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


Phase 2
30 Years
60 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

2010

Safety Issue:

No

Principal Investigator

Feng Shen, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Authority:

China: Ministry of Health

Study ID:

EHBH-RCT-2008-004

NCT ID:

NCT00849264

Start Date:

December 2008

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Portal Vein Tumor Thrombus
  • hepatocellular carcinoma
  • portal vein tumor thrombus
  • surgical comprehensive treatment
  • Carcinoma
  • Thrombosis
  • Carcinoma, Hepatocellular

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