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
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|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: ADV-Tk Procedure: LT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: LT-only
patients received orthotopic LT and subsequent immunosuppression therapy
Orthotopic LT and subsequent immunosuppression therapy
ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
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.
Orthotopic LT and subsequent immunosuppression therapy
- 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.
- 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 ]
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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|
- 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.
- 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.
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
|Contact: Danhui Weng, Dr.||email@example.com|
|Beijing Youan Hospital||Recruiting|
|Beijing, Beijing, China, 10001|
|Contact: Ning Li, Dr|
|301 Military Hospital||Recruiting|
|Contact: Jiahong Dong|
|General Hospital of Chinese People's Armed Police||Recruiting|
|Contact: Yunjin Zang|
|The Third XiangYa Hospital of Central South University||Recruiting|
|Contact: Qifa Ye|
|West China Hospital of Sichuan University||Recruiting|
|Contact: Lvnan Yan|
|The Third Affiliated Hospital,Sun Yat-sen University||Recruiting|
|Contact: Guihua Chen|
|The First Affiliated Hospital, Zhejiang University||Recruiting|
|Contact: Shusen Zheng|
|Zhongshan Hospital of Fudan University||Recruiting|
|Contact: Jia Fan|
|The First Affiliated Hospital of China Medical University||Recruiting|
|Contact: Yongfeng Liu|
|The First Center Hospital of Tianjin||Recruiting|
|Contact: Zhongyang Shen|
|The First Hospital of Xinjiang Medical University||Recruiting|
|Contact: Hao Wen|
|Responsible Party:||Ding Ma, Director, Huazhong University of Science and Technology|
|Other Study ID Numbers:||
|First Posted:||October 18, 2017 Key Record Dates|
|Last Update Posted:||February 4, 2019|
|Last Verified:||February 2019|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases