Combination Treatment for Advanced Liver Cancer

April 17, 2018 updated by: Zhiping Yan, Shanghai Zhongshan Hospital

Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TACE&Stents
chemoembolization combined with endovascular stents and iodine-125 seed strand implantation
Procedure: chemoembolization
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.
Device: endovascular stents implantation
Bare stents implant within portal vein.
Procedure: iodine-125 seed strand implantation
Iodine-125 seed strand implant within portal vein.
Active Comparator: TACE
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median survival time
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Disease Progression
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Shanghai Municipal Science and Technology Commission

Investigators

  • Principal Investigator: Zhinping Yan, MD, Department of Interventional Radiology, Zhongshan Hospital, Fudan University
  • Study Director: Jianjun Luo, MD, Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 25, 2014

First Submitted That Met QC Criteria

May 25, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-IR 2013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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