NCT07381634 The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities
| NCT ID | NCT07381634 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 134 participants in total. It began in 2026-04-30 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07381634 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07381634 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07381634 currently recruiting?
Yes, NCT07381634 is actively recruiting participants. Visit ClinicalTrials.gov or contact First Affiliated Hospital of Wenzhou Medical University to inquire about joining.
Where is the NCT07381634 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT07381634 clinical trial?
NCT07381634 is sponsored by First Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 134 participants.
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