Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer AgentsPhase 3NCT06554184
HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
A Phase 3 study of Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 706 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to 3 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- 18 years of age or older, of either gender
- Has a histologically or cytologically confirmed malignant disease
- Naïve to cytotoxic chemotherapy
- Scheduled to receive first course of moderate emetic risk anticancer agents
- Predicted life expectancy of ≥ 3 months
- Has a performance status (ECOG scale) of 0 to 1
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- Adequate organ function
- female subjects of childbearing potential must have a negative blood pregnancy test within 72 hours before randomization; and must be non-lactating;
- Able and willing to provide a written informed consent
Who cannot join
- 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
- Scheduled to receive any moderate emetic risk anticancer agents from Day 1 to 6
- Planned to receive treatment with a chemotherapy regimen including ordinary paclitaxel (with castor oil as solvent);
- Medications with potential antiemetic efficacy within 2 days before randomization;
- Began using opioids within 7 days prior to randomization or had a dose adjustment within the last 7 days.
- Systemic corticosteroid therapy or sedative antihistamines within 7 days before randomization;
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- Use of palonosetron within 14 days before randomization;
- Use of NK-1 receptor antagonists within 28 days before randomization;
- 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;
- Vomiting and/or retching and nausea within 24 hours before randomization;
- Subjects with symptomatic brain metastases, or with any symptoms suggestive of brain metastases or intracranial hypertension;
- With uncontrolled serosal effusion;
- Patients with serious cardiovascular diseases;
- Concurrent uncontrolled hypertension before randomization;
- Patients with active hepatitis B, active hepatitis C, acquired immunodeficiency syndrome (AIDS) or HIV test positive, and active syphilis test positive;
- Concomitant diseases where dexamethasone is contraindicated;
- The presence of severe or inadequately controlled diseases;
- Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
- Participation in another clinical trial within 30 days prior to randomization (based on the use of study medication);
- The presence of severe emotional or psychiatric disorders, as assessed by the investigator as unsuitable for participation in this study;
- Subjects who, in the opinion of the investigator, have other conditions that make them inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center Yuexiu Campus
Guangzhou, Guangdong, 510000
About this study
Official title: A Randomized Phase III Study Evaluating the Efficacy and Safety of HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents
- Being tested
- HR20013 + dexamethasone + palonosetron placebo, Palonosetron + dexamethasone + HR20013 placebo
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR20013 + dexamethasone + palonosetron placeboDrug
HR20013 + dexamethasone + palonosetron placebo
Palonosetron + dexamethasone + HR20013 placeboDrug
Palonosetron + dexamethasone + HR20013 placebo
| Study group | Role | What they receive |
|---|---|---|
| HR20013 + dexamethasone + palonosetron placebo | Experimental | Not described Receives: Drug: HR20013 + dexamethasone + palonosetron placebo |
| Palonosetron + dexamethasone + HR20013 placebo | Active comparator | Not described Receives: Drug: Palonosetron + dexamethasone + HR20013 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate in the delayed phase
To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the delayed phase after initiation of moderate emetic risk anticancer agents.
Measured: 24-120 hours after initiation of moderate emetic risk anticancer agents
Secondary outcomes (11)
Complete response rate in the overall phase.
To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the overall phase after initiation of moderate emetic risk anticancer agents.
Measured: 0 - 120 hours after initiation of moderate emetic risk anticancer agents
Complete response rate in the acute phase.
To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the acute phase after initiation of moderate emetic risk anticancer agents.
Measured: 0-24 hours after initiation of moderate emetic risk anticancer agents
Proportion of subjects with no significant nausea (maximum nausea on a visual analogue scale<25 mm)
To compare the proportion of subjects achieving no significant nausea (defined as maximum nausea on a visual analogue scale<25 mm) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Measured: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no nausea (maximum nausea on a visual analogue scale<5 mm)
To compare the proportion of subjects achieving no nausea (defined as maximum nausea on a visual analogue scale<5 mm) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Measured: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no emetic
To compare the proportion of subjects with no emetic event in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Measured: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no rescue medication
To compare the proportion of subjects with no rescue medication in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Measured: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with complete protection
To compare the proportion of subjects achieving complete protection (defined as no emetic episode, no significant nausea and no need for rescue medication) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Measured: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with total control
To compare the proportion of subjects achieving total control (defined as no emetic episode, no nausea and no need for rescue medication) in the acute phase (0-24 hours), the delayed phase (24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Measured: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time to treatment failure
Time to the first occurrence of emetic event or the first rescue medication
Measured: 0-120 hours after initiation of moderate emetic risk anticancer agents
The score using the functional living index-emesis (FLIE) questionnaire
Changes in the score of FLIE before and after treatment
Measured: 0-120 hours after initiation of moderate emetic risk anticancer agents
Adverse events
To analyse the rates of adverse events as assessed by CTCAE v5.0
Measured: Approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start3 Sep 2024
- Primary completion28 Jul 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer AgentsStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554184
- Sponsor's protocol ID
- HR20013-302
- Status last verified
- Oct 2025
- First submitted
- 13 Aug 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study Evaluating the Efficacy and Safety of HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
- ClinicalTrials.gov ID
- NCT06554184
- Acronym / sponsor ID
- HR20013-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HR20013 + dexamethasone + palonosetron placebo | Experimental | Drug: HR20013 + dexamethasone + palonosetron placebo |
| Palonosetron + dexamethasone + HR20013 placebo | Active comparator | Drug: Palonosetron + dexamethasone + HR20013 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older, of either gender
- Has a histologically or cytologically confirmed malignant disease
- Naïve to cytotoxic chemotherapy
- Scheduled to receive first course of moderate emetic risk anticancer agents
- Predicted life expectancy of ≥ 3 months
Key exclusion criteria (21 listed)
- 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
- Scheduled to receive any moderate emetic risk anticancer agents from Day 1 to 6
- Planned to receive treatment with a chemotherapy regimen including ordinary paclitaxel (with castor oil as solvent);
- Medications with potential antiemetic efficacy within 2 days before randomization;
- Began using opioids within 7 days prior to randomization or had a dose adjustment within the last 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR20013 + dexamethasone + palonosetron placeboHR20013 + dexamethasone + palonosetron placebo | Drug | HR20013 + dexamethasone + palonosetron placebo |
| Palonosetron + dexamethasone + HR20013 placeboPalonosetron + dexamethasone + HR20013 placebo | Drug | Palonosetron + dexamethasone + HR20013 placebo |
Primary outcome
Complete response rate in the delayed phase
Time frame: 24-120 hours after initiation of moderate emetic risk anticancer agents
To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the delayed phase after initiation of moderate emetic risk anticancer agents.
11 secondary outcomes
Complete response rate in the overall phase.
Time frame: 0 - 120 hours after initiation of moderate emetic risk anticancer agents
Complete response rate in the acute phase.
Time frame: 0-24 hours after initiation of moderate emetic risk anticancer agents
Proportion of subjects with no significant nausea (maximum nausea on a visual analogue scale<25 mm)
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no nausea (maximum nausea on a visual analogue scale<5 mm)
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no emetic
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no rescue medication
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with complete protection
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with total control
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time to treatment failure
Time frame: 0-120 hours after initiation of moderate emetic risk anticancer agents
The score using the functional living index-emesis (FLIE) questionnaire
Time frame: 0-120 hours after initiation of moderate emetic risk anticancer agents
Adverse events
Time frame: Approximately 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate in the delayed phase (time frame: 24-120 hours after initiation of moderate emetic risk anticancer agents). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.