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TACE as an Adjuvant Therapy After Hepatectomy for HCC

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ClinicalTrials.gov Identifier: NCT01966133
Recruitment Status : Unknown
Verified January 2017 by Jia Fan, Fudan University.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jia Fan, Fudan University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Ethiodized Oil + Doxorubicin Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
Study Start Date : August 2011
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
no interventions were assigned
Active Comparator: 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.
Drug: Ethiodized Oil + Doxorubicin
TACE using doxorubicin-lipiodol mixture
Other Name: doxorubicin-lipiodol mixture




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years after operation ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3-year after surgery ]
  2. Complications of transarterial chemoembolisation [ Time Frame: 3-month after transarterial chemoembolisation ]

Other Outcome Measures:
  1. Health-related quality of life assessment [ Time Frame: 1-year after surgery ]
    The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966133


Locations
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China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Jia Fan
Investigators
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Principal Investigator: Jia Fan, MD Liver cancer institute, Fudan university
Study Director: Jian Zhou, MD Liver Cancer Institute, Zhong Shan Hospital, Fudan University

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Responsible Party: Jia Fan, President of zhongshan hospital, Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT01966133     History of Changes
Other Study ID Numbers: LCI-125-009
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by Jia Fan, Fudan University:
HCC
Randomised controlled trial
TACE
Resection

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Liposomal doxorubicin
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action