NCT02149771

Brief Summary

The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

May 25, 2014

Last Update Submit

April 17, 2018

Conditions

Hepatocellular CarcinomaHepatic Portal Vein Tumor Invasion

Keywords

hepatocellular carcinomaportal vein tumor thrombosisstentschemoembolization

Outcome Measures

Primary Outcomes (1)

  • Median survival time

    2 years

Secondary Outcomes (1)

  • Time to Disease Progression

    2 years

Study Arms (2)

TACE&Stents

EXPERIMENTAL

chemoembolization combined with endovascular stents and iodine-125 seed strand implantation

Procedure: chemoembolizationDevice: endovascular stents implantationProcedure: iodine-125 seed strand implantation

TACE

ACTIVE COMPARATOR

Transartery chemoembolisation（TACE） by administering Doxorubicin and Oxaliplatin mixed with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.

Procedure: chemoembolization

Interventions

chemoembolizationPROCEDURE

Conventional chemoembolisation by administering Doxorubicin and Oxaliplatin mix with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.

TACETACE&Stents
endovascular stents implantationDEVICE

Bare stents implant within portal vein.

TACE&Stents
iodine-125 seed strand implantationPROCEDURE

Iodine-125 seed strand implant within portal vein.

TACE&Stents

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI;
  • (2) Child-Pugh classification grade A or B；
  • （3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

You may not qualify if:

  • advanced liver disease (bilirubin levels \>3 mg/dL, ASTor ALT \>5 × upper limit of normal)；
  • Tumor invade the Inferior Vena Cava, extrahepatic spread;
  • contraindications for doxorubicin or oxaliplatin chemotherapy;
  • any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
  • renal failure,cardiac ejection fraction \<50 %) or end-stage disease；
  • patients who were not capable of cooperation during the procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Chemoembolization, Therapeutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Embolization, TherapeuticHemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Zhinping Yan, MD

    Department of Interventional Radiology, Zhongshan Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

  • Jianjun Luo, MD

    Department of Interventional Radiology, Zhongshan Hospital, Fudan University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 25, 2014

First Posted

May 29, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

CN(1)