The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities (NCT07381634) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities
134 participantsStarted 2026-03-20
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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:
✓. 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;
✕
What they're measuring
1
The incidence rate of irAEs
Timeframe: through study completion, an average of 1 year
2
The Severity of irAEs
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT07381634
SponsorFirst Affiliated Hospital of Wenzhou Medical University