Chemotherapy-induced Nausea and VomitingPhase 4NCT07482891
An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC
A Phase 4 study testing Fosrolapitant and Palonosetron Hydrochloride for Injection, Dexamethasone and Olanzapine in people with Chemotherapy-induced Nausea and Vomiting, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
This prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Fosrolapitant and Palonosetron Hydrochloride for Injection, Dexamethasone and Olanzapine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, any gender, voluntarily signed informed consent form (ICF), with good compliance;
- Histologically or cytologically confirmed malignant solid tumour;
- No prior exposure to any chemotherapeutic agents;
- First-time participants with malignant solid tumours scheduled to receive a treatment regimen based on multi-day HEC chemotherapy (HEC refers to the risk of anti-tumour drug-induced nausea and vomiting as defined in the 2023 Edition of the Chinese Guidelines for the Prevention and Treatment of Nausea and Vomiting Associated with Anti-tumour Therapy; 'multi-day' denotes each chemotherapy cycle lasting at least 3 days);
- No impairment in speech, hearing, or comprehension;
- Expected survival ≥ 3 months;
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- ECOG : 0-1;
- Organ function must be adequate and meet the following criteria:
- Neutrophil count ≥ 1.5 × 10⁹/L;
- Haemoglobin ≥ 90 g/L;
- Platelet count ≥ 100 × 10⁹/L;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
- In patients without known liver metastases, aspartate aminotransferase ≤ 2.5 × ULN and/or alanine aminotransferase ≤ 2.5 × ULN (for patients with liver metastases, may be relaxed to ≤ 5 × ULN);
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 ml/min;
- Electrocardiogram: QTc ≤ 450 ms (males), QTc ≤ 470 ms (females);
- Echocardiogram: LVEF (left ventricular ejection fraction) ≥ 50%.
- Female subjects of childbearing potential, and male subjects with female partners of childbearing potential, must use one form of effective contraception from the time of signing the informed consent form until 6 months after the last dose (see Appendix). Female subjects of childbearing potential must have a negative blood pregnancy test within 72 hours prior to enrolment and must not be breastfeeding.
Who cannot join
- Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
- Subjects who have received radiotherapy within 7 days prior to enrolment, extensive radiotherapy (e.g., whole-chest or whole-abdomen radiotherapy) within 3 months prior to enrolment, local palliative radiotherapy (e.g., for bone or lymph node metastases) within 1 month prior to enrolment, or who are scheduled to undergo any radiotherapy during the study period;
- Administration within 2 days prior to enrolment of medications with potential antiemetic effects: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, or secloperazine;
- Initiation of benzodiazepine or opioid therapy within 2 days prior to enrolment (excluding zolpidem, temazepam, or midazolam administered alone daily);
- Subjects who commenced morphine use within 7 days prior to enrolment (excluding those on stable doses);
- Systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone) or sedating antihistamines (e.g., diphenhydramine) administered within 7 days prior to enrolment (Note: Single-dose steroids for contrast allergy prophylaxis, or topical/inhaled administration are permitted);
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- Use of palonosetron within 14 days prior to enrolment;
- Use of NK-1 receptor antagonists within 28 days prior to enrolment;
- Vomiting and/or retching, nausea occurring within 24 hours prior to enrolment;
- Presence of poorly controlled serosal effusions, including pleural effusion, ascites, pericardial effusion (exclusion may be waived if controlled by treatment and stable for ≥2 weeks);
- Severe cardiovascular disease within 3 months prior to enrolment, including but not limited to acute myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association [NYHA] Class II to IV), or history of severe cardiac conduction abnormalities (e.g., torsades de pointes ventricular tachycardia);
- Concurrent active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), active hepatitis C (HCV-Ab positive with HCV-RNA ≥ ULN), known acquired immunodeficiency syndrome (AIDS) or HIV-positive status, or syphilis-positive status;
- Concurrent conditions precluding dexamethasone administration, such as active infections (e.g., pneumonia) or uncontrolled conditions (e.g., diabetic ketoacidosis, intestinal obstruction);
- Known contraindications and/or allergies to study medications;
- Participation in another clinical trial within 30 days prior to enrolment (as determined by the use of study medication);
- Subjects deemed by the investigator to have other conditions rendering them unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Xiuli Zhang, PhD, +86 15021092607, qyzhangxiuli@126.com
About this study
Official title: An Exploratory Study on the Efficacy and Safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in Preventing Nausea and Vomiting Caused by Highly Emetogenic Multi-Agent Chemotherapy
This prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Eligible subjects were screened and assigned to Arm 1 or Arm 2 according to medical protocol. Arm 1: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine; Arm 2: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone. Study drug administration commenced within 48 hours post-randomization, with follow-up visits and examinations completed as per protocol.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Fosrolapitant and Palonosetron Hydrochloride for Injection, Dexamethasone, Olanzapine
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosrolapitant and Palonosetron Hydrochloride for InjectionDrug
On the first day of chemotherapy, a 60-minute intravenous infusion is administered prior to treatment
DexamethasoneDrug
On the first day of chemotherapy, take 12mg orally. From the second day of chemotherapy until 3 days after chemotherapy concludes, take 3.75mg orally twice daily
OlanzapineDrug
From the first day of chemotherapy until three days after its completion, take 5mg orally each night before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine | Experimental | Not described Receives: Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection; Drug: Dexamethasone; Drug: Olanzapine |
| Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone | Experimental | Not described Receives: Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving Complete Control of CINV from the first administration until 24 hours after the last administration of chemotherapy
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) from the first administration until 24 hours after the last administration of chemotherapy
Measured: from the first administration until 24 hours after the last administration of chemotherapy
Secondary outcomes (8)
Percentage of patients achieving Complete Control of CINV during the acute phase, delayed phase, and super-delayed phase
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: acute phase: from first chemotherapy administration until last administration; delayed phase: until 120 hours after last administration; super-delayed phase: from 120 hours to 168 hours after last 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: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last 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: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No emetic
To compare the proportion of subjects with no emetic event during the specified period
Measured: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No rescue medication
To compare the proportion of subjects who received no rescue medication during the specified period.
