TACE as an Adjuvant Therapy After Hepatectomy for HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01966133
• Other study ID #: LCI-125-009
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 16, 2013
• Last updated: January 6, 2017
• Start date: August 2011
• Est. completion date: August 2017

Study information

• Verified date: January 2017
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Ethiodized Oil + Doxorubicin
TACE using doxorubicin-lipiodol mixture

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jia Fan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related quality of life assessment	The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)	1-year after surgery	No
Primary	Disease-free survival		3 years after operation	No
Secondary	Overall Survival		3-year after surgery	No
Secondary	Complications of transarterial chemoembolisation		3-month after transarterial chemoembolisation	Yes