VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 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. How to improve the prognosis of this group of patients is an urgent issue to be addressed.
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 are no published studies on how to improve prognosis for this population. One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis. However, PD-1 monoclonal antibody in combination with PD-1 monoclonal antibody effectively reduced postoperative recurrence and improved prognosis in VETC-positive patients. Based on our previous retrospective data, this multicenter prospective cohort study was designed to further validate and explore effective therapeutics.
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
- •No previous local or systemic treatment for hepatocellular carcinoma.
- •Child-Pugh liver function score ≤
- •No serious organic diseases of the heart, lungs, brain, kidneys, etc.
- •Pathologic type is hepatocellular carcinoma.
- •Confirmation of the presence of VETC vascular pattern by CD34 immunohistochemical staining.
排除标准
- •Pregnant and lactating women.
- •Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
- •A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
- •Active infection.
- •Other significant clinical and laboratory abnormalities that affect the safety evaluation.
- •Inability to follow the study protocol for treatment or follow up as scheduled.
研究组 & 干预措施
Combined adjuvant therapy group
Patients in the combined adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.
干预措施: PD-1 monoclonal antibody and lenvatinib (Drug)
Monotherapy group
Patients in the monotherapy group received PD-1 monotherapy after liver resection.
干预措施: PD-1 monoclonal antibody (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)
研究者
Chen Xiaoping
Professor
Tongji Hospital