A Robust Biomarker of Aggressive HCC and the Response for Adjuvant PD-1 Inhibitors or Combined TKIs Following Liver Resection: Vessels That Encapsulate Tumor Clusters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Disease -free survival
研究概览
简要总结
Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. However, it is not clear how the surgical prognosis of VETC-positive patients can be improved.
详细描述
Previous studies have identified VETC as a new metastatic pattern independent of EMT that may be associated with immunosuppression as well as poor prognosis. Multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive patients. How to improve surgical prognosis in VETC-positive patients needs to be explored. There is no consensus on postoperative adjuvant therapy for HCC. In recent years, adjuvant immunotherapy (sintilimab) and adjuvant immunotherapy combined with targeted therapy (T+A) have been shown to be effective in improving the surgical prognosis. Therefore, the investigators retrospectively collected three surgical resection cohorts, the surgical resection alone group, the postoperative adjuvant PD-1 monotherapy group, and the postoperative adjuvant PD-1 monotherapy combined with Lenvatinib group, to compare these postoperative adjuvant therapies in a subgroup of VETC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Underwent radical hepatectomy
- •No preoperative treatment
- •Pathological confirmed HCC
- •High-risk recurrent HCC
- •Not receiving any adjuvant therapy or receiving adjuvant therapy with PD-1 monotherapy or receiving adjuvant therapy with PD-1 monotherapy in combination with Lenvatinib after surgery
排除标准
- •Macrovascular invasion
- •No available wax blocks
- •No complete clinical information
研究组 & 干预措施
Adjuvant PD-1 group
Adjuvant therapy with PD-1 monoclonal antibody after hepatectomy
干预措施: PD-1 monoclonal antibody and lenvatinib (Drug)
Adjuvant PD-1 plus Lenvatinib group
Adjuvant therapy with PD-1 monoclonal antibody combined with lenvatinib after hepatectomy.
干预措施: PD-1 monoclonal antibody and lenvatinib (Drug)
结局指标
主要结局
Disease -free survival
时间窗: From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months
Disease-free survival was defined as defined as the time from enrollment to diagnosis of recurrence or death from any cause.
次要结局
未报告次要终点
研究者
Chen Xiaoping
Professor
Tongji Hospital