Malignant solid tumor
Conditions
Interventions
Experimental group:30 minutes +/- 10 minutes before the start of high emetogenic chemotherapy drug infusion, the study drug administration before chemotherapy is completed. The administration plan is
Sponsors
Shao Yi Fu Hospital Affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not limited. 2. Histological or cytological diagnosis of malignant solid tumor. 3. Planned to receive a single-day intravenous anti-tumor drug treatment regimen, and the regimen includes chemotherapy drugs with high emetogenic risk, including but not limited to AC combination regimen (including anthracycline and cyclophosphamide combination regimen), cyclophosphamide > 1500 mg/m^2, ifosfamide >= 2 g/m^2 (each dose), carboplatin AUC >= 4, dacarbazine, streptozotocin, carmustine > 250 mg/m^2, doxorubicin >= 60 mg/m^2, goserelin, cisplatin, azacitidine, deruxetinib, etc. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Expected survival period >= 3 months. 6. The subjects have sufficient bone marrow, renal and liver functions: a) Absolute neutrophil count >= 1.5 × 10^9/L, white blood cell count >= 3.0 × 10^9/L; b) Platelet count >= 75 × 10^9/L; c) Hemoglobin >= 70 g/L; d) Aspartate aminotransferase (AST) <= 3 × ULN (patients without liver cancer or tumor liver metastasis) or 5 × ULN (patients with liver cancer or tumor liver metastasis); e) Alanine aminotransferase (ALT) <= 3 × ULN (patients without liver cancer or tumor liver metastasis) or 5 × ULN (patients with liver cancer or tumor liver metastasis); f) Bilirubin <= 2 × ULN (patients without liver cancer or tumor liver metastasis) or 3 × ULN (patients with liver cancer or tumor liver metastasis); g) Creatinine <= 2 × ULN. 7. Agree to participate in this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with the following current medical history before screening: a) Have active primary or metastatic central nervous system malignancies; b) Have epilepsy, Parkinson's disease, or other central nervous system disorders causing nausea and vomiting; c) Have intestinal obstruction or other digestive system disorders that may cause nausea and vomiting as judged by the investigator; d) Have vestibular dysfunction (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.) that has been clearly diagnosed; e) Have a history of obvious and chronic dizziness; f) Have a QT interval > 450 ms at screening, or are taking concomitant drugs due to QT interval prolongation or have risk factors for QT interval prolongation or corresponding arrhythmia events (heart failure, hyperkalemia, history or family history of long QT syndrome); 2. Those who are allergic or have contraindications to the study drugs as specified in the protocol (including: chemotherapy drugs, dolasetron, NK-1RA, dexamethasone, etc.); 3. Subjects who have experienced nausea, dry vomiting or vomiting within 24 hours before randomization; 4. Subjects who have a history of drug abuse, drug use, or alcohol abuse within 3 months before screening; 5. Subjects who have received, or plan to receive abdominal or pelvic radiotherapy during the study period; 6. Subjects who plan to receive high emetogenic chemotherapy drugs again within 5 days after the infusion of high emetogenic chemotherapy drugs; 7. Subjects who plan to receive high emetogenic chemotherapy drugs for multiple days within one chemotherapy cycle; 8. Subjects who have received or plan to receive other drugs that affect the assessment of nausea and vomiting before chemotherapy, including but not limited to benzodiazepines, opioids, systemic glucocorticoid drugs, and have not exceeded 5 half-lives; 9. Subjects who have received or plan to receive other drugs that affect the assessment of nausea and vomiting before chemotherapy, during the study period, including but not limited to benzodiazepines, opioids, systemic glucocorticoid drugs, and have not exceeded 5 half-lives; 10. Subjects who have received or plan to receive specific CYP3A4 substrates/CYP3A4 inhibitors (pimozide, teriflunomide, asamizole, and cisapride) before chemotherapy, and have not exceeded 5 half-lives; 11. Subjects who have participated in any clinical studies within 3 months before screening (defined as receiving the investigational drug or placebo); 12. Subjects with active hepatitis B, hepatitis C, positive syphilis test, or positive HIV test; 13. Pregnant and lactating women; subjects who are willing to use contraception throughout the study period and within 3 months after the study ends (including male subjects); 14. Other vulnerable groups, such as critically ill patients, patients with mental illness, patients with cognitive impairment, etc.; 15. Subjects who, in the opinion of the investigator, have any other factors that make them unsuitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response rate (CR) of high emetogenic drugs within the period from 0 h to 120 h after administration (the overall stage) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The response rate (CR) of highly emetogenic drugs within 0 h - 24 h after administration (acute phase);The proportion of subjects without nausea (with nausea VAS score = 5mm) and with mild nausea (with nausea VAS score = 25mm) within 0 h - 24 h and 24 h - 120 h after administration of highly emetic drugs;The proportion of subjects who did not experience vomiting (vomiting [even if only a small amount of gastric contents was expelled] or dry vomiting [muscular movements of vomiting but no expulsion of gastric contents]) within 0 h - 24 h and 24 h - 120 h after administration of highly emetic drugs (Note: The term "dry vomiting" is not commonly used in English medical literature; it might be better to use "vomiting" or "dry vomiting" depending on the context.);The proportion of subjects who used rescue drugs after administration of highly emetogenic drugs from 0 h to 24 h and from 24 h to 120 h;Within 120 hours after administration of highly emetic drugs, the time of the first occurrence of vomiting (vomiting or dry heaving) or the time of administration of remedial treatment (whichever occurs first);The severity of nausea (measured by VAS scale) 24 h ± 1 h after administration of highly emetogenic drugs;The incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactCai Bin
Shao Yi Fu Hospital Affiliated to Zhejiang University School of Medicine
Outcome results
None listed