NCT00849264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

February 19, 2009

Last Update Submit

March 30, 2016

Conditions

Hepatocellular CarcinomaPortal Vein Tumor Thrombus

Keywords

hepatocellular carcinomaportal vein tumor thrombussurgical comprehensive treatment

Outcome Measures

Primary Outcomes (1)

  • overall survival

    2010

Secondary Outcomes (1)

  • disease-free survival

    1,2 and 3 years

Study Arms (3)

A

EXPERIMENTAL

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

Drug: chemotherapy with endostar

B

ACTIVE COMPARATOR

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

C

EXPERIMENTAL

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

chemotherapy with endostarDRUG

15mg/d×14d

Also known as: chemotherapy with endostar group
A
treatment with CBP and 5-FUDRUG

CBP 300mg/d×2d，5-FU 1000mg/d×5d

Also known as: treatment with CBP and 5-FU group
B
treatment with endostar, CBP and 5-FUDRUG

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

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

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Drug Therapyendostar proteinTherapeuticsFluorouracil

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Feng Shen, M.D.

    Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 23, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

April 1, 2016

Record last verified: 2016-03

Locations

CN(1)