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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00849264
First received: February 19, 2009
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Portal Vein Tumor Thrombus
Drug: chemotherapy with endostar
Drug: treatment with CBP and 5-FU
Drug: treatment with endostar, CBP and 5-FU
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: a Randomized Controlled Study of Surgical Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease-free survival [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: endostar, CBP and 5-FU group

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849264

Locations
China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Feng Shen, M.D. Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

No publications provided

Responsible Party: Shu-qun Cheng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00849264     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-004
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
hepatocellular carcinoma
portal vein tumor thrombus
surgical comprehensive treatment

Additional relevant MeSH terms:
Carcinoma
Thrombosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014