Adjuvant Sintilimab Plus Lenvatinib for HCC Characterized With VETC Following Liver Resection: A Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 234
- 主要终点
- Disease-free survival
研究概览
简要总结
Vessels that encapsulate tumor clusters (VETC) are a novel invasive metastatic factor in hepatocellular carcinoma (HCC), operating independently of the epithelial-mesenchyme transition (EMT). The presence of VETC is associated with a higher rate of postoperative recurrence in HCC patients, indicating a more aggressive biological behavior.Improving the prognosis for VETC-positive patients is a critical issue in clinical oncology.
详细描述
Previous studies have established that VETC is a novel mode of metastasis, independent of EMT, and may be associated with immune suppression and poor prognosis. Numerous retrospective studies have found that patients with VETC positivity have higher rates of postoperative recurrence and distant metastasis. How to improve the surgical prognosis for VETC-positive patients remains to be explored. Currently, there are no published studies on how to improve the prognosis for this group of individuals. One of our unpublished retrospective studies found that treatment with PD-1 monoclonal antibodies does not effectively improve the prognosis for VETC-positive patients. However, the combination of PD-1 monoclonal antibodies with lenvatinib can effectively reduce postoperative recurrence and improve prognosis in VETC-positive patients. Therefore, we have designed this multicenter, randomized controlled trial to explore the efficacy and safety of lenvatinib in combination with sintilimab in VETC-positive HCC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years;
- •No previous local or systemic treatment for hepatocellular carcinoma;
- •Child-Pugh liver function score ≤ 7; ④ECOG PS 0-1; ⑤BCLC stage 0-C, underwent R0 resection and confirmed by pathology as hepatocellular carcinoma; ⑥No major systemic diseases, immunodeficiency diseases, etc.; ⑦CD34 immunohistochemical staining confirms the presence of VETC in the intratumoral vascular pattern (part or all of the field of view)
排除标准
- •Pregnant or breastfeeding women;
- •Recurrent HCC, distant metastasis or other systemic tumors;
- •Vascular invasion involving the mesenteric vein, main portal vein, hepatic vein or inferior vena cava;
- •History of gastrointestinal bleeding within the past 4 weeks;
- •Active infection; ⑥Other significant clinical and laboratory abnormalities that affect safety evaluation; ⑦Inability to follow the study protocol, receive treatment or follow-up as scheduled
研究组 & 干预措施
Adjuvant group
Patients in the adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.
干预措施: Sintilimab (Drug)
Adjuvant group
Patients in the adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.
干预措施: 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
DFS defined as time to recurrence or death after surgery.
次要结局
- Overall survival(From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months)
- Adverse events(Baseline up to 60 months)
研究者
Wan-Guang Zhang
Professor
Tongji Hospital