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

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

Tracking Information

• First Submitted Date: October 8, 2017
• First Posted Date: October 18, 2017
• Last Update Posted Date: February 4, 2019
• Study Start Date: March 2013
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hepatocellular Carcinoma

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 13, 2017): 180
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03313596
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Ding Ma, Huazhong University of Science and Technology
• Study Sponsor: Huazhong University of Science and Technology
• Collaborators: Beijing YouAn Hospital
• Investigators: Not Provided
• PRS Account: Huazhong University of Science and Technology
• Verification Date: February 2019