[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"real-world-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:real-world-study":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,79,112,141,161,186,213,234],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100614423","trimpact-real-world-first-line-atezolizumab-use-in-stage-iv-nsclc-with-pd-l1-50-100614423",false,"NCT07279402","TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%","TRIMPACT: A Prospective Real-World Study of Atezolizumab Monotherapy as First-Line (Stage IV) Treatment in Patients With Non-Small Cell Lung Cancer With PD-L1 Tumor Cell Expression ≥50% and No Targetable Mutations","Inclusion Criteria:\n\n* Signed informed consent form.\n* Diagnosis of stage IV non-small cell lung cancer.\n* Male or female patients aged 18 years or older.\n* Patients who have been prescribed atezolizumab in accordance with routine clinical practice and the locally approved indication in Türkiye.\n* Patients who have received up to 3 cycles of atezolizumab at the screening visit.\n\nExclusion Criteria:\n\n* Patients who are not receiving atezolizumab for the treatment of lung cancer according to standard of care and the approved indication.\n* Known or suspected hypersensitivity to atezolizumab.\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, real-world observational study aims to evaluate the clinical outcomes of first-line atezolizumab monotherapy in patients with stage IV non-small cell lung cancer (NSCLC) with PD-L1 tumor cell expression ≥50% and no targetable mutations. The study aim to determine how atezolizumab performs in routine clinical practice with respect to survival, treatment response, and safety outcomes in this patient population in Türkiye.",[24,25,26,27],"NSCLC Stage IV","PD-L1 Gene Mutation","Atezolizumab","Real World Study",[29],"NSCLC, PD-L1, Atezolizumab, Real World","RECRUITING","2026-04-29",{"date":33,"type":34},"2026-04-30","ACTUAL",{"date":36,"type":34},"2025-09-15",{"date":38,"type":20},"2027-10-01",{"name":40,"class":41},"Antalya Training and Research Hospital","OTHER_GOV",25,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":21,"phases":4,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100601955","validation-of-rcc-predicting-model-with-emulated-target-trial-100601955","NCT07117227","Validation of RCC Predicting Model With Emulated-target Trial","Emulated-target Trial for Guiding Stratified Treatment for Renal Cell Carcinoma With Venous Tumor Thrombus","RCCETT","Inclusion Criteria:\n\n* Adults ≥18 years of age;\n* Diagnosis of primary renal cell carcinoma before and during the surgery;\n* Received radical nephrectomy\u002Fnephron-sparing surgery.\n\nExclusion Criteria:\n\n* Subjects with severely missing clinical information;\n* History of other malignant tumors.\n* Recurrence observed before first postoperative follow-up.\n* Discontinue the adjuvant treatment within in the first two course because of severe adverse react.","80 Years",{"count":53,"type":20},4700,"2 Years","This single-center study utilizes real-world data (2012-2024) from 4700 renal cell carcinoma (RCC) patients at Peking University Third Hospital to: (1) Develop and validate a prognostic prediction model specifically for RCC patients, including those with venous tumor thrombus (VTT); (2) Compare the performance of this new model against existing RCC prediction models in both the overall RCC cohort and the VTT subgroup; (3) Employ an emulated target trial (ETT) methodology to evaluate whether risk-stratified treatment based on the prediction model (grouping patients as high\u002Fmedium\u002Flow risk) improves survival outcomes .",[57,58,59,60,61,27,62],"Renal Cell Carcinoma (Kidney Cancer)","Renal Cell Carcinoma (RCC)","Tumor Thrombus","Prognosis","Prognostic Cancer Model","Observational Study",[64,65,66,67],"renal cell carcinoma","tumor thrombus","prognostic model","emulated-target trial","2026-04-08",{"date":70,"type":34},"2026-04-14",{"date":72,"type":34},"2025-09-01",{"date":74,"type":20},"2027-08-01",{"name":76,"class":77},"Peking University Third Hospital","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":89,"conditions":90,"keywords":98,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":78},"100631522","real-world-evaluation-of-the-implementation-of-lc-oct-in-daily-clinical-practice-100631522","NCT07501780","Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice","Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study","RELI","Inclusion Criteria:\n\n* Patients aged ≥18 years\n* LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands\n* Histopathological results (biopsy or excision) and\u002For 6-12 month clinical follow-up data available\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years of age\n* Cases without histopathological confirmation or available follow-up data",{"count":88,"type":20},297,"Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions.