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CompletedNCT00849264Updated Apr 1, 2016

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

A Phase 2 interventional study of chemotherapy with endostar and treatment with CBP and 5-FU in Hepatocellular Carcinoma and Portal Vein Tumor Thrombus, sponsored by Eastern Hepatobiliary Surgery Hospital. Completed at 1 site in China. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-04-01.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Portal Vein Tumor Thrombus

Keywords

  • hepatocellular carcinoma
  • portal vein tumor thrombus
  • surgical comprehensive treatment
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 120 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 66 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    A

    PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar

    Drug: chemotherapy with endostar

  • 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

  • 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

Interventions

  • Drugchemotherapy with endostar

    15mg/d×14d

    Also known as: chemotherapy with endostar group

  • Drugtreatment with CBP and 5-FU

    CBP 300mg/d×2d，5-FU 1000mg/d×5d

    Also known as: treatment with CBP and 5-FU group

  • Drugtreatment with endostar, CBP and 5-FU

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

    Also known as: endostar, CBP and 5-FU group

06

What researchers measure

Primary outcomes

  1. overall survival

    Time frame: 2010

Secondary outcomes

  1. disease-free survival

    Time frame: 1,2 and 3 years

07

Study locations

1 site
  • Eastern hepatobilliary surgery hospital
    Shanghai, Shanghai 200438, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00849264
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Responsible party
ShenFeng (vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
Feb 23, 2009
Start date
Dec 2008
Primary completion
Dec 2009
Completion
Dec 2010
Last update
Apr 1, 2016

Study contacts

Feng Shen, M.D.
study chair · Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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