Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

March 5, 2019 updated by: Shi Ming, Sun Yat-sen University

Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Mixing the Chemotherapy With Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

TACE is considered the standard treatment for unresectable HCC on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

668

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
    • Guangdong
      • Guangzhou, Guangdong, China
        • Cancer Center Sun Yat-sen 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility criteria:

Inclusion Criteria:

  • Adults patients with a diagnosis of HCC which is not amenable to surgical resection ,local ablative therapy and any other cured treatment.
  • Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
  • No serious concurrent medical illness
  • Unresectable BCLC stage A-B disease
  • No cirrhosis or cirrhotic status of Child-Pugh class A
  • No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
  • No current infections requiring antibiotic therapy
  • Not on anticoagulation or suffering from a known bleeding disorder
  • No unstable coronary artery disease or recent MI

  • The following laboratory parameters:

    • Platelet count ≥ 60,000/µL
    • Hemoglobin ≥ 8.5 g/dL
    • Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
    • ASL and AST ≤ 5 x upper limit of normal
    • Serum creatinine ≤ 1.5 x upper limit of normal
    • INR ≤ 1.5 or PT/APTT within normal limits
    • Absolute neutrophil count (ANC) >1,500/mm3
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

  • Known history of HIV
  • History of organ allograft
  • Pregnant or breast-feeding patients
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
  • Serious non-healing wound, ulcer, or bone fracture
  • Known central nervous system tumors including metastatic brain disease
  • severe Arterioportal Shunts or Arteriavein Shunts

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: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: infusion group
Infusion of anticancer agent followed by Embolization
Other: Embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Infusion of anticancer agent
infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water
Experimental: lipiodol chemotherapy group
Infusion of mixture of anticancer agent and lipiodol followed by Embolization
Other: Embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Infusion of mixture of anticancer agent and lipiodol
infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: 3 year
3 year

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Ming Shi, MD, Cancer Center, Sun Yat-set University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (Estimate)

October 28, 2010

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC_S010

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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