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Recruiting NCT07381634

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

Phase II Interventional Hepatocellular Carcinoma (HCC) IrAE

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ondansetron.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC), IrAE. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug ondansetron
    Ondansetron: Maintained at 8mg/qd, orally, until disease progression or intolerance.

Primary outcome measures

  • The incidence rate of irAEs [Time frame: through study completion, an average of 1 year]
  • The Severity of irAEs [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
  • ORR [Time frame: through study completion, an average of 1 year]
  • DCR [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT07381634 · KY2026-021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