Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedJanuary 23, 2019
January 1, 2019
3.5 years
May 13, 2012
January 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival time
5-years
Secondary Outcomes (1)
Number of Adverse Events
30 days
Study Arms (2)
Resection arm
EXPERIMENTALLiver resection Plus Thrombectomy
Best support care arm
NO INTERVENTIONBest supportive care
Interventions
Liver resection plus Thrombectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Child-Pugh class B or C liver cirrhosis
- An American Society of Anesthesiologists (ASA) score ≥ 3
- Extrahepatic metastasis
- Patients had access to sorafenib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Guangzhou 8th People's Hospitalcollaborator
- Kaiping Central Hospitalcollaborator
- The 458 Hospital of Chinese People's Liberation Armycollaborator
Study Sites (1)
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Related Publications (1)
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.
PMID: 16769542BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Shi, MD.
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 13, 2012
First Posted
May 16, 2012
Study Start
January 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2011
Last Updated
January 23, 2019
Record last verified: 2019-01