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3,000-Patient study tracks Anti-Nausea drug in routine cancer care

NCT ID NCT07874308

Symptom relief Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 14, 2026 · Last updated Oct 15, 2026 · Updated 1 time

Summary

Researchers in China are observing how well the approved medicine HR20013 prevents nausea and vomiting caused by anticancer treatment. The study plans to follow about 3,000 adults with any tumor type who receive HR20013 as part of their usual care at more than 30 hospitals. It will track side effects and how often nausea or vomiting occurs during the acute and delayed phases after treatment, including in a small group of patients with mild to moderate liver impairment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HR20013, an approved medicine given before anticancer treatment to prevent nausea and vomiting
What this could lead to
If HR20013 controls nausea and vomiting well in everyday cancer care, doctors could gain clearer guidance on how to use it across different patients, including those with liver problems.
What could go wrong
This is an observational study, not a randomized experiment, so it can show patterns but cannot prove cause and effect. Results may not apply to patients outside the hospitals studied or to those with severe liver impairment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

cancer Nausea neoplasm Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy-induced nausea and vomiting (CINV) Nausea Neoplasms Vomiting

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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