Hepatocellular carcinoma
Conditions
Interventions
Trial Group:Ondansetron 8mg/qd oral, combined with standard ICI treatment regimen (Lenvatinib + Tislelizumab or Lenvatinib + Pembrolizumab or Atezolizumab + Bevacizumab)
Control Group:Standard ICI treatment regimen (Lenvatinib + Tislelizumab or Lenvatinib + Pembrolizumab or Atezolizumab + Bevacizumab), without Ondansetron
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 years old - 80 years old, both genders are eligible; 2. Diagnosed with hepatocellular carcinoma through imaging or pathological examination; 3. Plan to undergo standard treatment for liver cancer: lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab; 4. ECOG score: 0 - 2; 5. Expected survival period: >= 12 weeks; 6. Baseline blood cell count tests and blood biochemical tests must meet the following standards: (1) White blood cell count >= 3.0×10^9/L; (2) Hemoglobin >= 90 g/L; (3) Absolute neutrophil count >= 1.5×10^9/L; (4) Platelet count >= 100×10^9/L; (5) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 30 g/L; 7. Participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have used ondansetron or other 5-HT3 receptor antagonists within 14 days; 2. Patients with immune diseases; 3. Those who have used systemic glucocorticoids or other immunosuppressants within 14 days; 4. Those who have discontinued ICI treatment due to irAEs in the past; 5. Patients with severe liver dysfunction (Child-Pugh C grade); 6. Those with ondansetron contraindications such as serotonin syndrome or phenylketonuria; 7. Patients who are allergic to ondansetron; 8. Those who are using drugs that may have severe interactions with ondansetron, such as apomorphine; 9. Patients who, according to the investigator's assessment, cannot or are unwilling to comply with the requirements of the study protocol.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate (ORR, DCR); | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of immune-related adverse events; | — |
Countries
China
Contacts
Public ContactChen Gang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed