A-TECH: RCT on Adjuvant TACE After Hepatectomy for HCC

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT01512407

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hepatectomy plus TACE Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy	Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery
No Intervention: Hepatectomy alone

Arm

Intervention/Treatment

Experimental: Hepatectomy plus TACE

Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy

Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture

Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery

No Intervention: Hepatectomy alone

Outcome Measures

Primary Outcome Measures

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

Disease-free survival [5 years after operation]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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