An observational study in Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea and Vomiting, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Sun Yat-sen University · Observational
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.
This is a prospective, observational, multicenter real-world study conducted at more than 30 hospitals in China. Approximately 3,000 patients with cancer who receive at least one dose of HR20013 (218 mg/0.25 mg intravenous infusion) for prevention of chemotherapy-induced nausea and vomiting will be enrolled, including Cohort 1 (n=100, patients with mild to moderate hepatic impairment per Child-Pugh classification) and Cohort 2 (n=2,900, patients without hepatic impairment). All diagnoses, treatments, visits and examinations follow routine clinical practice; no study-mandated interventions are applied. The primary data include patient-reported nausea and vomiting episodes (NCI-CTCAE v6.0) in the acute (0-24 h), delayed (24-120 h and 120-168 h) and overall phases (0-120 h), and adverse drug reactions. Exploratory outcomes include quality of life measured by the FLIE (Functional Living Index-Emesis) questionnaire.
1,123 studies on the registry are indexed under Vomiting; 137 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 160 across 128 observational studies indexed under Vomiting.
Browse Vomiting studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Adult patients (aged 18 years or older, any sex, any tumor type) who are scheduled to receive highly emetogenic anticancer therapy and will be given an antiemetic regimen containing HR0013 prior to anticancer treatment for prevention of chemotherapy-induced nausea and vomiting. All participants are recruited from routine clinical practice at more than 30 hospitals across China, with a planned total of approximately 3,000 patients. The study population is divided into two cohorts: Cohort 1 consists of approximately 100 patients with mild to moderate hepatic impairment (Child-Pugh class A or B) due to primary liver disease; Cohort 2 consists of approximately 2,900 patients without hepatic impairment. Patients are eligible regardless of their chemotherapy line or prior antiemetic exposure, provided they are not participating in other interventional studies and have no contraindications to the study drug.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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:
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:
Patients with cancer and mild to moderate hepatic impairment (Child-Pugh score 5-9) who receive HR20013 (218 mg/0.25 mg) intravenous infusion before anticancer therapy for prevention of chemotherapy-induced nausea and vomiting. Planned enrollment: 100.
Patients with cancer without hepatic impairment who receive fosrolapitant/palonosetron (218 mg/0.25 mg) single-agent or in combination for prevention of chemotherapy-induced nausea and vomiting. Planned enrollment: 2,900.
Incidence of Drug-Related Adverse Events of Any Grade
Number of participants with any grade of drug-related adverse events (ADRs) during the study, graded according to NCI-CTCAE v6.0.
Time frame: From the first administration of HR20013 on Day 1 of Cycle 1 through 30 days after the last administration of HR20013 (each treatment cycle is 21 days)
Incidence and Severity of Nausea/Vomiting in the Acute Phase
Proportion of participants with nausea or vomiting and the corresponding severity, graded according to NCI-CTCAE v6.0.
Time frame: Within 24 hours after the start of anticancer therapy
Incidence and Severity of Nausea/Vomiting in the Delayed Phase
Proportion of participants with nausea or vomiting and the corresponding severity, graded according to NCI-CTCAE v6.0.
Time frame: From 24 to 120 hours after the start of anticancer therapy
Incidence and Severity of Nausea/Vomiting in the Ultra-Delayed Phase
Proportion of participants with nausea or vomiting and the corresponding severity, graded according to NCI-CTCAE v6.0.
Time frame: From 120 to 168 hours after the start of anticancer therapy
Incidence and Severity of Nausea/Vomiting in the Overall Phase
Proportion of participants with nausea or vomiting and the corresponding severity, graded according to NCI-CTCAE v6.0.
Time frame: From 0 to 120 hours after the start of anticancer therapy
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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