμL, it may be included in the group, as long as the doctors believe it can be included;\n    3. Hemoglobin ≥9 g\u002FdL.\n11. Coagulation Indicators: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal, unless drugs known to change INR and aPTT are used;\n12. No history of serious heart, kidney and other important organs and endocrine disease;\n13. Female patients of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures;\n14. The patients voluntarily signed an informed consent form.\n\nExclusion Criteria:\n\nAnyone who has one of the following conditions cannot be selected for this trial:\n\n1. Participated in other clinical trials within 4 weeks;\n2. Have used mTOR inhibitors in the past;\n3. Previous use of Pyrotinib in first-line treatment stage; previous use of lapatinib is allowed;\n4. Accompanied by immunosuppressant or chronic corticosteroid medication, or more than 25% bone marrow radiotherapy within 4 weeks;\n5. Symptomatic CNS metastases or evidence of leptomeningeal disease;\n6. Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers);\n7. Hepatitis B or hepatitis C carriers, or other known chronic liver diseases; HIV positive;\n8. Known hypersensitivity to any study medication\n9. Women during pregnancy or lactation;\n10. Left ventricular ejection fraction \\\u003C50%; clinical manifestations of patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease;\n11. Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma;\n12. The researchers decide that any other medical, social or psychological conditions which are inappropriate to participate in this trial.","FEMALE","85 Years",{"count":352,"type":23},270,[354],"PHASE3","This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K\u002FAkt\u002FmTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib plus chemotherapy.The study aimed to access the efficacy and safety of Inetetamab combined with Rapamycin and chemotherapy in HER2-positive metastatic breast cancer patients with abnormal activation of PI3K\u002FAkt\u002FmTOR pathway.",[357],"Breast Cancer",[357,359,360,361],"Inetetamab","Rapamycin","PI3K\u002FAkt\u002FmTOR pathway","2021-01-31",{"date":364,"type":37},"2021-02-03",{"date":366,"type":23},"2021-02-02",{"date":368,"type":23},"2027-02-02",{"name":42,"class":43},""]