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

Primary Purpose

Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

chemotherapy with endostar

treatment with CBP and 5-FU

treatment with endostar, CBP and 5-FU

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, portal vein tumor thrombus, surgical comprehensive treatment

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm Description

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

PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU

PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival

Full Information

NCT ID

NCT00849264

First Posted

February 19, 2009

Last Updated

March 30, 2016

Sponsor

Eastern Hepatobiliary Surgery Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00849264

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

Keywords

hepatocellular carcinoma, portal vein tumor thrombus, surgical comprehensive treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU

Arm Title

Arm Type

Experimental

Arm Description

PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU

Intervention Type

Drug

Intervention Name(s)

chemotherapy with endostar

Other Intervention Name(s)

chemotherapy with endostar group

Intervention Description

15mg/d×14d

Intervention Type

Drug

Intervention Name(s)

treatment with CBP and 5-FU

Other Intervention Name(s)

treatment with CBP and 5-FU group

Intervention Description

CBP 300mg/d×2d，5-FU 1000mg/d×5d

Intervention Type

Drug

Intervention Name(s)

treatment with endostar, CBP and 5-FU

Other Intervention Name(s)

endostar, CBP and 5-FU group

Intervention Description

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

Primary Outcome Measure Information:

Title

overall survival

Time Frame

2010

Secondary Outcome Measure Information:

Title

disease-free survival

Time Frame

1,2 and 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Feng Shen, M.D.

Organizational Affiliation

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Eastern hepatobilliary surgery hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200438

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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