Measured: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last 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: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last 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: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last 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: from first chemotherapy administration to 168 hours after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start10 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Zan, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482891
- Sponsor's protocol ID
- 2026-012
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Efficacy and Safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in Preventing Nausea and Vomiting Caused by Highly Emetogenic Multi-Agent Chemotherapy
- ClinicalTrials.gov ID
- NCT07482891
- Acronym / sponsor ID
- 2026-012
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (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 prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Eligible subjects were screened and assigned to Arm 1 or Arm 2 according to medical protocol. Arm 1: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine; Arm 2: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone. Study drug administration commenced within 48 hours post-randomization, with follow-up visits and examinations completed as per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine | Experimental | Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection, Drug: Dexamethasone, Drug: Olanzapine |
| Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone | Experimental | Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 18-75 years, any gender, voluntarily signed informed consent form (ICF), with good compliance;
- Histologically or cytologically confirmed malignant solid tumour;
- No prior exposure to any chemotherapeutic agents;
- First-time participants with malignant solid tumours scheduled to receive a treatment regimen based on multi-day HEC chemotherapy (HEC refers to the risk of anti-tumour drug-induced nausea and vomiting as defined in the 2023 Edition of the Chinese Guidelines for the Prevention and Treatment of Nausea and Vomiting Associated with Anti-tumour Therapy; 'multi-day' denotes each chemotherapy cycle lasting at least 3 days);
- No impairment in speech, hearing, or comprehension;
Key exclusion criteria (16 listed)
- Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
- Subjects who have received radiotherapy within 7 days prior to enrolment, extensive radiotherapy (e.g., whole-chest or whole-abdomen radiotherapy) within 3 months prior to enrolment, local palliative radiotherapy (e.g., for bone or lymph node metastases) within 1 month prior to enrolment, or who are scheduled to undergo any radiotherapy during the study period;
- Administration within 2 days prior to enrolment of medications with potential antiemetic effects: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, or secloperazine;
- Initiation of benzodiazepine or opioid therapy within 2 days prior to enrolment (excluding zolpidem, temazepam, or midazolam administered alone daily);
- Subjects who commenced morphine use within 7 days prior to enrolment (excluding those on stable doses);
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 |
|---|---|---|
| Fosrolapitant and Palonosetron Hydrochloride for InjectionOn the first day of chemotherapy, a 60-minute intravenous infusion is administered prior to treatment | Drug | Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone, Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine |
| DexamethasoneOn the first day of chemotherapy, take 12mg orally. From the second day of chemotherapy until 3 days after chemotherapy concludes, take 3.75mg orally twice daily | Drug | Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone, Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine |
| OlanzapineFrom the first day of chemotherapy until three days after its completion, take 5mg orally each night before bedtime | Drug | Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine |
Primary outcome
Percentage of patients achieving Complete Control of CINV from the first administration until 24 hours after the last administration of chemotherapy
Time frame: from the first administration until 24 hours after the last administration of chemotherapy
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) from the first administration until 24 hours after the last administration of chemotherapy
8 secondary outcomes
Percentage of patients achieving Complete Control of CINV during the acute phase, delayed phase, and super-delayed phase
Time frame: acute phase: from first chemotherapy administration until last administration; delayed phase: until 120 hours after last administration; super-delayed phase: from 120 hours to 168 hours after last administration
No significant nausea
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No nausea
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No emetic
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No rescue medication
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
Complete protection
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
Total control
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
The score using the functional living index-emesis (FLIE) questionnaire
Time frame: from first chemotherapy administration to 168 hours after last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fosrolapitant and Palonosetron Hydrochloride for Injection, Dexamethasone and Olanzapine in people with Chemotherapy-induced Nausea and Vomiting, run by Shanghai 6th People's Hospital 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 17 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving Complete Control of CINV from the first administration until 24 hours after the last administration of chemotherapy (time frame: from the first administration until 24 hours after the last administration of chemotherapy). 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 30 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.