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NOT YET RECRUITING
NCT07482891
PHASE4

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

Sponsor: Shanghai 6th People's Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-03-10

Completion Date

2026-12-31

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

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