Aprepitant Plus Granisetron and Dexamethasone for the Prevention of Vomiting in Patients With HAIC Therapy for HCC

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the safety and efficacy of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in the prevention of nausea and vomiting in patients with hepatocellular carcinoma (HCC) receiving hepatic arterial infusion chemotherapy (HAIC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangxi Medical University
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone acetate; Granisetron

Criteria

Inclusion Criteria:

• Age: 18-75 years old;

• The patient is diagnosed with hepatocellular carcinoma according to the clinical diagnostic criteria of the Guideline for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) issued by the Health Commission of the People's Republic of China or confirmed by histopathology;

• ECOG performance score 0 or 1;

• Child-Pugh score of 5-7 (liver function);

• Receiving hepatic arterial infusion chemotherapy treatment;

• Expected survival time ≥6 months;

• Hematological indexes should meet the following conditions: hemoglobin ≥90 g/L; Absolute neutrophil count ≥1.5×10^9/L; Platelet ≥75×10^9/L; Total bilirubin ≤1.5×ULN; ALT≤3×ULN; AST≤3 x ULN; Alkaline phosphatase (AKP) ≤2.5×ULN; Serum albumin ≥28 g/L; Serum creatinine ≤1.5×ULN;

• Urine protein <2+ or 24h urine protein quantity < 1.0g;

• For women of childbearing age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) are required during the clinical trial until 120 days after the end of the clinical trial; Women of childbearing age had negative serum or urine HCG test results within 7 days prior to study inclusion; Male patients with fertile partners should use effective contraception during the study period and for 120 days after the study ends.

Exclusion Criteria:

• Received systematic chemotherapy in the past;

• The presence of congenital or acquired immunodeficiency diseases (such as HIV positive);

• Active infection, or body temperature ≥ 38.5℃ or white blood cell count > 15 x 10^9/L 7 days before enrollment;

• Complications of arterial or venous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary infarction, etc. within 6 months;

• Those who have a history of alcohol or psychotropic drug abuse and cannot quit or have mental disorders;

• Pregnant or lactating women;

• being treated with immunosuppressants or glucocorticoids (>10mg prednisone equal dose per day) within 2 weeks;

• Previous history of motion sickness, or combined with hepatic encephalopathy or brain metastases;

• Uncontrolled heart disease or symptoms (including but not limited to grade II or above heart function, unstable angina, myocardial infarction in the past 1 year, supraventricular or ventricular arrhythmias requiring treatment or intervention)