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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transarterial chemoembolisation using cisplatin-lipiodol mixture
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Randomised controlled trial, Transarterial chemoembolisation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hepatectomy plus TACE

Hepatectomy alone

Arm Description

Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy

Outcomes

Primary Outcome Measures

1-year recurrence rate
The 1-year recurrence rate after hepatectomy in both arms of study were compared

Secondary Outcome Measures

Disease-free survival
Overall Survival
Complications of transarterial chemoembolisation
Health-related quality of life assessment
The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)

Full Information

First Posted
January 14, 2012
Last Updated
March 5, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01512407
Brief Title
RCT on Adjuvant TACE After Hepatectomy for HCC
Acronym
A-TECH
Official Title
Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Randomised controlled trial, Transarterial chemoembolisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatectomy plus TACE
Arm Type
Experimental
Arm Description
Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy
Arm Title
Hepatectomy alone
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Transarterial chemoembolisation using cisplatin-lipiodol mixture
Intervention Description
Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery
Primary Outcome Measure Information:
Title
1-year recurrence rate
Description
The 1-year recurrence rate after hepatectomy in both arms of study were compared
Time Frame
1-year after hepatectomy
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
5 years after operation
Title
Overall Survival
Time Frame
5-year after surgery
Title
Complications of transarterial chemoembolisation
Time Frame
3-month after transarterial chemoembolisation
Title
Health-related quality of life assessment
Description
The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)
Time Frame
1-year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Sun Cheung, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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RCT on Adjuvant TACE After Hepatectomy for HCC

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