Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
Primary Purpose
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Liver resection plus Thrombectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus focused on measuring Hepatectomy, Thrombectomy, Hepatocellular carcinoma, Portal vein tumor thrombus
Eligibility Criteria
Inclusion Criteria:
- The diagnosis of HCC was made according to AASLD guidelines
- Main tumor ≥ 7 cm
- Imaging confirmed the presence of PVTT in the first branches but not
- Extend into the main trunk of portal vein
- Eastern Co-operative Group performance
- Resectable disease
Exclusion Criteria:
- Child-Pugh class B or C liver cirrhosis
- An American Society of Anesthesiologists (ASA) score ≥ 3
- Extrahepatic metastasis
- Patients had access to sorafenib.
Sites / Locations
- Cancer Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Resection arm
Best support care arm
Arm Description
Liver resection Plus Thrombectomy
Best supportive care
Outcomes
Primary Outcome Measures
Survival time
Secondary Outcome Measures
Number of Adverse Events
Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.
Full Information
NCT ID
NCT01600196
First Posted
May 13, 2012
Last Updated
January 22, 2019
Sponsor
Sun Yat-sen University
Collaborators
Guangzhou 8th People's Hospital, Kaiping Central Hospital, The 458 Hospital of Chinese People's Liberation Army
1. Study Identification
Unique Protocol Identification Number
NCT01600196
Brief Title
Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
Official Title
Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Guangzhou 8th People's Hospital, Kaiping Central Hospital, The 458 Hospital of Chinese People's Liberation Army
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.
Detailed Description
Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Keywords
Hepatectomy, Thrombectomy, Hepatocellular carcinoma, Portal vein tumor thrombus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resection arm
Arm Type
Experimental
Arm Description
Liver resection Plus Thrombectomy
Arm Title
Best support care arm
Arm Type
No Intervention
Arm Description
Best supportive care
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
Survival time
Time Frame
5-years
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis of HCC was made according to AASLD guidelines
Main tumor ≥ 7 cm
Imaging confirmed the presence of PVTT in the first branches but not
Extend into the main trunk of portal vein
Eastern Co-operative Group performance
Resectable disease
Exclusion Criteria:
Child-Pugh class B or C liver cirrhosis
An American Society of Anesthesiologists (ASA) score ≥ 3
Extrahepatic metastasis
Patients had access to sorafenib.
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
Cancer Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
16769542
Citation
Le Treut YP, Hardwigsen J, Ananian P, Saisse J, Gregoire E, Richa H, Campan P. Resection of hepatocellular carcinoma with tumor thrombus in the major vasculature. A European case-control series. J Gastrointest Surg. 2006 Jun;10(6):855-62. doi: 10.1016/j.gassur.2005.12.011.
Results Reference
background
Links:
URL
http://www.sysucc.org.cn
Description
web site of Cancer Center, Sun Yat-sen University
Learn more about this trial
Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
We'll reach out to this number within 24 hrs