TACE as an Adjuvant Therapy After Hepatectomy for HCC

Study Overview
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Brief Summary
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Investigators 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 of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor undergoing liver resection plus post-operative TACE versus liver resection alone.

Detailed Description
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Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver, especially for the patients with high risk factors for residual tumor, such as tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion. 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. The main complications of TACE are liver function damage, mild feverish symptoms, vomit , etc. But most of them are reversible. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients with high risk factors for residual tumor (tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion).

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Ethiodized Oil + Doxorubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCC patients received curative hepatectomy with negative resection margin Tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification. 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 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 doxorubicin or lipiodol Pregnant woman Informed consent not available

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>no interventions were assigned | |
| Active Comparator: TACE('Ethiodized Oil + Doxorubicin)<br>TACE using Ethiodized Oil + Doxorubicin mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4-6 weeks after surgery. | Drug: Ethiodized Oil + Doxorubicin<br>* TACE using doxorubicin-lipiodol mixture<br>* Other names: doxorubicin-lipiodol mixture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 3 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3-year after surgery | 
| Complications of transarterial chemoembolisation |  | 3-month after transarterial chemoembolisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, Randomised controlled trial, TACE, Resection