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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Cheung Yue Sun, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01512407
First received: January 14, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 14, 2012
January 14, 2012
January 2012
January 2017   (final data collection date for primary outcome measure)
1-year recurrence rate [ Time Frame: 1-year after hepatectomy ] [ Designated as safety issue: No ]
The 1-year recurrence rate after hepatectomy in both arms of study were compared
Same as current
No Changes Posted
  • Disease-free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5-year after surgery ] [ Designated as safety issue: No ]
  • Complications of transarterial chemoembolisation [ Time Frame: 3-month after transarterial chemoembolisation ] [ Designated as safety issue: Yes ]
  • Health-related quality of life assessment [ Time Frame: 1-year after surgery ] [ Designated as safety issue: No ]
    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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
Not Provided
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
Both
18 Years to 70 Years
No
Contact: Yue Sun Cheung, MBChB (852) 26321411 yuesun@surgery.cuhk.edu.hk
China
 
NCT01512407
CRE-2011.236-T
No
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
January 2012

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