Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China
试验速览
- 阶段
- 4 期
- 入组人数
- 256
- 试验地点
- 6
- 主要终点
- Early recurrence rates
研究概览
简要总结
This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.
详细描述
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, and associated morbidity and mortality rates have escalated in recent years. Despite improvements in surveillance and clinical treatment strategies, the prognosis of HCC remains very poor due to high incidence of recurrence and metastasis. Recent clinical studies have provided evidence that circulating tumor cell (CTC) may directly participate in the metastasis cascade in various types of malignancies. The investigators previous data indicated that HCC patients with preoperative CTC levels ≥2 suffered significantly earlier recurrence (within 1 year) than patients with lower levels. However, the benefits of postoperative adjuvant therapies in preventing early recurrence in patients with preoperative CTC ≥2 remain to be elucidated. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. The investigators design a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy to reduce early recurrence rates in HCC patients with preoperative CTC level ≥2.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC patients received curative hepatectomy with negative resection margin
- •Age from 18 to 75
- •Child-Pugh class A
- •ASA class I to II
- •ECOG performance status Grade 0 or 1
- •Preoperative CTC level ≥2 per 7.5 ml peripheral blood
- •No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy
排除标准
- •Patients diagnosed with other types of malignancies besides HCC
- •Patients receiving concomitant local ablation or previous TACE
- •Main portal vein tumor thrombus extraction during hepatectomy
- •Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors.
- •Presence of extra-hepatic or lymphatic metastasis
- •Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L
- •Renal impairment with creatinine > 200micromol/L
- •Severe concurrent medical illness persisting > 6 weeks after hepatectomy
- •History of other cancer
- •Hepatic artery anomaly making TACE not possible
- •Allergy to 5-Fluorouracil, Epirubicin or lipiodol
- •Pregnant woman
- •Informed consent not available
研究组 & 干预措施
Adjuvant TACE
TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
干预措施: lipiodol (Drug)
Adjuvant TACE
TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
干预措施: TACE (Procedure)
Adjuvant TACE
TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
干预措施: Epirubicin (Drug)
结局指标
主要结局
Early recurrence rates
时间窗: 1 year after hepatectomy
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
次要结局
- Overall Survival(up to 3 years)
研究者
Jia Fan
President of Shanghai Zhongshan Hospital
Fudan University