Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients
NCT ID: NCT00849264
Last Updated: 2016-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2008-12-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar
chemotherapy with endostar
15mg/d×14d
B
PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU
treatment with CBP and 5-FU
CBP 300mg/d×2d，5-FU 1000mg/d×5d
C
PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU
treatment with endostar, CBP and 5-FU
CBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d
Interventions
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chemotherapy with endostar
15mg/d×14d
treatment with CBP and 5-FU
CBP 300mg/d×2d，5-FU 1000mg/d×5d
treatment with endostar, CBP and 5-FU
CBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* with extrahepatic metastasis.
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
* liver function:Child C.
30 Years
60 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
Responsible Party
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ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Principal Investigators
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Feng Shen, M.D.
Role: STUDY_CHAIR
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Locations
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Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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EHBH-RCT-2008-004
Identifier Type: -
Identifier Source: org_study_id
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