Know Cancer

forgot password

Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis.A Prospective and Randomized Clinical Trial

Phase 4
18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma With PVTT

Thank you

Trial Information

Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis.A Prospective and Randomized Clinical Trial

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most frequent
cause of cancer death worldwide. Hepatic resection (HR) is the conventional "curative"
treatment for HCC. In both the European and the Unit States Proposed Guidelines for HCC, HR
is recommended only for patients with preserved liver function and with a single HCC lesion.
Unfortunately, because of tumor multifocality, portal vein invasion, and underlying advanced
cirrhosis, only 10%-30% of HCCs are amenable to such a "curative" treatment at the time of
diagnosis. Transarterial chemoembolization (TACE) has become the most popular palliative
treatment for patients with unresectable HCC, and it is no longer considered as a
contraindication to HCC with portal vein tumor thrombus (PVTT). Unfortunately, the long term
outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT.

To improve on the results of treatment of HCC with PVTT, attempts have been made to perform
HR for these patients . HCC with PVTT remains a contraindication to liver transplantation
because of the high rate of tumor recurrence, and because of the severe shortage of donor
organs. HR remains the only therapeutic option that may still offer a chance of cure. With
advances in surgical techniques, it has become feasible to remove all gross tumors,
including PVTT which has extended to the main portal vein, safely by surgery. More HCC with
PVTT, which previously were considered as unresectable, have become resectable. Recent
studies have even shown favorable long-term survival outcomes of HR in well-selected cases
of HCC with PVTT. However, the survival outcomes of patients with HCC with PVTT treated with
HR or with TACE have not been properly compared.

This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat
patients with HCC with PVTT. The investigators also aimed to identify patient groups that
might benefit more from either treatment with HR or TACE.

Inclusion Criteria:

1. age between 18 and 75 years,

2. HCC with no previous treatment,

3. the presence of PVTT on imaging,

4. Eastern Co-operative Group performance status 0 ,

5. resectable disease, which is defined as the possibility of completely removing all
gross tumors and retaining a sufficient liver remnant to sustain life, as assessed by
our surgery team.

Exclusion Criteria:

1. the presence of extrahepatic spread on imaging,

2. a Child-Pugh class C liver cirrhosis, or ICG-R15 >30%, or evidence of hepatic
decompensation including ascites, esophageal or gastric variceal bleeding or hepatic

3. an American Society of Anesthesiologists (ASA) score ≥ 3

Type of Study:


Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

min-shan chen, Ph.D.,M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center, Sun Yat-set University


China: Ministry of Health

Study ID:




Start Date:

April 2010

Completion Date:

May 2013

Related Keywords:

  • Hepatocellular Carcinoma With PVTT
  • Carcinoma,Hepatocellular
  • Liver Neoplasms
  • Therapeutic
  • Chemoembolization,
  • TACE
  • hepatic resection
  • Carcinoma
  • Thrombosis
  • Carcinoma, Hepatocellular