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;
Abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy was received within 7 days prior to randomization, or is planned to be received within 1 to 8 days of treatment;
It is planned to administer chemotherapy drugs with a high risk of vomiting within 2 to 8 days after platinum infusion.
Plan to receive chemotherapy regimens including common paclitaxel (using castor oil as the solvent);
Take drugs with potential antiemetic effects within 2 days before randomization: The first-generation 5-HT3 receptor antagonists (such as ondansetron), phenthiazide drugs (such as prochlorazine), butanylbenzene drugs (such as haloperidol), benzamides (such as metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, cyclezine, etc.
Parallel
Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate
DrugFosrolapitant and Palonosetron Hydrochloride for Injection: Intravenous drip for 1 hour (+10 minutes), once before each cycle of chemotherapy. Dexamethasone acetate: Take 12mg orally on the first day of each chemotherapy cycle before chemotherapy, and 3.75mg orally on the second to fourth days twice a day.
For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate
DrugFosapirtan dimeglumine for injection: 150mg, intravenous drip for 20-30 minutes, administered once before each cycle of chemotherapy. Palonosetron hydrochloride: 0.25mg, intravenous injection for at least 30 seconds, administered once before each cycle of chemotherapy. Dexamethasone acetate: Take 6mg orally on the first day of each chemotherapy cycle before chemotherapy, 3.75mg orally once on the second day, and 3.75mg orally every day from the third to the fourth day.
The proportion of subjects who achieved complete remission (CR: no vomiting and remedial treatment) in the super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle;
The CR rate in the acute phase (0 hour-24 hour), delayed phase (24 hour-120 hour), overall phase (0 hour-120 hour), and 0 hour-168 hour of each immunotherapy combined with chemotherapy cycle;
The time of the first vomiting
The time of the first vomiting was compared through the Kaplan-Meier curv
The impact of chemotherapy-induced nausea and vomiting (CINV) on quality of life
The impact of chemotherapy-induced nausea and vomiting (CINV) on quality of life was evaluated by functional life Index - Vomiting (FLIE)
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