RCT on Adjuvant TACE After Hepatectomy for HCC

NCT ID: NCT01512407

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2019-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hepatectomy plus TACE

Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy

Group Type: EXPERIMENTAL

Transarterial chemoembolisation using cisplatin-lipiodol mixture

Intervention Type: PROCEDURE

Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery

Hepatectomy alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Cheung Yue Sun

Dr Cheung Yue Sun

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yue Sun Cheung, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, , China

Countries

China

Other Identifiers

CRE-2011.236-T

Identifier Type: -

Identifier Source: org_study_id