About this trial
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
Qualifiers
Absolute neutrophil count ≥ 1.5 × 109/L, white blood cell count ≥ 3.0 × 109/L;
Platelet count ≥ 75 × 109/L;
Hemoglobin ≥ 70 g/L;
Aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);
Disqualifiers
Suffering from primary or metastatic malignant tumors of the central nervous system;
Suffering from epilepsy, Parkinson's disease, or other central nervous system disorders that cause nausea and vomiting;
Suffering from intestinal obstruction or other digestive system diseases that may cause nausea and vomiting as determined by researchers;
Suffering from clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.);
Trial design
Treatments tested in this trial
- HSK21542
- HSK21542
- Dolasetron