Prevention of Nausea and Vomiting Caused by Highly Emetogenic ChemotherapyPhase 3NCT05509634

Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors

A Phase 3 study testing HR20013 for injection；dexamethasone and fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone in people with Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
What is being tested?: HR20013 for injection；dexamethasone and fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 754 participants
Where: 1 siteChina
Study dates: 21 Sep 2022to 30 Aug 2023
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 diagnosed malignant tumor
has never been treated with chemotherapy and is to receive the first course of cisplatin-based chemotherapy
Predicted life expectancy of ≥ 3 months
Has a performance status (ECOG scale) of 0 to 1
Adequate bone marrow, kidney, and liver function
Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
Able and willing to provide a written informed consent

Who cannot join

Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
Subjects receiving palonosetron hydrochloride within 14 days before randomization
Subjects who previously received NK-1 receptor antagonists within 28 days prior to randomization
Subjects with a history of myocardial infarction or unstable angina pectoris

Show all 12Show fewer

Subjects with atrioventricular block or cardiac insufficiency
Subjects with poor blood pressure control after medication
Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before randomization
Participated in clinical trials of other drugs (received experimental drugs)
The investigators determined that other conditions were inappropriate for participation in this clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center Yuexiu Campus
Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Compared With Fosaprepitant Dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of HR20013 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.

Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
Being tested: HR20013 for injection；dexamethasone, fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HR20013 for injection；dexamethasoneDrug
HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy
dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasoneDrug
fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy
palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy
dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

Study groups in NCT05509634
Study group	Role	What they receive
Treatment group A	Experimental	HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone Receives: Drug: HR20013 for injection；dexamethasone
Treatment group B	Active comparator	simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone Receives: Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete response during the overall phase after the start of the first cisplatin administration
To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration.
Measured: 0-120 hours after the start of the first cisplatin administration

Secondary outcomes (12)

Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), >120-168 hours, and 0-168 hours after the first cisplatin administration
Complete response during the acute phase, the delayed phase, the overall phase, >120-168 hours, and 0-168 hours after the start of the second cisplatin administration
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours, and 0-168 hours after the start of the second cisplatin administration
No significant nausea
To compare the proportion of subjects with no significant nausea (defined as maximum nausea on a visual analogue scale <25 mm) during the specified period.
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No nausea
To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale <5 mm) during the specified period.
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No emetic
To compare the proportion of subjects with no emetic event during the specified period.
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No rescue medication
To compare the proportion of subjects who received no rescue medication during the specified period.
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Complete protection
To compare the proportion of subjects with complete protection (defined as patients who experienced no emetic event and received no rescue medication and had no significant nausea) during the specified period).
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Total control
To compare the proportion of subjects with total control (defined as patients who experienced no emetic events and received no rescue medication and had no nausea) during the specified period.
Measured: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Time to treatment failure
Time to the first occurrence of emetic event or the first rescue medication.
Measured: During 0-168 hours after the start of each cisplatin administration
The score using the functional living index-emesis (FLIE) questionnaire
To compare the change of score using FLIE questionnaire before and after treatment.
Measured: During 0-168 hours after the start of each cisplatin administration
Number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0
To compare the number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 0 to 504 hours after the start of each cisplatin administration
plasma concentration of HR20013
To analyse the plasma concentration of HR20013 at the specified time points.
Measured: Evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first HR20013 administration, and day 1 of the second HR20013 administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202230 Aug 2023

First posted22 Aug 2022
Study start21 Sep 2022
Primary completion19 Jun 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prevention of Nausea and Vomiting Caused by Highly Emetogenic ChemotherapyStudies 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
Model description: HR20013 for injection + dexamethasone compared with fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 754 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05509634
Sponsor's protocol ID: HR20013-301
Status last verified: Sep 2023
First submitted: 16 Aug 2022
Last updated: 27 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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 39621965

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Compared With Fosaprepitant Dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of HR20013 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy
ClinicalTrials.gov ID: NCT05509634
Acronym / sponsor ID: HR20013-301
Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 754 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Sep 2022 (actual)
Primary completion: 19 Jun 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 22 Aug 2022 (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.

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: HR20013 for injection + dexamethasone compared with fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone

Arm	Type	Receives
Treatment group A	Experimental	Drug: HR20013 for injection；dexamethasoneHR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone
Treatment group B	Active comparator	Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasonesimulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

18 years of age or older, of either gender
Has a diagnosed malignant tumor
has never been treated with chemotherapy and is to receive the first course of cisplatin-based chemotherapy
Predicted life expectancy of ≥ 3 months
Has a performance status (ECOG scale) of 0 to 1

Key exclusion criteria (12 listed)

Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
Subjects receiving palonosetron hydrochloride within 14 days before randomization
Subjects who previously received NK-1 receptor antagonists within 28 days prior to randomization

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 for injection；dexamethasoneHR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy	Drug	Treatment group A
fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasonefosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy	Drug	Treatment group B

Primary outcome

Complete response during the overall phase after the start of the first cisplatin administration
Time frame: 0-120 hours after the start of the first cisplatin administration
To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration.

12 secondary outcomes

Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), >120-168 hours, and 0-168 hours after the first cisplatin administration
Complete response during the acute phase, the delayed phase, the overall phase, >120-168 hours, and 0-168 hours after the start of the second cisplatin administration
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours, and 0-168 hours after the start of the second cisplatin administration
No significant nausea
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No nausea
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No emetic
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No rescue medication
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Complete protection
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Total control
Time frame: the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Time to treatment failure
Time frame: During 0-168 hours after the start of each cisplatin administration
The score using the functional living index-emesis (FLIE) questionnaire
Time frame: During 0-168 hours after the start of each cisplatin administration
Number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 0 to 504 hours after the start of each cisplatin administration
plasma concentration of HR20013
Time frame: Evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first HR20013 administration, and day 1 of the second HR20013 administration

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 27 Oct 2023.
Derived from this study: PubMed 39621965Zhou 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.
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?

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 8 inclusion and 12 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 27 Oct 2023. 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 during the overall phase after the start of the first cisplatin administration (time frame: 0-120 hours after the start of the first cisplatin administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509634, which also lists 1 linked publication.

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 27 Oct 2023.