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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma; Portal Vein Tumor Thrombus
• Interventions: Drug: treatment with CBP and 5-FU; Drug: treatment with endostar, CBP and 5-FU; Drug: chemotherapy with endostar

• Registration Number: NCT00849264
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-23
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	treatment with CBP and 5-FU	PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU
C	treatment with endostar, CBP and 5-FU	PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU
A	chemotherapy with endostar	PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar

Primary Outcome Measures

Name	Time	Method
overall survival	2010

Secondary Outcome Measures

Name	Time	Method
disease-free survival	1,2 and 3 years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China