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NOT YET RECRUITING
NCT07381634
PHASE2

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

Sponsor: First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2026-03-20

Completion Date

2027-06-20

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

ondansetron

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