The Efficacy and Safety of Adjuvant TACE in Radical Surgery for Hepatocellular Carcinoma With High-risk Recurrence Factors: A Phase III Randomized Controlled Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
The 5-year recurrence rate after curative hepatectomy of hepatocellular carcinoma (HCC) remains as high as 70%. According to the Chinese Liver Cancer Staging (CNLC), transarterial chemoembolization (TACE) is strongly recommended as an adjuvant therapy after curative hepatectomy, aiming to reduce postoperative recurrence and ultimately improve overall survival. However, the effectiveness of such adjuvant postoperative therapy remains controversial. In contrast, guidelines from other countries or regions do not recommend adjuvant TACE after curative hepatectomy. This discrepancy may stem from the fact that adjuvant TACE primarily serves to detect intrahepatic residual lesions via digital subtraction angiography, rather than exerting preventive or therapeutic effects through the embolic agents or chemotherapeutic drugs themselves. This study will evaluate the impact of adjuvant TACE on recurrence-free survival in HCC patients with high-risk recurrence factors who have undergone curative hepatectomy. This study is a Phase III randomized controlled trial in which a total of 442 eligible participants will be randomized in a 1:1 ratio to either the adjuvant TACE group or the intensive follow-up group. The two groups will be compared with respect to recurrence-free survival, overall survival, incidence of treatment-related adverse events and serious adverse events, incidence of treatment discontinuation due to treatment-related adverse events or serious adverse events, median recurrence-free survival, and time to recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 at enrollment;
- •Child-Pugh class A or B7 (score 5-7);
- •having undergone radical hepatic resection at one of the study centers;
- •histopathologically confirmed HCC;
- •undergo hepatic angiography 4-8 weeks after surgery, with confirmation of no intrahepatic tumor staining;
- •have no prior systemic anti-tumor therapy for HCC;
- •have adequate organ and bone marrow function;
- •estimated life expectancy >6 months;
- •present with at least one high-risk factor for recurrence (such as tumor rupture; maximum tumor diameter >5 cm; multifocal tumors; microvascular invasion on postoperative pathology; Vp1/Vp2 portal vein invasion; lymph node metastasis confirmed by postoperative pathology; positive or narrow surgical margin; and Edmondson grade Ⅲ-Ⅳ differentiation).
排除标准
- •absence of pathological confirmation of HCC;
- •diagnosis of other malignancies within the 5 years prior to enrollment;
- •a history of hepatic encephalopathy, liver transplantation, pleural effusion, ascites, or pericardial effusion with clinical symptoms after curative hepatectomy, as well as a history of drug allergy, active pulmonary tuberculosis, active syphilis infection, autoimmune disease, or long-term glucocorticoid use;
- •participants who have experienced severe infections within 4 weeks before the first dose, or who have previously received systemic anti-tumor therapy;
- •pregnant or lactating women are ineligible for participation;
- •participants who are unable to comply with the treatment regimen or complete the follow-up requirements.
研究组 & 干预措施
Adjuvant transarterial chemoembolization
For patients in the adjuvant TACE group, after superselective catheterization near the hepatic resection margin, embolization will be performed using an emulsion of 50 mg lobaplatin and 3-5 mL ethiodized poppyseed oil. This chemotherapeutic regimen is adopted from previous RCTs that showed adjuvant TACE significantly reduces postoperative HCC recurrence. The use of polyvinyl alcohol embolic microspheres is not part of the standard adjuvant TACE protocol. In the intensive follow-up group, hepatic arteriography will be performed without subsequent administration of embolic agents or chemotherapeutic drugs. Post-procedure, the catheter and arterial sheath will be removed, with compression applied to the puncture site for hemostasis. The intervention group will receive adjuvant TACE only once.
干预措施: Adjuvant transarterial chemoembolization (Drug)
Intensive follow-up
The patients will receive intensive follow-up.
干预措施: Intensive follow-up (Other)
结局指标
主要结局
Recurrence-free survival
时间窗: two years
The primary outcome is RFS, defined as the time from the date of randomization to the first occurrence of HCC recurrence, as identified by imaging.
次要结局
未报告次要终点
研究者
Jian-Hong Zhong
Professor
Cancer Hospital of Guangxi Medical University