[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521772":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":13,"interventions":18,"overallOfficials":13,"centralContacts":23,"locations":33,"responsibleParty":56,"collaborators":13,"id":59,"slug":13,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":13,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":13,"studyType":71,"phases":13,"briefSummary":72,"conditions":73,"keywords":13,"overallStatus":36,"whyStopped":13,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Hunan Province Tumor Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"ORR","Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements.","1.5 years",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","advanced solid tumors or lymphomas, NUT rearrangement positive",[19],{"type":20,"name":21,"description":22,"armGroupLabels":13,"otherNames":13},"DRUG","NHWD-870","The base dosage administered is 2.0 mg\u002Fdose\u002Fday, and the frequency and dose of administration may be adjusted based on safety data.",[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"Yongchang Zhang, MD","CONTACT","+8613873123436","7+861383123436","zhangyongchang@csu.edu.cn",{"name":31,"role":26,"phone":27,"phoneExt":13,"email":32},"Nong Yang","yangnong0217@163.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hunan Provincal Tumor Hospital","RECRUITING","Changsha","Hunan","410013","China","CN",{"type":43,"coordinates":44},"Point",[45,46],112.97087,28.19874,{"lat":46,"lon":45},[49,52,54],{"name":50,"role":26,"phone":51,"phoneExt":13,"email":32},"Nong Yang, MD","+86 731 89762323",{"name":25,"role":26,"phone":53,"phoneExt":13,"email":29},"+86 731 89762327",{"name":50,"role":55,"phone":13,"phoneExt":13,"email":13},"PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Yongchang Zhang","Professor, Deputy Director of Thoracic Oncology Department","100521772",false,"NCT06073938","Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement","A Real-World Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement","Inclusion Criteria:\n\n1. Signing an informed consent form;\n2. Patients with advanced solid tumors or lymphomas definitively diagnosed by pathology;\n3. Age ≥18 and ≤75 years;\n4. Eastern Cooperative Oncology Group (ECOG) score physical status score of 0 to 1;\n5. Expected survival of \\>3 months;\n6. NUT positive confirmed by molecular testing.\n\nExclusion Criteria:\n\nSubjects who meet one or more of the following criteria will be excluded:\n\n1. Other serious complications (such as uncontrolled infection, myocardial infarction within 6 months, high blood pressure (≥ 160\u002F100mmHg) and thromboembolic disease that cannot be controlled by drug intervention, etc.);\n2. The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 5.0 ≤ Grade1 (except for hair loss, anemia and other toxicities judged by researchers to be unsafe);\n3. History of substance abuse;\n4. Inability to take drugs due to dysphagia (except for patients who receive nutrients through a gastric tube due to dysphagia), or conditions that the investigator determines seriously affect gastrointestinal absorption;\n5. Patients with a history of other serious systemic diseases who are judged by the investigator to be unsuitable for participating in clinical trials;\n6. Alcoholics or those who drink more than 28 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits or 1 glass of wine);\n7. Suffering from uncontrollable mental illness;\n8. Pregnant or lactating women, or patients of childbearing age (including male subjects) with pregnancy plans;\n9. Active hepatitis B (viral titer \\>103), hepatitis C or HIV ( );\n10. Long-term treatment with high-dose corticosteroids or other immunosuppressants, such as those who have undergone organ transplantation, or those who have received systemic glucocorticoids (such as prednisone\\> 10 mg\u002Fday or equivalent drugs) or other immunosuppressant therapy within 14 days before the first use of the study drug; Exceptions are given for topical, ocular, intra-articular, intranasal and inhaled corticosteroid therapy; short-term use of glucocorticoids for prophylaxis (e.g., prevention of contrast allergy);\n11. The investigator believes that the subject is not suitable to participate in this clinical study for other objective reasons.","ALL","18 Years","75 Years",{"count":69,"type":70},30,"ESTIMATED","OBSERVATIONAL","The NHWD-870 Phase I clinical trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced tumors. The objectives of this retrospective study were to preliminarily evaluate the anti-tumor efficacy of NHWD-870 HCl in patients with advanced solid tumors or lymphomas and to preliminarily evaluate biomarkers associated with the efficacy of NHWD-870 HCl in the treatment of patients with advanced solid tumors or lymphomas, to provide a basis for identifying the enriched population for the late-stage trial.",[74],"Advanced Solid Tumors or Lymphomas","2024-09-17",{"date":77,"type":78},"2024-09-19","ACTUAL",{"date":80,"type":78},"2022-09-20",{"date":82,"type":70},"2025-06-30",{"name":5,"class":6},1]