HR20013 for preventing nausea and vomiting in cancer patients receiving chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational, multicenter study conducted in China to observe how HR20013 works when used in routine care. About 3,000 cancer patients across more than 30 hospitals will be enrolled, including a subgroup with mild to moderate hepatic impairment. Patients will receive HR20013 as part of standard antiemetic regimens, and outcomes will include patient-reported nausea and vomiting across acute, delayed, and overall periods, along with safety data. Exploratory outcomes will assess quality of life using the FLIE questionnaire. No experimental interventions are imposed beyond normal clinical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Li Zhang, MD, PhD
• Email: Zhangli6@mail.sysu.edu.cn
• Phone: 020-87343458

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.