RCT on Adjuvant TACE After Hepatectomy for HCC (A-TECH)

The Chinese University of Hong Kong

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT01512407

CRE-2011.236-T

Details and patient eligibility

About

We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. The aim of this study is to compare the survival of patients undergoing liver resection plus post-operative TACE versus liver resection alone.

Full description

Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HCC patients received curative hepatectomy with negative resection margin
• Age from 18 to 70
• Child-Pugh class A
• ASA class I to III
• ECOG performance status Grade 0 or 1

Exclusion criteria

• Patients receiving concomitant local ablation or previous TACE
• Main portal vein tumour thrombus extraction during hepatectomy
• Tumour arising from caudate lobe
• Presence of extra-hepatic disease
• Very early HCC with solitary tumour and size < 2cm
• 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 cisplatin or lipiodol
• Pregnant woman
• Informed consent not available

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Hepatectomy plus TACE

Experimental group

Description:

Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy

Treatment:

Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture

Hepatectomy alone

No Intervention group