RCT on Adjuvant TACE After Hepatectomy for HCC

Hepatocellular Carcinoma Clinical Trial

— A-TECH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512407
• Other study ID #: CRE-2011.236-T
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2019

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year recurrence rate	The 1-year recurrence rate after hepatectomy in both arms of study were compared	1-year after hepatectomy
Secondary	Disease-free survival		5 years after operation
Secondary	Overall Survival		5-year after surgery
Secondary	Complications of transarterial chemoembolisation		3-month after transarterial chemoembolisation
Secondary	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)	1-year after surgery