Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07381634
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 to 80 years old, both male and female are acceptable.
2. The imaging or pathological diagnosis is hepatocellular carcinoma;
3. It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab.
4. ECOG score: 0 to 2 points;
5. Expected survival period ≥12 weeks;
6. 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;
7. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion Criteria:
1. Those who have received treatment with ondansetron within 14 days;
2. Patients with autoimmune diseases;
3. Use of systemic glucocorticoids or other immunosuppressants within 14 days;
4. Those who have previously discontinued ICI treatment due to irAEs;
5. Those with severe liver dysfunction (Child-Pugh grade C);
6. Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;
7. Patients allergic to ondansetron;
8. Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;
9. The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07381634
Study Brief:
Protocol Section:
NCT07381634