Adjuvant Tislelizumab With or Without Lenvatinib for Patients at High-risk of Hepatocellular Carcinoma Recurrence After Curative Resection or Ablation: a Multicentric, Prospective Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recurrene-free survival
研究概览
简要总结
Though hepatic resection and ablation are the curative treatments for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced or unresectable HCC. No study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy is reported.
详细描述
Hepatic resection and ablation are the best treatments for patients with early stage hepatocellular carcinoma (HCC) or selected intermediate or advanced disease. However, the postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause of death. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC by official guidelines. At the same time, four randomizead controlled trials about adjvuant immune checkpoint inhibitors for postoperative HCC are ongoing. A prospective cohort study found adjuvant immune checkpoint inhibitors with or without tyrosine kinase inhibitors may improve recurrence-free survival of patients at high-risk of HCC recurrence after curative resection (DOI: 10.1200/JCO.2023.41.16_suppl.4119. Journal of Clinical Oncology 41, no. 16_suppl. 4119). Therefore, the investigators plan to compare the safety and efficacy of adjuvant Tislelizumab plus lenvatinib to Tislelizumab monotherapy for patients with high-risk factor of HCC recurrence after curative resection and ablation in a multicentric, prospective study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years (inclusive);
- •Diagnosis of HCC confirmed by postoperative histopathology;
- •Underwent curative resection, as defined based on intra- and postoperative criteria;
- •With high-risk factors of recurrence after curative treatment, based on preoperative radiological imaging or pathology reports indicating a tumor at least 5 cm in diameter, micro- or macrovascular invasion (Vp1/Vp2), satellite or multinodular tumors, and/or Grade 3/4 pathology;
- •No residual cancer detected by radiological imaging in the liver within 8 weeks after curative resection;
- •Child-Pugh 5-7 scores liver function;
- •Eastern Cooperative Oncology Group performance status of 0 or 1.
排除标准
- •Received neoadjuvant immune checkpoint inhibitors or tyrosine kinase inhibitors before resection or ablation;
- •A history of other malignancies;
- •History of active autoimmune or immunodeficiency diseases;
- •Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;
- •Loss to follow-up within six months.
研究组 & 干预措施
Adjuvant tislelizumab plus lenvatinib
Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab plus lenvatinib treatment for six months, HCC recurrence, or unacceptable adverse events.
干预措施: Adjuvant tislelizumab plus lenvatinib (Drug)
Adjuvant tislelizumab
Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab treatment for six months, HCC recurrence, or unacceptable adverse events.
干预措施: Adjuvant tislelizumab (Drug)
结局指标
主要结局
Recurrene-free survival
时间窗: 3 years
Recurrene-free survival will be calculated using the Kaplan-Meier method, and differences between groups are assessed for significance using the log-rank test.
次要结局
- Overall survival(3 years)
- Adverse events(1 years)
研究者
Jian-Hong Zhong
Principal Investigator
Guangxi Medical University