RCT on Adjuvant TACE After Hepatectomy for HCC

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture

• Registration Number: NCT01512407
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-14
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-19
• Primary Completion: 2019-05
• Study Completion: 2019-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-05
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepatectomy plus TACE	Transarterial chemoembolisation using cisplatin-lipiodol mixture	Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy

Primary Outcome Measures

Name	Time	Method
1-year recurrence rate	1-year after hepatectomy	The 1-year recurrence rate after hepatectomy in both arms of study were compared

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5-year after surgery
Complications of transarterial chemoembolisation	3-month after transarterial chemoembolisation
Health-related quality of life assessment	1-year after surgery	The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)
Disease-free survival	5 years after operation

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China