New pill aims to stop Chemo-Induced nausea in its tracks
NCT ID NCT06554184
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called HR20013 to see if it works better than an existing drug (palonosetron) at preventing nausea and vomiting caused by moderate-risk chemotherapy. Over 700 cancer patients who had never had chemo before took part. The main goal was to see how many patients had no vomiting and didn't need extra medication in the delayed phase (24-120 hours after chemo).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HR20013 (a drug to prevent nausea and vomiting)
- What this could lead to
- If it works, this could offer a new option to prevent nausea and vomiting after chemotherapy, improving comfort for cancer patients.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The drug may not be more effective than existing treatments, and side effects are possible.
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.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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706 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. 18 years of age or older, of either gender 2. Has a histologically or cytologically confirmed malignant disease 3. Naïve to cytotoxic chemotherapy 4. Scheduled to receive first course of moderate emetic risk anticancer agents 5. Predicted life expectancy of ≥ 3 months 6. Has a performance status (ECOG scale) of 0 to 1 7. Adequate organ function 8. female subjects of childbearing potential must have a negative blood pregnancy test within 72 hours before randomization; and must be non-lactating; 9. Able and willing to provide a written informed consent Exclusion Criteria: 1. Received or planned to receive total body irradiation, or radiation therapy to the abdomen, pelvis, Whole brain and spinal cord, head and neck , or chest within 7 days before randomization or within Days 1 to 8 of treatment 2. Scheduled to receive any moderate emetic risk anticancer agents from Day 1 to 6 3. Planned to receive treatment with a chemotherapy regimen including ordinary paclitaxel (with castor oil as solvent); 4. Medications with potential antiemetic efficacy within 2 days before randomization; 5. Began using opioids within 7 days prior to randomization or had a dose adjustment within the last 7 days. 6. Systemic corticosteroid therapy or sedative antihistamines within 7 days before randomization; 7. Use of palonosetron within 14 days before randomization; 8. Use of NK-1 receptor antagonists within 28 days before randomization; 9. Use of moderate to strong CYP3A4 inhibitors within 7 days before randomization; use of moderate to strong CYP3A4 inducers or specific CYP2D6 substrates within 28 days before randomization; 10. Vomiting and/or retching and nausea within 24 hours before randomization; 11. Subjects with symptomatic brain metastases, or with any symptoms suggestive of brain metastases or intracranial hypertension; 12. With uncontrolled serosal effusion; 13. Patients with serious cardiovascular diseases; 14. Concurrent uncontrolled hypertension before randomization; 15. Patients with active hepatitis B, active hepatitis C, acquired immunodeficiency syndrome (AIDS) or HIV test positive, and active syphilis test positive; 16. Concomitant diseases where dexamethasone is contraindicated; 17. The presence of severe or inadequately controlled diseases; 18. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone; 19. Participation in another clinical trial within 30 days prior to randomization (based on the use of study medication); 20. The presence of severe emotional or psychiatric disorders, as assessed by the investigator as unsuitable for participation in this study; 21. Subjects who, in the opinion of the investigator, have other conditions that make them inappropriate for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center Yuexiu Campus
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.