NCT01952353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

7.5 years

First QC Date

September 24, 2013

Last Update Submit

March 5, 2019

Conditions

Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Keywords

Hepatocellular Carcinoma; Transarterial Chemoembolization; Hepatic Resection; Portal Vein Tumor Thrombosis

Outcome Measures

Primary Outcomes (1)

  • overall survival time

    5years

Secondary Outcomes (2)

  • disease free survival

    5 years

  • Number of Adverse Events

    30 days

Study Arms (2)

Preoperation TACE arm

EXPERIMENTAL

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

Procedure: Preoprative TACEProcedure: Liver resection plus Thrombectomy

Resection arm

ACTIVE COMPARATOR

Liver resection Plus Thrombectomy

Procedure: Liver resection plus Thrombectomy

Interventions

Preoprative TACEPROCEDURE
Also known as: Preoperative transarterial chemoembolization
Preoperation TACE arm
Liver resection plus ThrombectomyPROCEDURE

Liver resection plus Thrombectomy

Also known as: Removal of all tumor tissue by surgery
Preoperation TACE armResection arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunYat-sen University cancer center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • 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.

    PMID: 22359112RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

HepatectomyThrombectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Ming Shi, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

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

September 24, 2013

First Posted

September 27, 2013

Study Start

February 1, 2006

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

CN(1)