Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

Phase 4

• Conditions: Carcinoma, Hepatocellular; Neoplastic Cells, Circulating
• Interventions: Procedure: TACE; Drug: Epirubicin; Drug: lipiodol

• Registration Number: NCT02631499
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Last Update Submitted: 2015-12-20
• Last Update Posted: 2015-12-22
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant TACE	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.
Adjuvant TACE	Epirubicin	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.
Adjuvant TACE	lipiodol	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.

Primary Outcome Measures

Name	Time	Method
Early recurrence rates	1 year after hepatectomy	Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	up to 3 years	OS was defined as the interval from date of HCC resection to death due to any cause.

Trial Locations

Locations (6)

Nantong Tumor Hospital; 🇨🇳 Nantong, Jiangsu, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Soochow, Jiangsu, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China

Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Zhongshan hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China