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.
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;
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;
Parallel
ondansetron
DrugOndansetron: Maintained at 8mg/qd, orally, until disease progression or intolerance.
The incidence rate of irAEs
To evaluate whether the prophylactic use of ondansetron can reduce the incidence of immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitors (ICI). The evaluation criteria mainly refer to the "2023 CSCO Guidelines for the Management of Toxicity Related to Immune Checkpoint Inhibitors", with a focus on the incidence of all grades of irAEs and the incidence of severe irAEs at grade 3 and above. The monitoring scope covers liver and kidney functions, blood routine, cardiac function (electrocardiogram, myocardial injury markers), endocrine function (thyroid function, etc.) and imaging manifestations of pneumonia.
The Severity of irAEs
To evaluate whether the prophylactic use of ondansetron can reduce the severity of immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitors (ICI). The evaluation criteria mainly refer to the "2023 CSCO Guidelines for the Management of Toxicity Related to Immune Checkpoint Inhibitors", with a focus on the incidence of all grades of irAEs and the incidence of severe irAEs at grade 3 and above. The monitoring scope covers liver and kidney functions, blood routine, cardiac function (electrocardiogram, myocardial injury markers), endocrine function (thyroid function, etc.) and imaging manifestations of pneumonia.
ORR
Objective Response Rate，according to RECIST v1.1
DCR
Disease Control Rate, according to RECIST v1.1
Click on the lead sponsor to view all of their trials.
