TACE as an Adjuvant Therapy After Hepatectomy for HCC

NCT ID: NCT01966133

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-08-31

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).

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

Control

no interventions were assigned

Group Type: NO_INTERVENTION

No interventions assigned to this group

TACE('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.

Group Type: ACTIVE_COMPARATOR

Ethiodized Oil + Doxorubicin

Intervention Type: DRUG

TACE using doxorubicin-lipiodol mixture

Interventions

Ethiodized Oil + Doxorubicin

TACE using doxorubicin-lipiodol mixture

Intervention Type: DRUG

Other Intervention Names

doxorubicin-lipiodol mixture

Eligibility 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

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

Sponsors

Jia Fan

OTHER

Sponsor Role: lead

Responsible Party

Jia Fan

President of zhongshan hospital, Fudan University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jia Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Liver cancer institute, Fudan university

Jian Zhou, MD

Role: STUDY_DIRECTOR

Liver Cancer Institute, Zhong Shan Hospital, Fudan University

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LCI-125-009

Identifier Type: -

Identifier Source: org_study_id