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

March 5, 2022 updated by: Cheung Yue Sun, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year recurrence rate
Time Frame: 1-year after hepatectomy
The 1-year recurrence rate after hepatectomy in both arms of study were compared
1-year after hepatectomy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Yue Sun Cheung, MBChB, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 14, 2012

First Submitted That Met QC Criteria

January 14, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 5, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2011.236-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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