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Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma

Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02418988
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
41
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients' poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC. But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has multiple anticancer functions and does not have any of the immune-inhibitory effects of chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.

Condition or Disease Intervention/Treatment Phase
  • Drug: TACE plus rAd-p53 artery injection
  • Drug: TACE
 Phase 2

Detailed Description

Study design: multicenter, open-labeled, active-controlled phase II study

Study treatments: TACE combined with rAd-p53 injection vs.TACE. The treatments are given once per 21 days until the disease progression. For the experiment group, 2 X 1000,000,000,000 viral particles of rAd-p53 will be injected into the embolization artery.

Study objectives: efficacy and safety of the study treatments

Study endpoints: safety (adverse events, vital signs, lab tests, ECG and physical examination) and efficacy (progression-free survival, overall survival, and ECOG PS)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Multicenter, Open-labeled, Controlled Phase II Study: Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
Study Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: TACE plus rAd-p53

TACE plus rAd-p53 artery injection'

Drug: TACE plus rAd-p53 artery injection
Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
Other Names:
  • no other name

    		•
    Active Comparator: TACE

    TACE will be applied alone

    Drug: TACE
    Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days
    Other Names:
  • no other name

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later]

      overall survival

    Secondary Outcome Measures

    1. safety as assessed by adverse events, vital sign, lab tests, ECG and physical examination [from the first study treatment to the 30 days after the last treatment (on an average of 6 months from the start treatment)]

      safety variables: adverse events, vital sign, lab tests, ECG and physical examination

    2. progression-free survival [tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later]

      time to disease progression (death or progression), or censored

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. histopathologically diagnosed HCC;

    2. unresectable;

    3. over 18 years old;

    4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;

    5. with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C;

    6. with Child-Pugh score A or B;

    7. with normal tests of hemogram, blood coagulation, liver and kidney function; 8. signed the informed consent form.

    Exclusion Criteria:

    1. Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;

    2. have serious heart, lung function abnormalities or severe diabetes patients;

    3. active infection;

    4. liver function Child-Pugh grade C;

    5. secondary and diffuse hepatocellular carcinoma patients;

    6. extensive metastasis;

    7. severe atherosclerosis;

    8. AIDS patients;

    9. serious thrombotic or embolic events within 6 months;

    10. renal insufficiency requiring hemodialysis or peritoneal dialysis;

    11. pregnant or lactating women;

    12. mental disorder or disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hospital of the Fourth Military Medical University Xi An Shanxi China 710032

    Sponsors and Collaborators

    • Shenzhen SiBiono GeneTech Co.,Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen SiBiono GeneTech Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT02418988
    Other Study ID Numbers:
    • rAd-p53-H14006
    First Posted:
    Apr 17, 2015
    Last Update Posted:
    Apr 17, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Chlorotrianisene

    Study Results

    No Results Posted as of Apr 17, 2015