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
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 144
Study Start Date: January 2012
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512407

Contacts
Contact: Yue Sun Cheung, MBChB (852) 26321411 yuesun@surgery.cuhk.edu.hk

Locations
China
Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Yue Sun Cheung, MBChB    (852) 26321411    yuesun@surgery.cuhk.edu.hk   
Principal Investigator: Yue Sun Cheung, MBChB         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Yue Sun Cheung, MBChB Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Cheung Yue Sun, Dr Cheung Yue Sun, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01512407     History of Changes
Other Study ID Numbers: CRE-2011.236-T
Study First Received: January 14, 2012
Last Updated: January 14, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Hepatocellular Carcinoma
Randomised controlled trial
Transarterial chemoembolisation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014