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Completed

NCT Number: NCT00849264

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chemotherapy with endostar

Drug

15mg/d×14d

Other names: chemotherapy with endostar group

treatment with CBP and 5-FU

Drug

CBP 300mg/d×2d,5-FU 1000mg/d×5d

Other names: treatment with CBP and 5-FU group

treatment with endostar, CBP and 5-FU

Drug

CBP 300mg/d×2d,5-FU 1000mg/d×5d ,Endostar 15mg/d×14d

Other names: endostar, CBP and 5-FU group

Primary outcomes

  1. overall survival

    Time frame: 2010

Secondary outcomes

  1. disease-free survival

    Time frame: 1,2 and 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Feb 23, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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