Hepatocellular Carcinoma
Conditions
Brief summary
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
Interventions
DRUGADV-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.
PROCEDURELT
Orthotopic LT and subsequent immunosuppression therapy
Sponsors
Beijing YouAn Hospital
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival, PFS | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival, OS | 1-year | OS was measured from the day of liver transplantation to death. |
| Time of the tumor progression,TTP | 2-year | TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT). |
| Median overall survival time | 2-year | — |
Countries
China
Contacts
Primary ContactDanhui Weng, Dr.
Outcome results
None listed