Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
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
Beijing Youan Hospital
Beijing, Beijing Municipality, China
RECRUITING301 Military Hospital
Beijing, China
RECRUITINGProgression-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.
Time frame: 2-year
Overall survival, OS
OS was measured from the day of liver transplantation to death.
Time frame: 1-year
Overall survival, OS
OS was measured from the day of liver transplantation to death.
Time frame: 2-year
Time of the tumor progression,TTP
TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).
Time frame: 2-year
Median overall survival time
Time frame: 2-year
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General Hospital of Chinese People's Armed Police
Beijing, China
RECRUITINGThe Third XiangYa Hospital of Central South University
Changsha, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, China
RECRUITINGThe Third Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University
Hangzhou, China
RECRUITINGZhongshan Hospital of Fudan University
Shanghai, China
RECRUITINGThe First Affiliated Hospital of China Medical University
Shenyang, China
RECRUITINGThe First Center Hospital of Tianjin
Tianjin, China
RECRUITING...and 1 more locations