Clinical Trial

Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV

Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07726433
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Chemotherapy-Induced Nausea and Vomiting (CINV)
Enrollment 56 participants
Start Date 2026-06-15
Primary Completion 2028-06-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-24