TACE as an Adjuvant Therapy After Hepatectomy for HCC

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Ethiodized Oil + Doxorubicin

• Registration Number: NCT01966133
• Lead Sponsor: Jia Fan

Brief Summary

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

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).

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-21
• Primary Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE('Ethiodized Oil + Doxorubicin)	Ethiodized Oil + Doxorubicin	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years after operation

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3-year after surgery
Complications of transarterial chemoembolisation	3-month after transarterial chemoembolisation

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China