Chemotherapy-Induced Nausea and Vomiting (CINV)Phase 2NCT07726433
Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV
A Phase 2 study testing Fosrolapitant and Palonosetron Hydrochloride for Injection in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- What is being tested?
- Fosrolapitant and Palonosetron Hydrochloride for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 1 Jun 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form and voluntarily enroll in this study;
- Be at least 18 years of age; gender is not a restriction;
- Be a patient scheduled to receive treatment with Trastuzumab Rezetecan;
- Have an ECOG performance status score of 0-2;
- No ascites or pleural effusion requiring drainage;
- No gastrointestinal obstruction, such as pyloric stenosis or intestinal obstruction;
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- Expected survival of ≥12 weeks;
- Good organ and bone marrow function, defined as follows:
- Hematologic System (No blood transfusions or treatment with hematopoietic growth factors within the past 14 days)
- Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L
- Platelets (PLT) ≥ 100×10⁹/L
- Hemoglobin (Hb) ≥ 90 g/L Liver Function
- Total Bilirubin (TBIL) ≤ 1.5×ULN (For patients with Gilbert's syndrome: ≤ 3×ULN)
- Alanine Aminotransferase (ALT) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)
- Aspartate Aminotransferase (AST) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)
- Albumin (ALB) ≥ 30 g/L Renal Function
- Creatinine (Cr) ≤ 1.5×ULN
- Creatinine Clearance (Ccr)
- (Calculated only when creatinine > 1.5×ULN) Endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula) Cardiac Function
- 12-lead electrocardiogram No severe arrhythmias, and a mean Fridericia-corrected QT interval (QTc) of <450 ms (males) or <470 ms (females)
- Echocardiogram Left ventricular ejection fraction (LVEF) ≥ 50%
- Agree to cooperate in completing daily nausea and vomiting logs and scale assessments;
- Understand the nature of this study; the patient and/or legal guardian voluntarily agree to participate in this trial and sign the informed consent form.
Who cannot join
- Allergy to the study drug or its excipients;
- Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
- Nausea or vomiting at the time of enrollment requiring treatment with antiemetics;
- Use of medications with antiemetic effects within 2 days prior to the first dose;
- Initiation of potent opioid analgesics within 48 hours prior to enrollment (adjustment of the dose of medications already in use is permitted);
- Presence of conditions affecting the assessment of vomiting, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
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- Patients who are difficult to enroll due to clinically diagnosed psychiatric disorders;
- Localized or active systemic infections requiring treatment;
- Pregnant or breastfeeding women, as well as patients of childbearing age who refuse to use appropriate contraceptive measures during the course of this trial;
- Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug (patients who failed screening for other clinical trials may be enrolled in this study);
- Patients with other factors deemed by the investigator to be unsuitable for participation in this study, such as any physiological or psychological conditions that may increase study risks, affect patient adherence to the protocol, or interfere with the patient's ability to complete the trial.
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
Tianjin Cancer Hospital Airport Hospital
Tianjin
Zhansheng Jiang Tianjin Cancer Hospital Airport Hospital, 022-23340123, zhjiang@tmu.edu.cn
About this study
Official title: A Multicenter, Exploratory Clinical Study of the Efficacy and Safety of Phentolamine and Palonosetron for the Prevention of Nausea and Vomiting Associated With Recom-Trastuzumab Therapy
This study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with recanituzumab. All patients who meet the inclusion criteria and do not meet any exclusion criteria are eligible for enrollment in this study and are scheduled to receive targeted therapy, antiemetic treatment, and follow-up.
Dosage Regimen Eligible subjects will receive a prophylactic antiemetic regimen consisting of foslorapitant and palonosetron.
Read more
The dosage regimen is as follows:
Day 1 (D1): Foslorapitant and palonosetron (218 mg foslorapitant and 0.25 mg palonosetron hydrochloride), administered intravenously (IV) 1 hour prior to chemotherapy.
Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.
- Being tested
- Fosrolapitant and Palonosetron Hydrochloride for Injection
- 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
D1: Fosrolapitant and Palonosetron Hydrochloride for Injection (218 mg of pholorapitant and 0.25 mg of palonosetron hydrochloride), IV, administered 1 hour before chemotherapy.
Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Antiemetic Prophylaxis | Experimental | All subjects who meet the inclusion criteria will receive prophylactic antiemetic treatment with Fosrolapitant and Palonosetron Hydrochloride to receiving an infusion of Trastuzumab Rezetecan. During follow-up, investigators will collect data on nausea, vomiting, use of rescue medication, and adverse events to evaluate the efficacy and safety of this hormone-free antiemetic regimen. Receives: Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Complete Response (CR) Rate
The proportion of participants without any vomiting episodes and without receiving rescue antiemetic medication during the overall 0-120 hour period after trastuzumab rezetecan infusion.
