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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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Brief Summary:
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: ADV-Tk Procedure: LT Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : March 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LT-only
patients received orthotopic LT and subsequent immunosuppression therapy
 Procedure: LT
Orthotopic LT and subsequent immunosuppression therapy
Experimental: LT+ADV-TK
ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival, OS [ Time Frame: 1-year ]
    OS was measured from the day of liver transplantation to death.

  2. Overall survival, OS [ Time Frame: 2-year ]
    OS was measured from the day of liver transplantation to death.

  3. 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).

  4. Median overall survival time [ Time Frame: 2-year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313596


Contacts
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Contact: Danhui Weng, Dr. 027-83663351 weng.dh@gmail.com

Locations
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China, Beijing
Beijing Youan Hospital Recruiting
Beijing, Beijing, China, 10001
Contact: Ning Li, Dr         
China
301 Military Hospital Recruiting
Beijing, China
Contact: Jiahong Dong         
General Hospital of Chinese People's Armed Police Recruiting
Beijing, China
Contact: Yunjin Zang         
The Third XiangYa Hospital of Central South University Recruiting
Changsha, China
Contact: Qifa Ye         
West China Hospital of Sichuan University Recruiting
Chengdu, China
Contact: Lvnan Yan         
The Third Affiliated Hospital,Sun Yat-sen University Recruiting
Guangzhou, China
Contact: Guihua Chen         
The First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, China
Contact: Shusen Zheng         
Zhongshan Hospital of Fudan University Recruiting
Shanghai, China
Contact: Jia Fan         
The First Affiliated Hospital of China Medical University Recruiting
Shenyang, China
Contact: Yongfeng Liu         
The First Center Hospital of Tianjin Recruiting
Tianjin, China
Contact: Zhongyang Shen         
The First Hospital of Xinjiang Medical University Recruiting
Urumqi, China
Contact: Hao Wen         
Sponsors and Collaborators
Huazhong University of Science and Technology
Beijing YouAn Hospital
More Information
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Responsible Party: Ding Ma, Director, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03313596    
Other Study ID Numbers: LT-03
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases