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.
Inclusion Criteria:
Sign a written informed consent form and voluntarily enroll in this study;
Be at least 18 years of age; gender is not a restriction;
Be a patient scheduled to receive treatment with Trastuzumab Rezetecan;
Have an ECOG performance status score of 0-2;
No ascites or pleural effusion requiring drainage;
No gastrointestinal obstruction, such as pyloric stenosis or intestinal obstruction;
Expected survival of ≥12 weeks;
Good organ and bone marrow function, defined as follows:
Hematologic System (No blood transfusions or treatment with hematopoietic growth factors within the past 14 days)
Agree to cooperate in completing daily nausea and vomiting logs and scale assessments;
Understand the nature of this study; the patient and/or legal guardian voluntarily agree to participate in this trial and sign the informed consent form.
Exclusion Criteria:
zhjiang@tmu.edu.cn
All subjects who meet the inclusion criteria will receive prophylactic antiemetic treatment with Fosrolapitant and Palonosetron Hydrochloride to receiving an infusion of Trastuzumab Rezetecan. During follow-up, investigators will collect data on nausea, vomiting, use of rescue medication, and adverse events to evaluate the efficacy and safety of this hormone-free antiemetic regimen.
Neoadjuvant SHR-A1811 and SHR-A1701 ± Pertuzumab for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma
Neoadjuvant SHR-A1811 and SHR-A1701 for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma
Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Trastuzumab Deruxtecan
Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer
Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
A Phase II Exploratory Study of Iparomlimab and Tuvonralimab Combined With Chemotherapy in Neoadjuvant Treatment of HR+/HER2- Breast Cancer Patients