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TACE as an Adjuvant Therapy After Hepatectomy for HCC

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Ethiodized Oil + Doxorubicin

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma focused on measuring HCC, Randomised controlled trial, TACE, Resection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

TACE('Ethiodized Oil + Doxorubicin)

Arm Description

no interventions were assigned

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.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Overall Survival

Complications of transarterial chemoembolisation

Full Information

NCT ID

NCT01966133

First Posted

October 16, 2013

Last Updated

January 6, 2017

Sponsor

Jia Fan

1. Study Identification

Unique Protocol Identification Number

NCT01966133

Brief Title

TACE as an Adjuvant Therapy After Hepatectomy for HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2011 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jia Fan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

HCC, Randomised controlled trial, TACE, Resection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

no interventions were assigned

Arm Title

TACE('Ethiodized Oil + Doxorubicin)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ethiodized Oil + Doxorubicin

Other Intervention Name(s)

doxorubicin-lipiodol mixture

Intervention Description

TACE using doxorubicin-lipiodol mixture

Primary Outcome Measure Information:

Title

Disease-free survival

Time Frame

3 years after operation

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

3-year after surgery

Title

Complications of transarterial chemoembolisation

Time Frame

3-month after transarterial chemoembolisation

Other Pre-specified Outcome Measures:

Title

Health-related quality of life assessment

Description

The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)

Time Frame

1-year after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jia Fan, MD

Organizational Affiliation

Liver cancer institute, Fudan university

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jian Zhou, MD

Organizational Affiliation

Liver Cancer Institute, Zhong Shan Hospital, Fudan University

Official's Role

Study Director

Facility Information:

Facility Name

Zhongshan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

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TACE as an Adjuvant Therapy After Hepatectomy for HCC

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