RCT on Adjuvant TACE After Hepatectomy for HCC

Study Overview
=================
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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatectomy plus TACE<br>Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy | Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture<br>* Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery<br>|
| No Intervention: Hepatectomy alone<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year recurrence rate | The 1-year recurrence rate after hepatectomy in both arms of study were compared | 1-year after hepatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 5 years after operation | 
| Overall Survival |  | 5-year after surgery | 
| Complications of transarterial chemoembolisation |  | 3-month after 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) | 1-year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, Randomised controlled trial, Transarterial chemoembolisation