Clinical trial NCT02631499: Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation
Official title: Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carcinoma, Hepatocellular
Neoplastic Cells, Circulating
Keywords: Circulating Tumor Cells
Hepatoectomy
TACE
prognosis
relapse
Chemoembolization, Therapeutic
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Johnson & Johnson Medical, China
First posted: 2015-12-16
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Early recurrence rates
timeFrame: 1 year after hepatectomy
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Soochow
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital, Fudan University
name: Jia Fan, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun YF, Xu Y, Yang XR, Guo W, Zhang X, Qiu SJ, Shi RY, Hu B, Zhou J, Fan J. Circulating stem cell-like epithelial cell adhesion molecule-positive tumor cells indicate poor prognosis of hepatocellular carcinoma after curative resection. Hepatology. 2013 Apr;57(4):1458-68. doi: 10.1002/hep.26151. Epub 2013 Mar 4.
citation: Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.
citation: Ren ZG, Lin ZY, Xia JL, Ye SL, Ma ZC, Ye QH, Qin LX, Wu ZQ, Fan J, Tang ZY. Postoperative adjuvant arterial chemoembolization improves survival of hepatocellular carcinoma patients with risk factors for residual tumor: a retrospective control study. World J Gastroenterol. 2004 Oct 1;10(19):2791-4. doi: 10.3748/wjg.v10.i19.2791.