[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561716":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":11,"centralContacts":33,"locations":11,"responsibleParty":39,"collaborators":11,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":11,"enrollmentInfo":51,"targetDuration":11,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":11,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":11},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"HSK21542-A","EXPERIMENTAL",null,[13],"Drug: HSK21542",{"label":15,"type":10,"description":11,"interventionNames":16},"HSK21542-B",[13],{"label":18,"type":19,"description":11,"interventionNames":20},"Dolasetron","ACTIVE_COMPARATOR",[21],"Drug: Dolasetron",[23,28,30],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","HSK21542","1. HSK21542 injection was administered day 1;\n2. Placebo to match Dorasetron was administered on day 1;\n3. Aprepitant injection was administered on day 1;\n4. Dexamethasone tablets was administered on day 1 to day 4;",[9],{"type":24,"name":25,"description":26,"armGroupLabels":29,"otherNames":11},[15],{"type":24,"name":18,"description":31,"armGroupLabels":32,"otherNames":11},"1. Placebo to match HSK21542 injection was administered day 1;\n2. Dorasetron injection was administered on day 1;\n3. Aprepitant injection was administered on day 1;\n4. Dexamethasone tablets was administered on day 1 to day 4;",[18],[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Shen Xian","CONTACT","13968888872","13968888872@163.com",{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100561716","phase-2-evaluating-the-efficacy-and-safety-of-hsk21542-injection-in-chemotherapy-induced-nausea-and-vomiting-100561716",false,"NCT06593782","Evaluating the Efficacy and Safety of HSK21542 Injection in Chemotherapy-induced Nausea and Vomiting","A Multicenter, Randomized, Double-blind, Active-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)","CINV","Inclusion Criteria:\n\n1.18 years of age or older, of either gender;\n\n2\\. Has never been treated with chemotherapy regimen and plan to receive asingle day high emetic chemotherapy regimen by intravenous infusion，including but not limited to AC regimen, carboplatin AUC ≥ 4, Camustine\\>250 mg\u002Fm2, cisplatin, and other treatment options;\n\n3\\. Diagnosed with a malignant solid tumor by histology or cytology;\n\n4\\. Has an ECOG Performance Status of 0 or 1;\n\n5\\. Predicted life expectancy of ≥3 months;\n\n6\\. Adequate bone marrow, kidney, and liver function:\n\n1. Absolute neutrophil count ≥ 1.5 × 109\u002FL, white blood cell count ≥ 3.0 × 109\u002FL;\n2. Platelet count ≥ 75 × 109\u002FL;\n3. Hemoglobin ≥ 70 g\u002FL;\n4. Aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);\n5. Alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);\n6. Serum total bilirubin ≤ 2 × ULN (≤ 3 × ULN for patients with hepatocellular carcinoma or liver metastasis);\n7. Creatinine ≤ 2 × ULN;\n\n   7\\. Subjects who agree to participate in the trial and voluntarily sign the Informed Consent Form (ICF);\n\nExclusion Criteria:\n\n1. History or evidence of any of the following diseases prior to screening:\n\n   1. Suffering from primary or metastatic malignant tumors of the central nervous system;\n   2. Suffering from epilepsy, Parkinson\\'s disease, or other central nervous system disorders that cause nausea and vomiting;\n   3. Suffering from intestinal obstruction or other digestive system diseases that may cause nausea and vomiting as determined by researchers;\n   4. Suffering from clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.);\n   5. History of obvious and chronic dizziness;\n   6. QT interval\\>450 ms during screening or taking concomitant medications due to prolonged QT interval or has risk factors for QT interval prolongation or correspon;\n2. Allergies or contraindications to the study drugs or other drugs specified in the protocol (including chemotherapy drugs, investigational drugs and mimetics, dorasetron, aripipitan, dexamethasone, etc.) ;\n3. Subjects who have experienced nausea, retching, or vomiting before 24 hours of randomization;\n4. Subjects who have received abdominal or pelvic radiation therapy within the first 7 days of randomization or plan to receive abdominal or pelvic radiation therapy during the study period;\n5. Subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming \\>2 units of alcohol on average daily (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol or 150 mL of wine);\n6. Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 1 month prior to screening;\n7. Female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion;\n8. Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.","ALL","18 Years",{"count":52,"type":53},180,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","This is a multicenter, randomized, double-blind, active-controlled dose-finding study. About 180 subjects who receive a high emetic chemotherapy are planned to be enrolled and randomized into three groups by a ratio of 1:1:1.",[59],"Nausea and Vomiting, Chemotherapy-Induced","NOT_YET_RECRUITING","2024-09-17",{"date":63,"type":64},"2024-09-19","ACTUAL",{"date":66,"type":53},"2024-09-16",{"date":68,"type":53},"2025-09-01",{"name":5,"class":6}]