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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
Tianjin Cancer Hospital Airport Hospital
Tianjin, China
RECRUITINGOverall Complete Response (CR) Rate
The proportion of participants without any vomiting episodes and without receiving rescue antiemetic medication during the overall 0-120 hour period after trastuzumab rezetecan infusion.
Time frame: 0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Acute Phase (0-24 h)
Percentage of participants with no vomiting and no rescue antiemetics within 0-24 hours post trastuzumab rezetecan
Time frame: 0 to 24 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Delayed Phase (24-120 h)
Percentage of participants with no vomiting and no rescue antiemetics within 24-120 hours post trastuzumab rezetecan
Time frame: 24 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Very Delayed Phase (120-168 h)
Percentage of participants with no vomiting and no rescue antiemetics within 120-168 hours post trastuzumab rezetecan
Time frame: 120 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Protection (CP) Rate
Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score \<25 mm during observation period
Time frame: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Control (TC) Rate
Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score \<5 mm during observation period
Time frame: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
No Nausea Rate & No Vomiting Rate & No Rescue Medication Rate
No nausea rate: participants with maximum VAS nausea score \<5 mm; No vomiting rate: participants with zero vomiting episodes (rescue use allowed); No rescue medication rate: participants who never use rescue antiemetics
Time frame: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Rate of Trastuzumab Rezetecan Dose Delay or Reduction Due to Nausea and Vomiting
Percentage of subjects whose trastuzumab rezetecan dose is delayed or reduced caused by treatment-induced nausea and vomiting
Time frame: ntire duration of Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Safety Endpoints (Adverse Events, Serious Adverse Events)
Incidence, severity (graded per CTCAE v5.0) and relatedness of all adverse events (AEs), treatment-related AEs, ≥3 grade AEs and serious adverse events (SAEs); changes in vital signs and laboratory parameters
Time frame: From informed consent signing to 30 days after last study drug administration
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