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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
Epirubicin is a chemotherapy drug used in TACE
lipiodol is a kind of embolization material used in TACE
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
Early recurrence rates
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
Time frame: 1 year after hepatectomy
Overall Survival
OS was defined as the interval from date of HCC resection to death due to any cause.
Time frame: up to 3 years
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Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China