Can a Two-Drug cocktail stop Chemo-Linked nausea before it starts?

NCT ID NCT07726433

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial is testing whether a combination of two drugs, fosrolapitant and palonosetron, can prevent nausea and vomiting in cancer patients receiving trastuzumab rezetecan therapy. About 56 adults scheduled for this targeted treatment will receive the antiemetic combination intravenously before chemotherapy. Researchers will track vomiting episodes and nausea severity over two treatment cycles to see if the regimen works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of fosrolapitant and palonosetron hydrochloride given as an IV injection
What this could lead to
If effective, this antiemetic regimen could offer a new way to prevent nausea and vomiting in patients receiving trastuzumab rezetecan, improving treatment tolerability.
What could go wrong
This is a small, early-phase exploratory trial without a placebo group, so results may not confirm effectiveness. Side effects from the antiemetic drugs themselves 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Sign a written informed consent form and voluntarily enroll in this study; 2. Be at least 18 years of age; gender is not a restriction; 3. Be a patient scheduled to receive treatment with Trastuzumab Rezetecan; 4. Have an ECOG performance status score of 0-2; 5. No ascites or pleural effusion requiring drainage; 6. No gastrointestinal obstruction, such as pyloric stenosis or intestinal obstruction; 7. Expected survival of ≥12 weeks; 8. 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% 9. Agree to cooperate in completing daily nausea and vomiting logs and scale assessments; 10. 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. Exclusion Criteria: 1. Allergy to the study drug or its excipients; 2. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone; 3. Nausea or vomiting at the time of enrollment requiring treatment with antiemetics; 4. Use of medications with antiemetic effects within 2 days prior to the first dose; 5. Initiation of potent opioid analgesics within 48 hours prior to enrollment (adjustment of the dose of medications already in use is permitted); 6. Presence of conditions affecting the assessment of vomiting, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction; 7. Patients who are difficult to enroll due to clinically diagnosed psychiatric disorders; 8. Localized or active systemic infections requiring treatment; 9. Pregnant or breastfeeding women, as well as patients of childbearing age who refuse to use appropriate contraceptive measures during the course of this trial; 10. 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); 11. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chemotherapy-induced nausea and vomiting (CINV) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Cancer Hospital Airport Hospital

    RECRUITING

    Tianjin, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.