Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
NCT ID: NCT03313596
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2013-03-31
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
NCT00300521
Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
NCT02202564
Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation
NCT02580253
Hepatic Arterial Infusion Chemotherapy in Combination With Atezolizumab and Bevacizumab for Second-line Treatment of Patients With Recurrent Liver Cancer After Liver Transplantation
NCT05833126
Adjuvant Radiotherapy Comparing TACE for Curative HCC
NCT02125396
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LT-only
patients received orthotopic LT and subsequent immunosuppression therapy
LT
Orthotopic LT and subsequent immunosuppression therapy
LT+ADV-TK
ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
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.
LT
Orthotopic LT and subsequent immunosuppression therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
LT
Orthotopic LT and subsequent immunosuppression therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing YouAn Hospital
OTHER
Huazhong University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ding Ma
Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Youan Hospital
Beijing, Beijing Municipality, China
301 Military Hospital
Beijing, , China
General Hospital of Chinese People's Armed Police
Beijing, , China
The Third XiangYa Hospital of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
The Third Affiliated Hospital,Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Zhongshan Hospital of Fudan University
Shanghai, , China
The First Affiliated Hospital of China Medical University
Shenyang, , China
The First Center Hospital of Tianjin
Tianjin, , China
The First Hospital of Xinjiang Medical University
Ürümqi, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ning Li, Dr
Role: primary
Jiahong Dong
Role: primary
Yunjin Zang
Role: primary
Qifa Ye
Role: primary
Lvnan Yan
Role: primary
Guihua Chen
Role: primary
Shusen Zheng
Role: primary
Jia Fan
Role: primary
Yongfeng Liu
Role: primary
Zhongyang Shen
Role: primary
Hao Wen
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LT-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.