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

Hepatocellular Carcinoma Clinical Trial

Official title:

Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03313596
• Other study ID #: LT-03
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Huazhong University of Science and Technology
• Contact: Danhui Weng, Dr.
• Phone: 027-83663351
• Email: weng.dh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• 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

Locations

Country	Name	City	State
China	301 Military Hospital	Beijing
China	Beijing Youan Hospital	Beijing	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	Urumqi

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Beijing YouAn Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival, PFS	PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.	2-year
Secondary	Overall survival, OS	OS was measured from the day of liver transplantation to death.	1-year
Secondary	Overall survival, OS	OS was measured from the day of liver transplantation to death.	2-year
Secondary	Time of the tumor progression,TTP	TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).	2-year
Secondary	Median overall survival time		2-year