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Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

Primary Purpose

Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Preoprative TACE
Liver resection plus Thrombectomy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus focused on measuring Hepatocellular Carcinoma; Transarterial Chemoembolization; Hepatic Resection; Portal Vein Tumor Thrombosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a) age between 18 and 75 years,
  • b) HCC with no previous treatment,
  • c) the presence of major PVTT or less on imaging,
  • d) Eastern Co-operative Group performance status 030 ,
  • e) resectable disease

Exclusion Criteria:

  • a) Child-Pugh class B or C liver cirrhosis, or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding or hepatic encephalopathy, or ICGR-15 >15%,
  • b) an American Society of Anesthesiologists (ASA) score ≥ 3,
  • c) the presence of distant metastasis or other malignant diseases

Sites / Locations

  • SunYat-sen University cancer center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preoperation TACE arm

Resection arm

Arm Description

In the preoperative TACE arm (Arm 2), patients underwent TACE followed by surgical resection. Preoperative TACE sessions were repeated once at 4-week intervals unless patients showed either PD or PVTT PD. Then, the patients were prepared for surgical resection, with the exception of those with unresectable disease after TACE For patients who had unresectable disease after TACE, plans for surgical resection were abandoned and the subsequent treatment course was determined by his/her attending oncologist

Liver resection Plus Thrombectomy

Outcomes

Primary Outcome Measures

overall survival time

Secondary Outcome Measures

disease free survival
Number of Adverse Events
All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.

Full Information

First Posted
September 24, 2013
Last Updated
March 5, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01952353
Brief Title
Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion
Official Title
Efficacy of Preoperative Transarterial Chemoembolization for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: A Prospective Non-Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Whether preoperative transarterial chemoembolization can prolong survival for the resectable hepatocellular carcinoma remains controversial, particularly in patients with portal vein tumor thrombi. This study designs to systematically identify and summarize the effect of preoperative TACE for resectable HCC with portal venous invasion.
Detailed Description
With various improvements in interventional radiology, since the 2005 practice guidelines issued by the American Association for the Study of Liver Diseases , transcatheter arterial chemoembolization has become one of the available locoregional therapies for HCC. Transcatheter arterial chemoembolization, which generally performed in intermediate-stage HCC patients, involves injection of an embolizing agent into the hepatic artery to deprive the tumor of its major nutrient source via embolization of the nutrient artery, resulting in ischemic necrosis of the tumor. To prevent intrahepatic recurrence due to portal vein invasion of the HCC tumor, therapeutic strategies such as preoperative TACE, and postoperative adjuvant chemotherapy have been tried. According to the latest and the most powerful evidence, however, preoperative TACE is not routinely recommended for patients undergoing hepatectomy to treat resectable HCC , and TACE may delay surgical treatment or decrease the resection volume of the liver, or it also may create a missed opportunity for surgical treatment. Rather than subject all these patients to such an invasive procedure and put them at risk for missing opportunity for surgical treatment, it may be better to select optimal candidates to receive surgical resection. Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. About whether preoperative transarterial chemoembolization is available for the resectable hepatocellular carcinoma with portal vein tumor thrombi, so far, has hardly been reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Keywords
Hepatocellular Carcinoma; Transarterial Chemoembolization; Hepatic Resection; Portal Vein Tumor Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoperation TACE arm
Arm Type
Experimental
Arm Description
In the preoperative TACE arm (Arm 2), patients underwent TACE followed by surgical resection. Preoperative TACE sessions were repeated once at 4-week intervals unless patients showed either PD or PVTT PD. Then, the patients were prepared for surgical resection, with the exception of those with unresectable disease after TACE For patients who had unresectable disease after TACE, plans for surgical resection were abandoned and the subsequent treatment course was determined by his/her attending oncologist
Arm Title
Resection arm
Arm Type
Active Comparator
Arm Description
Liver resection Plus Thrombectomy
Intervention Type
Procedure
Intervention Name(s)
Preoprative TACE
Other Intervention Name(s)
Preoperative transarterial chemoembolization
Intervention Type
Procedure
Intervention Name(s)
Liver resection plus Thrombectomy
Other Intervention Name(s)
Removal of all tumor tissue by surgery
Intervention Description
Liver resection plus Thrombectomy
Primary Outcome Measure Information:
Title
overall survival time
Time Frame
5years
Secondary Outcome Measure Information:
Title
disease free survival
Time Frame
5 years
Title
Number of Adverse Events
Description
All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a) age between 18 and 75 years, b) HCC with no previous treatment, c) the presence of major PVTT or less on imaging, d) Eastern Co-operative Group performance status 030 , e) resectable disease Exclusion Criteria: a) Child-Pugh class B or C liver cirrhosis, or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding or hepatic encephalopathy, or ICGR-15 >15%, b) an American Society of Anesthesiologists (ASA) score ≥ 3, c) the presence of distant metastasis or other malignant diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SunYat-sen University cancer center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22359112
Citation
Peng ZW, Guo RP, Zhang YJ, Lin XJ, Chen MS, Lau WY. Hepatic resection versus transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus. Cancer. 2012 Oct 1;118(19):4725-36. doi: 10.1002/cncr.26561. Epub 2012 Feb 22.
Results Reference
result
Links:
URL
http://www.sysucc.org.cn
Description
web site of Cancer Center, Sun Yat-sen University

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Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

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