💬In plain words
What the trial is, and whether it could suit you
HR20013 is a newly approved medicine in China to prevent nausea and vomiting from anticancer treatment. This prospective, observational, multicenter real-world study will enroll about 3,000 patients receiving this medicine as routine care at over 30 hospitals in China, including 100 with mild to moderate hepatic impairment. Following usual clinical practice, it will evaluate how well the medicine prevents nausea and vomiting and its safety to guide clinical use.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age \>= 18 years, any sex, any tumor type.
2. Planned to receive an antiemetic regimen containing HR20013 prior to anticancer therapy.
3. Scheduled to receive highly emetogenic anticancer therapy, according to the latest Chinese Society of Clinical Oncology (CSCO) guidelines for the prevention and treatment of chemotherapy-induced nausea and vomiting.
4. Written informed consent obtained from the patient.
5. Patients with moderate hepatic impairment enrolled in Cohort 1 are allowed to receive liver-protective treatment prior to anticancer therapy.
Additional criteria for Cohort 1 (mild to moderate hepatic impairment cohort), all of the following must be met:
6. Chronic liver injury caused by primary liver disease (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, or hepatocellular carcinoma; liver metastases or documented liver injury in the medical record are also acceptable), accompanied by at least one of the following abnormal liver function indicators:
1. Aminotransferase elevation: alanine aminotransferase (ALT) \> ULN or aspartate aminotransferase (AST) \> ULN;
2. Abnormal bilirubin metabolism and bile excretion indicators: total bilirubin (TBIL) \> ULN, direct bilirubin (DBIL) \> ULN, indirect bilirubin (IBIL) \> ULN, alkaline phosphatase (ALP) \> ULN, or gamma-glutamyl transpeptidase (GGT) \> ULN;
3. Abnormal hepatic synthetic function indicators: albumin (ALB) \< ULN or total protein (TP) \< ULN;
4. Coagulation indicators: prothrombin time (PT) prolonged by more than 3 seconds or international normalized ratio (INR) \> 1.7;
5. Presence of ascites;
6. Presence of hepatic encephalopathy.
7. Child-Pugh class A or B.
Note: For patients without primary liver disease who only have abnormal liver function indicators, the Child-Pugh classification is not applicable, and these patients will be assigned to Cohort 2.
Exclusion Criteria:
1. Currently participating in other interventional studies.
2. Any other condition deemed unsuitable for participation in this study by the investigator.
3. Pregnant or lactating women.
4. Known hypersensitivity to the study drug or its excipients.
5. Patients with severe hepatic impairment will be excluded from Cohort 2.
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