Chemotherapy-Induced Nausea and Vomiting (CINV)HR20013-RWSNCT07874308
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
An observational study of Chemotherapy-Induced Nausea and Vomiting (CINV) and Nausea, run by Sun Yat-sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea, Vomiting
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age >= 18 years, any sex, any tumor type.
- Planned to receive an antiemetic regimen containing HR20013 prior to anticancer therapy.
- 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.
- Written informed consent obtained from the patient.
- 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:
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- 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:
- Aminotransferase elevation: alanine aminotransferase (ALT) > ULN or aspartate aminotransferase (AST) > ULN;
- 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;
- Abnormal hepatic synthetic function indicators: albumin (ALB) < ULN or total protein (TP) < ULN;
- Coagulation indicators: prothrombin time (PT) prolonged by more than 3 seconds or international normalized ratio (INR) > 1.7;
- Presence of ascites;
- Presence of hepatic encephalopathy.
- 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.
Who cannot join
- Currently participating in other interventional studies.
- Any other condition deemed unsuitable for participation in this study by the investigator.
- Pregnant or lactating women.
- Known hypersensitivity to the study drug or its excipients.
- Patients with severe hepatic impairment will be excluded from Cohort 2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, MD, PhD, 020-87343458, Zhangli6@mail.sysu.edu.cn
About this study
Official title: A Real-World Study of the Efficacy and Safety of HR20013 for the Prevention of Antitumor Therapy-Induced Nausea and Vomiting in Patients With Cancer
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.
Read the detailed description
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.
- Keywords
- chemotherapy-induced nausea and vomiting, real-world study, fosrolapitant/palonosetron
- Medical subject headings
- Vomiting, Nausea, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Mild to Moderate Hepatic Impairment | 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. | |
| Cohort 2: Normal Hepatic Function | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 0 to 120 hours after the start of anticancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start15 Jul 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Induced Nausea and Vomiting (CINV)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874308
- Sponsor's protocol ID
- HR20013-MA-ANT-RWS-010
- Acronym
- HR20013-RWS
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou H, Zhao Y, Zhang M, Yao J, Leng S, Li X, Lin L, Chen J, Zhang S, Qin X, Qin Z, Yi T, Wang R, Li X, Yu Y, Wang Z, Zheng Q, Mei J, Zang A, Li N, Cao F, Cao K, Li W, Lu Y, Lin D, Zhou Y, Yang R, Fang W, Zhou N, Yang Y, Zhang Y, Chen G, Zhou T, Yang X, Wang H, Wang Y, Huang Y, Zhang L. Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. J Clin Oncol. 2025 Mar 20;43(9):1123-1136. doi: 10.1200/JCO-24-01308. Epub 2024 Dec 2.
PubMed 39621965Wilson BE, Jacob S, Yap ML, Ferlay J, Bray F, Barton MB. Estimates of global chemotherapy demands and corresponding physician workforce requirements for 2018 and 2040: a population-based study. Lancet Oncol. 2019 Jun;20(6):769-780. doi: 10.1016/S1470-2045(19)30163-9. Epub 2019 May 8.
PubMed 31078462