Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Recurrence-free survival （RFS）
研究概览
简要总结
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. The high risk of recurrence after surgery is another challenge for surgeons. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.
详细描述
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. However, the 2-year recurrence rate in such cases is as high as 70%, indicating the need for more effective interventions to improve outcomes. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The impact of neoadjuvant TACE on the long-term oncological outcomes of huge HCC requires investigation. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.
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
- •clinical or pathological diagnosis of primary HCC;
- •tumor diameter > 10 cm on images before inclusion;
- •age 18 to 75 years;
- •no macrovascular invasion or extrahepatic metastasis;
- •liver resection with complete removal of the tumor and adequate remnant liver volume;
- •albumin-bilirubin (ALBI) grade I and II;
- •Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
- •hemoglobin level ≥ 8.5 g/dL, total bilirubin level ≤ 30 mmol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) levels ≤ 5 × upper limit of normal, serum creatinine level ≤ 1.5 × upper limit of normal;
- •prothrombin time ≤ 18 s or international normalized ratio < 1.7.
排除标准
- •HCC with macrovascular invasion or extrahepatic metastasis;
- •tumor with a maximum diameter ≤ 10 cm on images before inclusion;
- •recurrent HCC;
- •serious medical comorbidities;
- •portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
- •cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
- •incomplete data or lost to follow-up within three months.
结局指标
主要结局
Recurrence-free survival （RFS）
时间窗: 24 months
RFS was defined as the time from surgery to tumor progression or the last follow-up
次要结局
- Overall survival (OS)(60 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University