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Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma


Phase 4
18 Years
85 Years
Open (Enrolling)
Both
Unresectable Hepatocellular Carcinoma

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Trial Information

Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma


Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more
than 28%. The TACE treatment, under the theoretical basis of blood supply of Liver cancer,
is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP
decrease, survival time and the evaluation of the quality of life. Licartin injection is a
antibody drug with new target and the only drug that China own the intellectual property
rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen.
Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β
particles to liver cancer cells to and kill cancer cells.

The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to
use the treatment of Licartin combined with TACE for the patients of unresectable
hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the
overall survival rate between different treatment group.


Inclusion Criteria:



1. the participation is entirely voluntary, good at compliance, sign the informed
consent form in person;

2. diagnosed to be hepatocellular carcinoma by clinical method, imaging method and
tumor markers; and the surgeons determine who can not undergo surgery;

3. confirmed to recurrent after surgery by pathology;

4. KPS score of physical state ≥ 60 points;

5. liver function is Child-Pugh A or B class

Exclusion Criteria:

1. General situation is poor and liver function Child-Pugh is C class;

2. there is a serious heart, kidney and blood system diseases in patients;

3. poor compliance;

4. there is allergy history of biological agents or in a state of allergy;

5. pregnancy and breast-feeding women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

OS of 1 years; TTP

Outcome Time Frame:

2008.12--2010-12

Safety Issue:

Yes

Principal Investigator

Yang yefa, doctor

Investigator Role:

Study Director

Investigator Affiliation:

The Second Military Medical University

Authority:

China: Food and Drug Administration

Study ID:

EHBH-RCT-2008-013

NCT ID:

NCT00829465

Start Date:

December 2008

Completion Date:

December 2010

Related Keywords:

  • Unresectable Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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