search
Back to results

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

Primary Purpose

Carcinoma, Hepatocellular

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TACE
EGM
PVA
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular Carcinoma, Arterioportal shunts, Transarterial Chemoembolization, Ethanol, Gelfoam, Polyvinyl Alcohol Foam Embolization Particles (PVA)

Eligibility Criteria

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

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

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • Zhong da hospital, Southeast universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TACE+EGM

TACE+PVA

Arm Description

Occlude APS with EGM and perform TACE sequentially

Occlude APS with PVA and perform TACE sequentially

Outcomes

Primary Outcome Measures

overall survival
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.
APS improvement
Changes of Arterioportal Shunts Treated with PVA or EGM

Secondary Outcome Measures

Time To Progression
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.
progression free survival
Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored.
Response Rate
Definition of response is based on the mRECIST criteria.

Full Information

First Posted
December 18, 2014
Last Updated
March 31, 2016
Sponsor
Nanjing Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02338297
Brief Title
Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Hepatocellular Carcinoma, Arterioportal shunts, Transarterial Chemoembolization, Ethanol, Gelfoam, Polyvinyl Alcohol Foam Embolization Particles (PVA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TACE+EGM
Arm Type
Experimental
Arm Description
Occlude APS with EGM and perform TACE sequentially
Arm Title
TACE+PVA
Arm Type
Active Comparator
Arm Description
Occlude APS with PVA and perform TACE sequentially
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
Transarterial chemoembolisation (TACE)
Intervention Type
Drug
Intervention Name(s)
EGM
Intervention Description
Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
Intervention Type
Drug
Intervention Name(s)
PVA
Intervention Description
Occlude arterioportal shunts(APS) with PVA
Primary Outcome Measure Information:
Title
overall survival
Description
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.
Time Frame
3 years
Title
APS improvement
Description
Changes of Arterioportal Shunts Treated with PVA or EGM
Time Frame
2 month
Secondary Outcome Measure Information:
Title
Time To Progression
Description
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.
Time Frame
every 8 weeks, upto 3 years from date of randomization
Title
progression free survival
Description
Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored.
Time Frame
every 8 weeks, upto 3 years from date of randomization
Title
Response Rate
Description
Definition of response is based on the mRECIST criteria.
Time Frame
every 8 weeks, upto 3 years from date of randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haibin Shi, MD, PhD.
Phone
086-025 681 369 18
Email
shihb@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibin Shi, MD, PhD.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi
Email
shihb@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Haibin Shi, MD, PhD.
Facility Name
Zhong da hospital, Southeast university
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaojun Teng, MD., PhD.
Phone
02583272121
Email
gjteng@vip.sina.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs