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NCT07381634RecruitingPhase 2

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

The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities: A Single-Center Randomized Controlled Clinical Trial

Source: ClinicalTrials.gov · Last updated 4 Aug 2026

Brief summary (registry, in English)

This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
134 (estimated)
First submitted
3 Jan 2026
Start date
30 Apr 2026
Primary completion date
20 Dec 2026
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
NCT number
NCT07381634

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 134
  • From 30 Apr 2026 to the primary completion date, 20 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those who have received treatment with ondansetron within 14 days;
  • Those who have previously discontinued ICI treatment due to irAEs;
  • Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;

Other illness

  • Patients with autoimmune diseases;
  • Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;
  • Patients allergic to ondansetron;

Other

  • Use of systemic glucocorticoids or other immunosuppressants within 14 days;
  • Those with severe liver dysfunction (Child-Pugh grade C);
  • The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
First Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.