evaluating the efficacy and safety of hsk21542 injection in chemotherapy-induced nausea and vomiting

Conditions: Nausea and Vomiting, Chemotherapy-Induced

Summary: 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.


Eligibility criteria:
inclusion criteria: 1.18 years of age or older, of either gender; 2. 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\&amp;amp;gt;250 mg/m2, cisplatin, and other treatment options; 3. diagnosed with a malignant solid tumor by histology or cytology; 4. has an ecog performance status of 0 or 1; 5. predicted life expectancy of ≥3 months; 6. adequate bone marrow, kidney, and liver function: 1. absolute neutrophil count ≥ 1.5 × 109/l, white blood cell count ≥ 3.0 × 109/l; 2. platelet count ≥ 75 × 109/l; 3. hemoglobin ≥ 70 g/l; 4. aspartate transaminase (ast) ≤ 3 × uln (≤ 5 × uln in patients with hepatocellular carcinoma or liver metastasis); 5. alanine transaminase (alt) ≤ 3 × uln (≤ 5 × uln in patients with hepatocellular carcinoma or liver metastasis); 6. serum total bilirubin ≤ 2 × uln (≤ 3 × uln for patients with hepatocellular carcinoma or liver metastasis); 7. creatinine ≤ 2 × uln; 7. subjects who agree to participate in the trial and voluntarily sign the informed consent form (icf); exclusion criteria: 1. history or evidence of any of the following diseases prior to screening: 1. suffering from primary or metastatic malignant tumors of the central nervous system; 2. suffering from epilepsy, parkinson\&amp;amp;amp;amp;#39;s disease, or other central nervous system disorders that cause nausea and vomiting; 3. suffering from intestinal obstruction or other digestive system diseases that may cause nausea and vomiting as determined by researchers; 4. suffering from clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.); 5. history of obvious and chronic dizziness; 6. qt interval\&amp;amp;amp;amp;gt;450 ms during screening or taking concomitant medications due to prolonged qt interval or has risk factors for qt interval prolongation or correspon; 2. 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.) ; 3. subjects who have experienced nausea, retching, or vomiting before 24 hours of randomization; 4. 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; 5. 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); 6. subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 1 month prior to screening; 7. 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; 8. subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.