NCT07482891

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Fosrolapitant and Palonosetron Hydrochloride for Injection	On the first day of chemotherapy, a 60-minute intravenous infusion is administered prior to treatment
DRUG	Dexamethasone	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
DRUG	Olanzapine	From the first day of chemotherapy until three days after its completion, take 5mg orally each night before bedtime

Timeline

• Start date: 2026-03-10
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2026-03-19
• Last updated: 2026-03-19