\n\nThis retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.",[91,92,93,94,95,96,97],"Basal Cell Carcinoma of Skin","Optical Coherence Tomography (OCT)","Neoplasms","Neoplasms, Basal Cell","Carcinoma, Basal Cell (BCC)","Real-world Study","Implementation",[99,100,101],"Line-Field Optical Coherence Tomography","Real-world evaluation","Non-melanoma skin cancer","NOT_YET_RECRUITING","2026-03-24",{"date":105,"type":34},"2026-03-30",{"date":107,"type":20},"2026-03-15",{"date":109,"type":20},"2027-12-01",{"name":111,"class":77},"Maastricht University Medical Center",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":78},"100621745","iruplinalkib-in-alk-positive-advanced-lung-adenocarcinoma-after-lorlatinib-100621745","NCT07374614","Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib","An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment","SAILOR","Inclusion Criteria:\n\n1. Population: Male or female patients aged ≥18 years.\n2. Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.\n3. Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).\n4. Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.\n5. Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.\n6. Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.\n7. Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).\n\nExclusion Criteria:\n\n1. Lack of Exposure: Patients who never actually received iruplinalkib or took only a trivial amount (e.g., \\\u003C 1 week\u002Fcycle) before withdrawal for non-medical reasons.\n2. Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).\n3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.\n4. Pregnancy: Pregnant or breastfeeding women.\n5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).",{"count":121,"type":20},20,"This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy. The results are expected to provide real-world evidence to inform clinical decision-making for this heavily pretreated patient population.",[124,125,126,127,96,62],"Non-Small Cell Lung Cancer","ALK","Iruplinalkib","Lorlatinib",[126,129,130,131],"ALK-postive","Post-Lorlatinib","Advanced Lung Adenocarcinoma","2026-01-24",{"date":134,"type":34},"2026-01-29",{"date":136,"type":20},"2026-01-31",{"date":138,"type":20},"2028-12-31",{"name":140,"class":77},"Peking University Shenzhen Hospital",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":78},"100605684","a-real-world-study-of-respiratory-critical-disease-100605684","NCT07165717","A Real World Study of Respiratory Critical Disease.","Inclusion Criteria:\n\n* Patients with underlying diseases associated with high risk of ARDS, including but not limited to: sepsis, pneumonia, multiple trauma, pulmonary contusion, inhalation injury, massive blood transfusion, other high-risk conditions, or other factors causing excessive respiratory drive.\n* Patients meeting the inclusion criteria for a high-risk ARDS population.\n* Patients (or legal representatives) who have provided a signed and dated informed consent form.\n\nExclusion Criteria:\n\n* Age under 18 years.\n* HIV infection.\n* Known immunodeficiency disorders (e.g., leukemia, common variable immunodeficiency, etc.).\n* History of solid organ or bone marrow transplantation.\n* Receiving treatment with G-CSF or GM-CSF.\n* Patients with a decision to withdraw from active treatment.",{"count":148,"type":20},500,"Acute Respiratory Distress Syndrome (ARDS) is a form of acute diffuse lung injury caused by various etiologies, which rapidly progresses to acute respiratory failure. It is characterized by a sudden onset and severe clinical course. Globally, ARDS affects approximately 3 million individuals each year, accounting for about 10% of admissions to intensive care units (ICUs). Due to the lack of specific pharmacological therapies, mechanical ventilation remains the mainstay of treatment. Therefore, identifying and analyzing prognostic factors for ARDS patients is of great significance for improving patient outcomes and reducing the incidence of poor prognosis.",[151,27],"ARDS (Acute Respiratory Distress Syndrome)","2025-09-02",{"date":154,"type":34},"2025-09-10",{"date":156,"type":34},"2019-03-01",{"date":158,"type":20},"2025-12-31",{"name":160,"class":77},"Ming Zhong",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":21,"phases":4,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100598961","the-efficacy-and-safety-of-first-line-treatment-combined-with-immunotherapy-for-advanced-hepatocellular-carcinoma-a-single-center-real-world-study-100598961","NCT07078292","The Efficacy and Safety of First-line Treatment Combined With