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A Phase II Study of the Combination of TACE and Sorafenib for Patients With Unresectable Hepatocellular Carcinoma in National Cancer Center Korea (COTSUN Korea Trial)


Phase 2
20 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

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Trial Information

A Phase II Study of the Combination of TACE and Sorafenib for Patients With Unresectable Hepatocellular Carcinoma in National Cancer Center Korea (COTSUN Korea Trial)


Inclusion Criteria:



- Patients must provide signed written informed consent

- Patients with clinical or histological diagnosis of HCC based on the guidelines of
the Korean Liver Cancer Study Group and the National Cancer Center Korea

- Patients with at least one, bi-dimensionally measurable lesion by multiphasic spiral
CT scan or dynamic contrast-enhanced MRI

- Patients with stage III or IVa HCC according to modified International Union Against
Cancer TNM staging criteria without invasion in main portal vein, or inferior vena
cava and extrahepatic metastasis and size of largest tumor 10cm at study entry

- Patients with unresectable or inoperable HCC indicated for TACE as a treatment of
choice according to the guidelines of the Korean Liver Cancer Study Group and the
National Cancer Center Korea

- Age ≥ 20 years

- ECOG Performance Status of 0 or1

- Child-Pugh class A or B (Child-Pugh score 7)

- Life expectancy of at least 16 weeks

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to screening:

- Hb ≧ 9g/dl

- Absolute neutrophil count > 1000/mm3

- Platelet count ≧ 60x109/L

- Adequate clotting function: INR < 1.5

- Hepatic: AST or ALT < 5 X ULN

- Renal: serum creatinine < 1.5 x ULN

- Bilirubin ≦ 3mg/dL

Exclusion Criteria:

- Patients with diffuse infiltrative type of HCC that are poorly defined

- Presence of hepatic encephalopathy and intractable ascites

- Active clinically serious infections (> grade 2 NCI-CTC version 3.0), including
spontaneous bacterial peritonitis

- History of esophageal or gastric variceal bleeding

- Patients who are on a liver transplant list

- History of cardiac disease: congestive heart failure > NYHA class 2; active coronary
artery disease (myocardial infarction more than 6 months prior to study entry is
allowed), cardiac arrythmias requiring anti-arrythmic therapy or uncontrolled
hypertension and diabetes mellitis

- History of AIDS/HIV infection -Patients with seizure disorder requiring medication
(such as steroids or anti- epileptics)

- History of organ allograft

- Patients with evidence or history of bleeding diathesis

- Patients undergoing renal dialysis

- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study except cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors (Ta, Tis & T1) or any cancer curatively
treated > 3 years prior to study entry.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Time Frame:

1Year

Safety Issue:

Yes

Principal Investigator

Joong-Won Park, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center

Authority:

Korea: Food and Drug Administration

Study ID:

COTSUN Korea Trial

NCT ID:

NCT00919009

Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Carcinoma, Hepatocellular
  • TACE
  • Sorafenib
  • Carcinoma
  • Carcinoma, Hepatocellular

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