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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849264
• Other study ID #: EHBH-RCT-2008-004
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2009
• Last updated: March 30, 2016
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		2010	No
Secondary	disease-free survival		1,2 and 3 years	No