The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities: A Single-Center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- The incidence rate of irAEs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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;
- •The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
排除标准
- •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;
- •Those with severe liver dysfunction (Child-Pugh grade C);
- •Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;
- •Patients allergic to ondansetron;
- •Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;
- •The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.
研究组 & 干预措施
Ondansetron Group
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.
干预措施: ondansetron (Drug)
Control Group
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.
结局指标
主要结局
The incidence rate of irAEs
时间窗: through study completion, an average of 1 year
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
时间窗: through study completion, an average of 1 year
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.
次要结局
- ORR(through study completion, an average of 1 year)
- DCR(through study completion, an average of 1 year)
研究者
Gang Chen, MD
Director of Hepatobiliary Surgery, Clinical Professor, Vice President
First Affiliated Hospital of Wenzhou Medical University