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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01512407
Recruitment Status : Unknown
Verified February 2015 by Cheung Yue Sun, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : January 19, 2012
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):
Cheung Yue Sun, Chinese University of Hong Kong

January 14, 2012
January 19, 2012
February 4, 2015
January 2012
January 2017   (Final data collection date for primary outcome measure)
1-year recurrence rate [ Time Frame: 1-year after hepatectomy ]
The 1-year recurrence rate after hepatectomy in both arms of study were compared
Same as current
Complete list of historical versions of study NCT01512407 on Archive Site
  • Disease-free survival [ Time Frame: 5 years after operation ]
  • Overall Survival [ Time Frame: 5-year after surgery ]
  • Complications of transarterial chemoembolisation [ Time Frame: 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)
Same as current
Not Provided
Not Provided
RCT on Adjuvant TACE After Hepatectomy for HCC
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma
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
  • Experimental: Hepatectomy plus TACE
    Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy
    Intervention: Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture
  • No Intervention: Hepatectomy alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2018
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Cheung Yue Sun, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Yue Sun Cheung, MBChB Chinese University of Hong Kong
Chinese University of Hong Kong
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP