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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Fosrolapitant 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.
Fosapirtan 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.
SAHZhejiangU
Hangzhou, Zhejiang, China
RECRUITINGThe 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;
Time frame: The super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle,each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
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;
Time frame: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
The time of the first vomiting
The time of the first vomiting was compared through the Kaplan-Meier curv
Time frame: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
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)
Time frame: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
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