The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities

Inclusion criteria

• Age: 18 to 80 years old, both male and female are acceptable.
• The imaging or pathological diagnosis is hepatocellular carcinoma;
• It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab.
• ECOG score: 0 to 2 points;
• Expected survival period ≥12 weeks;
• Baseline blood cell count tests and blood biochemistry must meet the following standards:

White blood cell count ≥3.0×10^9/L; Hemoglobin ≥90 g/L; The absolute neutrophil count is ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin ≤ twice ULN; Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g/L;

• The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion criteria

• Those who have received treatment with ondansetron within 14 days;
• Patients with autoimmune diseases;
• Use of systemic glucocorticoids or other immunosuppressants within 14 days;
• Those who have previously discontinued ICI treatment due to irAEs;
• Those with severe liver dysfunction (Child-Pugh grade C);
• Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;
• Patients allergic to ondansetron;
• Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;
• The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.