Immunotherapy for Advanced Hepatocellular Carcinoma: a Single Center, Real-world Study","Inclusion Criteria:\n\n* Age ≥ 18 years old, male or female not limited\n* Non resectable HCC patients diagnosed by tissue\u002Fcytology or imaging that meets the diagnostic criteria for HCC\n* There must be at least one measurable lesion (RECIST 1.1)\n* Use immunotherapy combination therapy as first-line treatment, including atezolizumab+bevacizumab, sintilizumab+bevacizumab analogs, carrelizumab+apatinib, lenvatinib+tirelizumab or sintilizumab, with or without local treatment (including but not limited to TACE, HAIC)\n* Have not received systematic anti-tumor treatment in the past\n* Child Pugh 5-7 points\n* ECOG PS 0-1 points\n* Prospective cohort requires patients to have at least one imaging tumor evaluation since baseline;\n\nExclusion Criteria:\n\n* Lack of baseline data and post-treatment imaging data\n* With other malignant tumors\n* Merge severe cardiovascular diseases and uncontrollable infections\n* Existence of any active autoimmune disease or history of autoimmune disease Expected survival period\\\u003C3 months",{"count":168,"type":20},400,"1 Year","In recent years, immunotherapy represented by PD-1\u002FPD-L1 inhibitors has continuously brought breakthroughs in the treatment of hepatocellular carcinoma and has gradually become the cornerstone of advanced liver cancer treatment. With positive results from the IMbrave-150 study, the combination of atezolizumab and bevacizumab has been approved for first-line treatment of advanced HCC. Subsequently, multiple immune combination therapy regimens were approved one after another, enriching the first-line treatment options for advanced HCC. At present, combination therapy based on immune checkpoint inhibitors has become the mainstream first-line treatment for advanced HCC, and three main treatment modes have been formed: immune combined with bevacizumab, immune combined with TKI, and immune combined with immunity.\n\nMultiple immune combination therapy regimens have shown a flourishing trend in clinical trials, which has brought some thought-provoking issues to the clinical practice of first-line treatment for advanced HCC. On the one hand, the above studies all used sorafenib\u002Flenvatinib monotherapy as a control, lacking a \"head to head\" comparison. In real-world scenarios, how to choose between different treatment options depends on the judgment of clinical doctors and drug accessibility, lacking support from research data. On the other hand, the ORR of immune combination therapy is between 20% and 40%, and there are still a large number of patients who have initial treatment resistance to the above regimen and cannot achieve satisfactory therapeutic effects. How to accurately predict\u002Fidentify the response of different populations to different treatment regimens, and then carry out personalized treatment, is also an important issue facing the first-line treatment of advanced HCC. In addition to systemic anti-tumor therapy, local treatment (such as TACE, HAIC, ablation, radiotherapy, etc.) and surgical treatment are also advantageous weapons for treating advanced HCC, complementing systemic treatment to further improve the prognosis of advanced HCC. However, more clinical research evidence is still needed to support the clinical efficacy data of local treatment combined with systemic treatment in the field of advanced HCC treatment.\n\nBased on the above clinical issues, this study intends to retrospectively and prospectively collect advanced HCC patients who receive first-line immunotherapy in our center, explore the effectiveness and safety of combination therapy based on immune checkpoint inhibitors for first-line treatment of advanced hepatocellular carcinoma in the real world, and reveal the advantageous treatment populations of different immunotherapy regimens (immune+bevacizumab, immune+TKI, immune+immune) in the real world, in order to provide some data reference for the first-line treatment population and regimen selection of advanced HCC.",[172,27],"Hepatocellular Carcinoma (HCC)",[174,175,176],"Hepatocellular Carcinoma","Immunotherapy","Real world study","2025-07-13",{"date":179,"type":34},"2025-07-22",{"date":181,"type":20},"2025-08-01",{"date":183,"type":20},"2027-12-31",{"name":185,"class":77},"Tianjin Medical University Cancer Institute and Hospital",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100581124","ai-assisted-medical-decision-making-100581124","NCT06846229","AI-Assisted Medical Decision-Making","A Cohort Study to Evaluate an Artificial Intelligence Model for Assisting Medical Decision-Making Using Real-Time Hospital-Wide Electronic Health Record Data","Inclusion Criteria:\n\n1. Patients admitted to any department of the hospital (e.g., ICU, general wards, emergency, outpatient services) during the study period.