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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • ondansetron

Treatment groups

134 Participants
are divided into 2 treatment groups

Locations

This trial has no locations