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Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC

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ClinicalTrials.gov Identifier: NCT03313596
Recruitment Status : Unknown
Verified February 2019 by Ding Ma, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : October 18, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Beijing YouAn Hospital
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Tracking Information
First Submitted Date  ICMJE October 8, 2017
First Posted Date  ICMJE October 18, 2017
Last Update Posted Date February 4, 2019
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
Progression-free survival, PFS [ Time Frame: 2-year ]
PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • Overall survival, OS [ Time Frame: 1-year ]
    OS was measured from the day of liver transplantation to death.
  • Overall survival, OS [ Time Frame: 2-year ]
    OS was measured from the day of liver transplantation to death.
  • Time of the tumor progression,TTP [ Time Frame: 2-year ]
    TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).
  • Median overall survival time [ Time Frame: 2-year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
Official Title  ICMJE Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
Brief Summary Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: ADV-Tk
    The first ADV-TK dose was administered during the operation; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into peritoneum tissues around the liver. The second and third ADV-TK dose was administered 60 days and 90 days after LT; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into the celiac artery (60 mL) and the superior mesenteric artery (40 mL) via femoral-artery puncture.
  • Procedure: LT
    Orthotopic LT and subsequent immunosuppression therapy
Study Arms  ICMJE
  • Active Comparator: LT-only
    patients received orthotopic LT and subsequent immunosuppression therapy
    Intervention: Procedure: LT
  • Experimental: LT+ADV-TK
    ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
    Interventions:
    • Drug: ADV-Tk
    • Procedure: LT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 - 65 years of age (Male and Female).
  • Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation.
  • Patients who had unresectable HCC with single tumor diameter > 5 cm and ≤ 10cm; or numbers of multiple tumors >3 and ≤ 5, and the total length of foci diameter ≤ 15 cm.
  • Serum AFP ≤ 10000 ng/ml before liver transplantation.
  • Child-pugh A-B.
  • No metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs.
  • Provide written informed consent before screening.

Exclusion Criteria:

  • Metastasis in extrahepatic organs.
  • HCC with Invasion in extrahepatic main vescular and extrahepatic organs.
  • Contraindications of operation of other organ system.
  • Hypersensitivity to adenovirus, GCV or similar drugs.
  • Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%).
  • Plan to accept clinical trials of other antitumor drugs.
  • Immunological deficit.
  • HBsAg(+) and HBcAb(+) donor.
  • Unsuitable participate assessed by investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03313596
Other Study ID Numbers  ICMJE LT-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ding Ma, Huazhong University of Science and Technology
Study Sponsor  ICMJE Huazhong University of Science and Technology
Collaborators  ICMJE Beijing YouAn Hospital
Investigators  ICMJE Not Provided
PRS Account Huazhong University of Science and Technology
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP