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RECRUITING
NCT07726433
PHASE2

Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with recanituzumab. All patients who meet the inclusion criteria and do not meet any exclusion criteria are eligible for enrollment in this study and are scheduled to receive targeted therapy, antiemetic treatment, and follow-up. Dosage Regimen Eligible subjects will receive a prophylactic antiemetic regimen consisting of foslorapitant and palonosetron. The dosage regimen is as follows: Day 1 (D1): Foslorapitant and palonosetron (218 mg foslorapitant and 0.25 mg palonosetron hydrochloride), administered intravenously (IV) 1 hour prior to chemotherapy. Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.

Official title: A Multicenter, Exploratory Clinical Study of the Efficacy and Safety of Phentolamine and Palonosetron for the Prevention of Nausea and Vomiting Associated With Recom-Trastuzumab Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-06-15

Completion Date

2028-06-01

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DRUG

Fosrolapitant and Palonosetron Hydrochloride for Injection

D1: Fosrolapitant and Palonosetron Hydrochloride for Injection (218 mg of pholorapitant and 0.25 mg of palonosetron hydrochloride), IV, administered 1 hour before chemotherapy. Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.

Locations (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, China