Hepatocellular Carcinoma, Portal Vein Tumor Thrombus
Conditions
Keywords
hepatocellular carcinoma, portal vein tumor thrombus, surgical comprehensive treatment
Brief summary
This study is working to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.
Detailed description
Primary liver cancer (PLC) has a great tendency to invade portal vein intravascularly, results in the formation of portal vein tumor thrombus (PVTT), which is a crucial factor that can worsen the prognosis of patients with PLC. In clinical, various treatments have been applied to improve this short-term prognosis, but there was no identical indication for treatment of PLC patients with different PVTT. The objective of this study is to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.
Interventions
DRUGchemotherapy with endostar
15mg/d×14d
DRUGtreatment with CBP and 5-FU
CBP 300mg/d×2d，5-FU 1000mg/d×5d
DRUGtreatment with endostar, CBP and 5-FU
CBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d
Sponsors
Eastern Hepatobiliary Surgery Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients \> 30 years and \<=60 years of age. * with a clinical diagnosis of primary liver cancer with PVTT, without any adjuvant therapy. * resectable tumors in the liver. * PVTT type for II or III (based on the PVTT type system established by our groups), confirmed through pre-operative imaging and pathologic examination. * liver function grade A or B of the Child-Pugh classification. * No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hb ≥95g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³. * Patients who can understand this trial and have signed information consent.
Exclusion criteria
* have had an allergic reaction following iodine or chemotherapeutic drugs. * with extrahepatic metastasis. * Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer. * liver function:Child C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 2010 |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival | 1,2 and 3 years |
Countries
China
Outcome results
None listed