Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC

March 31, 2016 updated by: Hai-Bin Shi, Nanjing Medical University

A Randomized Controlled Trial of Ethanol-gelfoam Mixture(EGM) Versus Gelfoam for the Treatment of Arterioportal Shunts (APS) in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolization (TACE)

Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.

Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).

The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Haibin Shi, MD, PhD.
  • Phone Number: 086-025 681 369 18
  • Email: shihb@njmu.edu.cn

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhong da hospital, Southeast university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Child-Pugh A or B cirrhosis
  • ECOG performance status Grade 2 or below
  • No serious concurrent medical illness
  • No prior treatment (including surgery) for HCC
  • Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
  • Unresectable and locally advanced disease without extra-hepatic disease
  • Massive expansive or nodular tumor morphology with measurable lesion on CT
  • Size of largest tumor <= 15cm in largest dimension
  • Number of main tumor <= 5, excluding associated small satellite lesions
  • Arterioportal shunts (APS) is found in the angiography of HCC blood supply

Exclusion Criteria:

  • History of prior malignancy except skin cancer
  • History of significant concurrent medical illness such as ischemic heart disease or heart failure
  • History of acute tumor rupture
  • Serum creatinine level > 180 umol/L
  • Presence of biliary obstruction not amenable to percutaneous drainage
  • Child-Pugh C cirrhosis
  • History of hepatic encephalopathy, or
  • Intractable ascites not controllable by medical therapy, or
  • History of variceal bleeding within last 3 months, or
  • Serum total bilirubin level > 50 umol/L, or
  • Serum albumin level < 28g/L, or
  • INR > 1.3
  • Presence of extrahepatic metastasis
  • Predominantly infiltrative lesion
  • Diffuse tumor morphology with extensive lesions involving both lobes.
  • Hepatic artery thrombosis, or
  • Partial or complete thrombosis of the main portal vein, or
  • Tumor invasion of portal branch of contralateral lobe, or
  • Hepatic vein tumor thrombus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TACE+EGM
Occlude APS with EGM and perform TACE sequentially
Procedure: TACE
Transarterial chemoembolisation (TACE)
Drug: EGM
Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
Active Comparator: TACE+PVA
Occlude APS with PVA and perform TACE sequentially
Procedure: TACE
Transarterial chemoembolisation (TACE)
Drug: PVA
Occlude arterioportal shunts(APS) with PVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years
Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
3 years
APS improvement
Time Frame: 2 month
Changes of Arterioportal Shunts Treated with PVA or EGM
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Progression
Time Frame: every 8 weeks, upto 3 years from date of randomization
Time from randomization to radiological progression. Definition of progression is based on the mRECIST criteria. Deaths during follow-up without evidence of radiological progression are censored.
every 8 weeks, upto 3 years from date of randomization
progression free survival
Time Frame: every 8 weeks, upto 3 years from date of randomization
Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored.
every 8 weeks, upto 3 years from date of randomization
Response Rate
Time Frame: every 8 weeks, upto 3 years from date of randomization
Definition of response is based on the mRECIST criteria.
every 8 weeks, upto 3 years from date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Investigators

  • Principal Investigator: Haibin Shi, MD, PhD., The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

January 11, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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