TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01869088
First received: February 16, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Recombinant Human Adenovirus Type 5 Injection
Procedure: Transartery Chemoembolization
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Overall survival time [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 )

  • Tumor response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Tumor response based on modified RECIST


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
  • BCLC stage 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869088

Contacts
Contact: Ming Shi, M.D 86-2087343582 ext 86-2087343582 shiming@mail.sysu.edu.cn
Contact: Rong Ping Guo, MD 86-2087343117 ext 86-2087343117 guorongp@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Ming Shi, MD    86-2087343582 ext 86-2087343582    shiming@mail.sysu.edu.cn   
Contact: Rong Ping Guo, MD    86-2087343117 ext 86-2087343117    guorongp@mail.sysu.edu.cn   
Principal Investigator: Ming Shi, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Ming Shi, MD Cancer Center, Sun Yat-set University
  More Information

Publications:

Responsible Party: Shi Ming, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01869088     History of Changes
Other Study ID Numbers: HCC-120402
Study First Received: February 16, 2013
Last Updated: May 30, 2013
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
TACE
Carcinoma,Hepatocellular
Liver Neoplasms
overall survival
Recombinant Human Adenovirus Type 5 Injection

Additional relevant MeSH terms:
Adenoviridae Infections
Carcinoma
Carcinoma, Hepatocellular
DNA Virus Infections
Virus Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 29, 2014