\n2. Patients with available real-time electronic health record (EHR) data, including at least two of the following: laboratory results, vital signs, medical history, and imaging data.\n\nExclusion Criteria:\n\nPatients currently enrolled in another clinical trial that could interfere with data collection or outcomes of this study.",true,{"count":195,"type":20},50000000,"The study builds and applies an AI model to help doctors predict patient diagnoses and outcomes, such as survival or hospital stay. Real-time, multimodal data (labs, vital signs, history, imaging) from hospital records will be used. Patients will be tracked to compare the AI's performance with standard care. The goal is to improve diagnosis and treatment accuracy in a real-world, prospective study.",[96],[199,200,201,202],"diagnosis","prediction","AI","outcome","2025-02-27",{"date":205,"type":34},"2025-03-03",{"date":207,"type":34},"2025-02-24",{"date":209,"type":20},"2026-06",{"name":211,"class":77},"The Eye Hospital of Wenzhou Medical University",2,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":78},"100543878","real-world-study-of-lolatinib-for-advanced-alk-nsclc-patients-100543878","NCT06361589","Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients","Real World Study of Lolatinib for Patients With Advanced\u002FMetastatic Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Voluntary participation in this clinical study, understanding of study procedures, and ability to sign written informed consent.\n2. Age ≥18 years.\n3. Locally advanced or metastatic (inoperable stage IIIa or IIIb-IV) NSCLC with disease staging according to the American Joint Committee on Cancer (AJCC)\u002FUICC 8th edition lung cancer staging criteria.ALK fusion mutations confirmed by tumor histology or hematology.\n4. Expected survival greater than 12 weeks.\n5. Adequate bone marrow reserve, organ function, and coagulation as assessed by the investigator as evidenced by complete blood count, biochemical parameters in blood and urine, coagulation, and electrocardiogram or cardiac ultrasound at baseline.\n6. Can take the medicine orally and swallow it.\n7. Female patients of childbearing potential are willing to use appropriate contraception and should not breastfeed within 6 months from signing the main informed consent to efficacy evaluation\u002Fend of medication (whichever is later); Male patients were willing to use barrier contraception (i.e., condom) for 6 months from signing the main informed consent until the efficacy assessment\u002Fend of medication, whichever occurred later.\n8. Female patients have a negative blood pregnancy test within 3 days before enrollment or meet one of the following criteria to demonstrate no risk of pregnancy: a. Postmenopausal is defined as age 50 years or older and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; b. Females less than 50 years of age may also be considered postmenopausal if they have been amenorrhoeic for 12 months or more after cessation of all exogenous hormonal therapy and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the laboratory postmenopausal reference values; c. History of irreversible sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, except for bilateral tubal ligation.\n\nExclusion Criteria:\n\n1. Use of strong CYP3A4 inhibitors, strong inducers, or drugs with a narrow therapeutic window that are sensitive substrates of CYP3A4 within 7 days and need to continue treatment with these drugs during the study.\n2. Patients with known active infectious diseases, such as active hepatitis B or C or HIV infection of human immunodeficiency virus, active hepatitis B and C including hepatitis B or C surface antigen (+) patients receiving intravenous treatment for infection - patients receiving oral antiviral suppression of hepatitis B or C will be allowed to participate in the study.\n3. Any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition that is not appropriate for the use of lorlatinib, or would affect the interpretation of the study results, or place the patient at high risk.\n4. Female patients who are pregnant, breastfeeding, or plan to become pregnant during the study.\n5. Patients with hypersensitivity to any active or inactive ingredient of lorlatinib.