The Efficacy and Safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in Preventing Nausea and Vomiting Caused by Multi-cycle Immunotherapy and Chemotherapy in Patients With Esophageal Cancer and Lung Cancer
This study was a randomized, parallel, cohort study to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting caused by multi-cycle immunotherapy and chemotherapy in patients with esophageal cancer and lung cancer. A total of 120 subjects are planned to be enrolled, with 60 in each cohort. 40% of the subjects will undergo an interim analysis upon completion of the study. The trial consists of a screening period, a treatment period and a safety follow-up period. Drug treatment was administered in accordance with the trial protocol, and then the corresponding follow-up and examination were completed in accordance with the trial process table. During the research period, if the researcher assesses that the subjects indeed need to use remedial antiemetic drugs, remedial treatment can be carried out based on clinical practice. The specific types, usage, dosage and frequency of the drugs are determined by the researcher.
• Age ≥18 years old, gender not limited;
• Histologically or cytologically confirmed untreated locally advanced/metastatic esophageal cancer and lung cancer;
• Has not received any chemotherapy drugs in the past (anti-tumor drugs are not used for cancer treatment);
• Plan to receive at least 4 cycles of chemotherapy combined with immunotherapy based on cisplatin and carboplatin;
• Expected survival period ≥3 months;
• Eastern Cooperative Oncology Group (ECOG) Physical Condition score: 0 or 1 point;
• Good organ function, meeting the following criteria:
‣ Neutrophil count ≥1.5×109/L;
⁃ Hemoglobin ≥ 90g/L;
⁃ Platelet count ≥ 100×109/L;
⁃ Total bilirubin ≤1.5×ULN In patients without known liver metastases, aspartate aminotransferase ≤2.5×ULN and/or alanine aminotransferase ≤2.5×ULN (for patients with liver metastases, it can be relaxed to ≤5×ULN);
• f: Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥ 50ml/min; g: Electrocardiogram: QTc≤450ms (for males), QTc≤470ms (for females); h: Cardiac color Doppler ultrasound: LVEF (left ventricular ejection fraction) ≥50%;
• Fertile female subjects and male subjects whose partners are fertile women need to adopt an effective contraceptive measure from the time of signing the informed consent form until 6 months after the last administration. Female subjects with fertility must have a negative blood pregnancy test within 72 hours before randomization. And it must be non-lactation period;
• Clearly understand and voluntarily participate in this research, and sign the informed consent form by oneself.