Hepatocellular Carcinoma, Portal Vein Thrombosis
Conditions
Brief summary
Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE). Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
Interventions
PROCEDUREneo-TACE-HAIC+Surgery
transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
PROCEDURESurgery alone
hepatic resection remove the liver tumor and portal vein tumor thrombus
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years; * Patients with resectable primary hepatocellular carcinoma and portal vein tumor thrombus, which was not located in main portal vein; * Child-Pugh A or B (7 score) liver function; * With more than 3 months expected survival; * The volume of residual liver more than 30%
Exclusion criteria
* Patients with primary hepatocellular carcinoma and major portal vein tumor thrombus * With extrahepatic metastasis or unresectable HCC * Pregnant woman or sucking period; * With other malignant cancer; * Received chemotherapy, target therapy or immunosuppressive drugs therapy before this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival, PFS | 36 months | PFS was calculated from the date of starting treatment to the date of progression, of disease or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival, OS | 60 months | OS was calculated from the date of starting treatment to the date of death. |
Countries
China
Contacts
Primary ContactJiliang Qiu, MD.
Outcome results
None listed