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

Wenzhou Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: IrAE; Hepatocellular Carcinoma (HCC)

Treatments: Drug: ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT07381634

KY2026-021

Details and patient eligibility

About

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 66 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Ondansetron Group

Experimental group

Description:

Standard treatment plan：For patients with hepatocellular carcinoma, the standard treatment plan for liver cancer is adopted, which specifically includes lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab: Ondansetron: Maintained at 8mg/qd, orally, until disease progression or intolerance. Symptomatic treatments other than 5-HT3 receptor antagonists are permitted, and all concurrent medication situations should be recorded.

Treatment:

Drug: ondansetron

Control Group

No Intervention group

Description:

Standard treatment plan：For patients with hepatocellular carcinoma, the standard treatment plan for liver cancer is adopted, which specifically includes lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab Symptomatic treatments other than 5-HT3 receptor antagonists are permitted, and all concurrent medication situations should be recorded.