RecruitingPhase 4NCT07482891

An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC

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


Sponsor

Shanghai 6th People's Hospital

Enrollment

200 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dexamethasone, a drug called Fosrolapitant and Palonosetron Hydrochloride for Injection, and others for people with chemotherapy induced nausea and vomiting. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFosrolapitant and Palonosetron Hydrochloride for Injection

On the first day of chemotherapy, a 60-minute intravenous infusion is administered prior to treatment

DRUGDexamethasone

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

DRUGOlanzapine

From the first day of chemotherapy until three days after its completion, take 5mg orally each night before bedtime


Locations(1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

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NCT07482891


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