Can a Two-Drug cocktail stop Chemo-Linked nausea before it starts?
NCT ID NCT07726433
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tianjin Cancer Hospital Airport Hospital
RECRUITINGTianjin, China
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