TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.
详细描述
For patients with hepatocellular carcinoma staged BCLC B/C(intermediate hepatocellular carcinoma)，TACE is a widely used treatments .However ,The efficacy of TACE in intermediate hepatocellular carcinoma is not very satisfactory.A series of study demonstrated that direct hepatectomy has better prognosis compared with TACE for these intermediate hepatocellular carcinoma patients.Despite of this ,The high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver .In addition, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.In this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of TACE/HAIC combined with PD-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 18-70 years old, gender is not limited.
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- •Patients must have at least one tumor lesion that can be accurately measured.
- •Conform to any of the following criteria (1) multiple nodules >3; (2) ≥2 nodules, any of which is >3 cm; (3) invasion of the portal vein or hepatic vein.
- •According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group
- •No previous anti-HCC treatment.
- •Eastern Co-operative Group performance status 2 or less.
- •Liver function: Child's A or B (score < 7).
排除标准
- •Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava;
- •Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs;
- •Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months
研究组 & 干预措施
Direct surgery group
After being diagnosed with hepatocellular carcinoma, surgery will be immediately performed.
干预措施: liver resection (Procedure)
TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection
干预措施: TACE/HAIC (Procedure)
TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection
干预措施: Lenvatinib (Drug)
TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection
干预措施: Sintilimab (Drug)
结局指标
主要结局
Recurrence-free Survival
时间窗: 12 months
Time from the start of liver resection until tumor recurrence or death (from any cause).
次要结局
- Adverse effects(12 months)
研究者
Zhang Yingcai
doctorate
Third Affiliated Hospital, Sun Yat-Sen University