TACE as an Adjuvant Therapy After Hepatectomy for HCC

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jia Fan
• Treatments: Doxorubicin; Ethiodized Oil; Liposomal doxorubicin

Criteria

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