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A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.


Phase 3
20 Years
70 Years
Not Enrolling
Both
Hepatocellular Carcinoma

Thank you

Trial Information

A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.


To compare the below things between PEIT group and TACE group

1. Survival

1. 5 year overall survival rate

2. Disease free survival rate

2. Recurrence a. recurrence rate


Inclusion Criteria:



- The evidences of HBV(+) &/or HCV(+) infection or liver cirrhosis

- Two to three tumor nodules with Child-Pugh classification A or single to three tumor
nodules with Child-Pugh classification B

- The maximal, longest diameter of tumor mass measured by CT finding should be less
than 2 cm.

- 1) Only for newly detected HCCs which were not treated before or 2) If treated
before, it should be noted that there is no evidence of recurrence within the latest
6 months and, and also it should be remotely recurred more than 2cm apart from
primary lesion.

- It should be compatible with the typical findings of HCCs radiologically(MD CT or
dynamic MRI)

Exclusion Criteria:

- In case of hepatic vein or portal vein invasion radiologically(CT or MRI)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival rate

Outcome Time Frame:

5 year

Safety Issue:

Yes

Principal Investigator

J H Yoon, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

07-2006-010

NCT ID:

NCT00357474

Start Date:

October 2005

Completion Date:

April 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC, TACE, PEIT
  • Carcinoma
  • Carcinoma, Hepatocellular

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