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

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

a Randomized Controlled Study of Surgical 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2010
2010

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Investigators

  • Study Chair: Feng Shen, M.D., Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 23, 2009

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBH-RCT-2008-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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