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.
Aged 18-75 years, any gender, voluntarily signed informed consent form (ICF), with good compliance;
Histologically or cytologically confirmed malignant solid tumour;
No prior exposure to any chemotherapeutic agents;
First-time participants with malignant solid tumours scheduled to receive a treatment regimen based on multi-day HEC chemotherapy (HEC refers to the risk of anti-tumour drug-induced nausea and vomiting as defined in the 2023 Edition of the Chinese Guidelines for the Prevention and Treatment of Nausea and Vomiting Associated with Anti-tumour Therapy; 'multi-day' denotes each chemotherapy cycle lasting at least 3 days);
Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
Subjects who have received radiotherapy within 7 days prior to enrolment, extensive radiotherapy (e.g., whole-chest or whole-abdomen radiotherapy) within 3 months prior to enrolment, local palliative radiotherapy (e.g., for bone or lymph node metastases) within 1 month prior to enrolment, or who are scheduled to undergo any radiotherapy during the study period;
Administration within 2 days prior to enrolment of medications with potential antiemetic effects: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, or secloperazine;
Initiation of benzodiazepine or opioid therapy within 2 days prior to enrolment (excluding zolpidem, temazepam, or midazolam administered alone daily);
Parallel
Fosrolapitant and Palonosetron Hydrochloride for Injection
DrugOn the first day of chemotherapy, a 60-minute intravenous infusion is administered prior to treatment
Dexamethasone
DrugOn 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
Olanzapine
DrugFrom the first day of chemotherapy until three days after its completion, take 5mg orally each night before bedtime
Percentage of patients achieving Complete Control of CINV from the first administration until 24 hours after the last administration of chemotherapy
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) from the first administration until 24 hours after the last administration of chemotherapy
Percentage of patients achieving Complete Control of CINV during the acute phase, delayed phase, and super-delayed phase
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
No significant nausea
To compare the proportion of subjects with no significant nausea (defined as maximum nausea on a visual analogue scale \<25 mm) during the specified period.
No nausea
To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale \<5 mm) during the specified period.
No emetic
To compare the proportion of subjects with no emetic event during the specified period
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