Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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a Randomized Controlled Study of Surgical Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients

Conditions
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Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

Intervention / Treatment
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* Drug: chemotherapy with endostar
* Drug: treatment with CBP and 5-FU
* Drug: treatment with endostar, CBP and 5-FU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar | Drug: chemotherapy with endostar<br>* 15mg/d×14d<br>* Other names: chemotherapy with endostar group;|
| Active Comparator: B<br>PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU | Drug: treatment with CBP and 5-FU<br>* CBP 300mg/d×2d，5-FU 1000mg/d×5d<br>* Other names: treatment with CBP and 5-FU group;|
| Experimental: C<br>PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU | Drug: treatment with endostar, CBP and 5-FU<br>* CBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d<br>* Other names: endostar, CBP and 5-FU group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 1,2 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, portal vein tumor thrombus, surgical comprehensive treatment