Effectiveness of Triple Versus Dual Adjuvant Therapy in VETC-positive Population Following Liver Resection for HCC: 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
- DFS
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. What can be done to improve the surgical prognosis of this group of patients needs to be continuously explored.
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. 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. There are no published studies on how to improve prognosis for VETC-positive 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 One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis, however, PD-1 inhibitor combined with lenvatinib reduces recurrences significantly. In addition, some studies have also found that postoperative adjuvant hepatic artery infusion chemotherapy (HAIC) is also potentially useful in improving surgical prognosis. It is not clear whether triple therapy can further reduce recurrence in these tumors, which have highly aggressive characteristics.
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
Triple adjuvant therapy group
Patients in the triple adjuvant therapy group received HAIC in combination with PD-1 inhibitors and lenvatinib adjuvant therapy.
干预措施: HAIC plus PD-1 inhibitors plus lenvatinib (Drug)
Dual adjuvant therapy group
Patients in the Dual adjuvant therapy group received PD-1 inhibitors combined lenvatinib adjuvant therapy.
干预措施: PD-1 inhibitors plus lenvatinib (Drug)
结局指标
主要结局
DFS
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
- OS(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