Ondansetron to reduce immune‑therapy–related toxicities in liver cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, single‑center phase 2 trial enrolling about 134 adults with hepatocellular carcinoma. Participants will receive standard ICI-based treatment (lenvatinib plus tislelizumab, lenvatinib plus pembrolizumab, or atezolizumab plus bevacizumab) and will be randomized to receive ondansetron as a potential modifier of treatment toxicity. The study uses the 2023 CSCO guidelines to assess irAEs and compares incidence and severity between groups. Primary endpoints focus on safety and reduction of immune‑related adverse events, with toxicity monitoring as a key outcome. The trial is conducted at the First Affiliated Hospital of Wenzhou Medical University and is sponsored by that institution.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.