TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

March 14, 2017 updated by: Shi Ming, Sun Yat-sen University

Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Transarterial chemoembolization (TACE) is currently one of the mainstays of palliative treatments worldwide for patients with unresectable Hepatocellular Carcinoma(HCC).However, the long term outcomes were generally poor for HCC patients treated with TACE. Recombinant Human Adenovirus Type 5, an E1B gene deleted adenovirus, is known to have a significant antitumor activity. In addition, local injection of recombinant human adenovirus type 5 can enhance the effect of antitumor therapies (chemotherapy and radiotherapy). The hypothesis is that patients with unresectable HCC may benefit from recombinant human adenovirus type 5 in combination with TACE.

Study Type

Interventional

Enrollment (Anticipated)

266

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

Inclusion Criteria:

  • Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
  • BCLC stage A or B
  • Child-Pugh class A or B (Child-Pugh score 7)
  • ECOG performance status of 0

  • Patients must have at least one tumor lesion that meets both of the following criteria:

    • The lesion can be accurately measured in at least one dimension according to RECIST criteria
    • The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
    • Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible
    • Local therapy must have been completed at least 4 weeks prior to baseline scan.
  • Haematology:Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
  • Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of normal
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

  • Tumor factors

    • Presence of extrahepatic metastasis
    • Predominantly infiltrative lesion
    • Diffuse tumor morphology with extensive lesions involving both lobes.

  • Vascular complications

    • Hepatic artery thrombosis, or
    • Partial or complete thrombosis of the main portal vein, or
    • Tumor invasion of portal branch of contralateral lobe, or
    • Hepatic vein tumor thrombus, or
    • Significant arterioportal shunt not amenable to shunt blockage

  • Liver function

    • Advanced liver disease: ascites, hepatic encephalopathy
    • Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry.

  • Others

    • Renal failure requiring hemo- or peritoneal dialysis
    • Pregnant or lactating women.
    • Active sepsis or bleeding.
    • Hypersensitivity to intravenous contrast agents.
    • The patient has received prior treatment for HCC target lesion.

    • History of cardiac disease

      • Congestive heart failure > NYHA class 2; active coronary artery disease
      • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
    • Hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management.
    • Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months.
    • The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions.
    • Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
    • Any active clinically serious infections (> grade 2 NCI-CTCAE ver 3.0)
    • HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)

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
Active Comparator: TACE Only
TACE with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.
Procedure: Transartery Chemoembolization
Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.
Experimental: TACE Plus Adenovirus
After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0*1011vp：0.5ml*3） will be first infused through the target artery of HCC patient and followed with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg) and lipiodol emulsion or/and polyvinyl alcohol particles(dependent on the tumor size) Procedure: TACE (Transcatheter arterial chemoembolization)
Procedure: Transartery Chemoembolization
Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.
Drug: Recombinant Human Adenovirus Type 5 Injection
After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0*1011vp：0.5ml*3） will be first infused through the target artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival time
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 30 days
Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Common Terminology Criteria for Adverse Events ( CTCAE )
30 days
Tumor response
Time Frame: 12 weeks
Tumor response based on modified RECIST
12 weeks

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

January 1, 2013

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

February 16, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-120402

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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