Measured: 0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Secondary outcomes (8)
Complete Response (CR) Rate in Acute Phase (0-24 h)
Percentage of participants with no vomiting and no rescue antiemetics within 0-24 hours post trastuzumab rezetecan
Measured: 0 to 24 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Delayed Phase (24-120 h)
Percentage of participants with no vomiting and no rescue antiemetics within 24-120 hours post trastuzumab rezetecan
Measured: 24 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Very Delayed Phase (120-168 h)
Percentage of participants with no vomiting and no rescue antiemetics within 120-168 hours post trastuzumab rezetecan
Measured: 120 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Protection (CP) Rate
Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score <25 mm during observation period
Measured: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Control (TC) Rate
Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score <5 mm during observation period
Measured: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
No Nausea Rate & No Vomiting Rate & No Rescue Medication Rate
No nausea rate: participants with maximum VAS nausea score <5 mm; No vomiting rate: participants with zero vomiting episodes (rescue use allowed); No rescue medication rate: participants who never use rescue antiemetics
Measured: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Rate of Trastuzumab Rezetecan Dose Delay or Reduction Due to Nausea and Vomiting
Percentage of subjects whose trastuzumab rezetecan dose is delayed or reduced caused by treatment-induced nausea and vomiting
Measured: ntire duration of Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Safety Endpoints (Adverse Events, Serious Adverse Events)
Incidence, severity (graded per CTCAE v5.0) and relatedness of all adverse events (AEs), treatment-related AEs, ≥3 grade AEs and serious adverse events (SAEs); changes in vital signs and laboratory parameters
Measured: From informed consent signing to 30 days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Jun 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (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 Vomiting (CINV)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726433
- Sponsor's protocol ID
- CINV-2026-001
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 24 Jul 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Exploratory Clinical Study of the Efficacy and Safety of Phentolamine and Palonosetron for the Prevention of Nausea and Vomiting Associated With Recom-Trastuzumab Therapy
- ClinicalTrials.gov ID
- NCT07726433
- Acronym / sponsor ID
- CINV-2026-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Jul 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 study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with recanituzumab. All patients who meet the inclusion criteria and do not meet any exclusion criteria are eligible for enrollment in this study and are scheduled to receive targeted therapy, antiemetic treatment, and follow-up.
Dosage Regimen Eligible subjects will receive a prophylactic antiemetic regimen consisting of foslorapitant and palonosetron.
The dosage regimen is as follows:
Day 1 (D1): Foslorapitant and palonosetron (218 mg foslorapitant and 0.25 mg palonosetron hydrochloride), administered intravenously (IV) 1 hour prior to chemotherapy.
Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiemetic Prophylaxis | Experimental | Drug: Fosrolapitant and Palonosetron Hydrochloride for InjectionAll subjects who meet the inclusion criteria will receive prophylactic antiemetic treatment with Fosrolapitant and Palonosetron Hydrochloride to receiving an infusion of Trastuzumab Rezetecan. During follow-up, investigators will collect data on nausea, vomiting, use of rescue medication, and adverse events to evaluate the efficacy and safety of this hormone-free antiemetic regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Sign a written informed consent form and voluntarily enroll in this study;
- Be at least 18 years of age; gender is not a restriction;
- Be a patient scheduled to receive treatment with Trastuzumab Rezetecan;
- Have an ECOG performance status score of 0-2;
- No ascites or pleural effusion requiring drainage;
Key exclusion criteria (11 listed)
- Allergy to the study drug or its excipients;
- Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
- Nausea or vomiting at the time of enrollment requiring treatment with antiemetics;
- Use of medications with antiemetic effects within 2 days prior to the first dose;
- Initiation of potent opioid analgesics within 48 hours prior to enrollment (adjustment of the dose of medications already in use is permitted);
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 InjectionD1: Fosrolapitant and Palonosetron Hydrochloride for Injection (218 mg of pholorapitant and 0.25 mg of palonosetron hydrochloride), IV, administered 1 hour before chemotherapy. Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence. | Drug | Antiemetic Prophylaxis |
Primary outcome
Overall Complete Response (CR) Rate
Time frame: 0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
The proportion of participants without any vomiting episodes and without receiving rescue antiemetic medication during the overall 0-120 hour period after trastuzumab rezetecan infusion.
8 secondary outcomes
Complete Response (CR) Rate in Acute Phase (0-24 h)
Time frame: 0 to 24 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Delayed Phase (24-120 h)
Time frame: 24 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Very Delayed Phase (120-168 h)
Time frame: 120 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Protection (CP) Rate
Time frame: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Control (TC) Rate
Time frame: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
No Nausea Rate & No Vomiting Rate & No Rescue Medication Rate
Time frame: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Rate of Trastuzumab Rezetecan Dose Delay or Reduction Due to Nausea and Vomiting
Time frame: ntire duration of Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Safety Endpoints (Adverse Events, Serious Adverse Events)
Time frame: From informed consent signing to 30 days after last study drug 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 24 Jul 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 2 study testing Fosrolapitant and Palonosetron Hydrochloride for Injection in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Tianjin Medical University Cancer Institute and 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 23 inclusion and 11 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 24 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Zhansheng Jiang Tianjin Cancer Hospital Airport Hospital (022-23340123, zhjiang@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Complete Response (CR) Rate (time frame: 0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)). 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 24 Jul 2026.