\n6. Any other patient who, in the judgment of the investigator, may have poor compliance with the study procedures and requirements.",{"count":221,"type":20},200,"This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain\u002Fmeningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients.",[224,27],"ALK-positive Non-small Cell Lung Cancer","2024-04-09",{"date":227,"type":34},"2024-04-12",{"date":229,"type":20},"2024-05-01",{"date":231,"type":20},"2028-11-01",{"name":233,"class":77},"Sichuan Cancer Hospital and Research Institute",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100514569","a-real-world-study-of-inetetamab-for-first-line-treatment-of-mbc-100514569","NCT05980208","A Real-world Study of Inetetamab for First-line Treatment of MBC","A Real-world Study of Inetetamab for First-line Treatment of HER2-positive Inoperable Locally Advanced or Relapsed Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients aged ≥18 years and ≤75 years;Patients aged ≥18 years and ≤75 years;\n* Her2-positive invasive breast cancer confirmed by pathological examination met the following conditions:\n\nPositive HER2 expression: Immunohistochemical staining (IHC) showed positive HER2 3+ and\u002For fluorescence in situ hybridization (FISH); Tumor staging: inoperable locally advanced or recurrent metastatic breast cancer; Patients with local recurrence must be confirmed by the investigator to be unable to undergo radical surgical excision.\n\n* At least one measurable lesion was present according to RECIST1.1 criteria;\n* The ECOG score is 0 to 1;\n* No systematic antitumor therapy (except first-line endocrine therapy) has been received at the locally advanced stage (clinically inoperable) or at the stage of recurrence and metastasis;\n* The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocyte enhancing and platelet enhancing drugs) :\n\n  1. Blood routine: neutrophils (ANC) ≥1.5×109\u002FL; Platelet count (PLT) ≥90×109\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n  2. Blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal value (ULN), known patients with Gilbert syndrome, TBIL≤2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN, patients with liver metastasis required ALT and AST≤5×ULN; Alkaline phosphatase ≤2.5×ULN; Urea\u002Furea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;\n  3. Cardiac ultrasound: left ventricular ejection fraction (LVEF) ≥50%;\n  4. 12-lead electrocardiogram: Fridericia corrected QT interval (QTcF) \\\u003C470 msec;\n* Expected survival ≥3 months;\n* Participate in this study voluntarily, sign informed consent, have good compliance and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Known allergic history of drug components of the program;\n* Patients judged unsuitable for systematic chemotherapy by researchers;\n* Use of endocrine therapy drugs within 14 days before baseline;\n* Patients with only bone or skin as target lesions;\n* Other malignancies, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, within the previous 5 years;\n* Peripheral neuropathy ≥ grade 3 according to CTCAE 5.0 criteria;\n* Had received major surgical procedures or significant trauma within 4 weeks prior to randomization, or was expected to receive major surgical treatment;\n* Serious heart disease or discomfort, including but not limited to:\n\nheart failure or contraction dysfunction (LVEF \\\u003C50%) past medical history high risk or the need for treatment of angina or arrhythmia (such as second degree atrioventricular block type 2 or 3 degree atrioventricular block, ventricular tachycardia) clinical significance of heart valve disease ECG showed wall permeability myocardial infarction poorly controlled hypertension, systolic blood pressure\\>150 mmHg and\u002For diastolic blood pressure\\>100 mmHg\n\n* Dysphagia, chronic diarrhea, intestinal obstruction and other factors affecting drug delivery and absorption;\n* A history of immunodeficiency, including HIV infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;\n* Participated in other drug clinical studies within 4 weeks prior to screening;\n* There is a third interstitial effusion (such as pleural fluid and ascites) that cannot be controlled by drainage or other methods;\n* Pregnant or lactating women, women of childbearing age who are unable to take effective contraceptive measures throughout the trial period;\n* Have a serious concomitant disease or other co-medical condition that interferes with planned treatment or any other condition that is not suitable for participation in the study, such as active hepatitis B, lung infection requiring treatment, etc.","75 Years",{"count":19,"type":20},"This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally advanced or recurrent metastatic breast cancer. The research results will provide new targeted treatment strategies for HER2 positive breast cancer patients.",[245,96],"Breast Cancer",[247,248,249,250],"breast cancer","real-world study","HER2-postive","inetetamab","2023-08-06",{"date":253,"type":34},"2023-08-08",{"date":255,"type":20},"2023-09-01",{"date":257,"type":20},"2026-12-31",{"name":259,"class":77},"Hunan Cancer Hospital"]