Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase II Trial of TACE With Sorafenib in Patients With Locally Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01170104
• Other study ID #: CAUHHO 2009-1
• Status: Recruiting
• Phase: Phase 2
• First received: July 23, 2010
• Last updated: June 22, 2011
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: June 2009
• Source: Chung-Ang University
• Contact: Joung-Soon Jang, M.D.
• Phone: 82-2-6299-1427
• Email: alsaba[@]daum.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate the time to progression of the combination therapy of Transcatheter Arterial Chemoembolization (TACE) and sorafenib in patients with previously untreated advanced or metastatic hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: June 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Unresectable Hepatocellular carcinoma with local liver lesion treatable with TACE

2. Age > 18 years.

3. ECOG Performance Status of 0 or 1.

4. Child-Pugh class A (class B could be included when Childs score is 7).

5. Life expectancy of at least 12 weeks.

6. Subjects with at least one measurable lesion.

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

• Hemoglobin > 9.0 g/dl

• Absolute neutrophil count (ANC) >1,500/mm3

• Platelet count > 75,000/µl

• Total bilirubin < 1.5 times the upper limit of normal

• ALT and AST < 2.5 x upper limit of normal (UNL)

• Alkaline phosphatase < 5 x ULN

• PT-INR/PTT < 1.5 x upper limit of normal

• Serum creatinine < 1.5 x ULN

8. Signed and dated informed consent before the start of specific protocol procedures

Exclusion Criteria:

1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.

2. History of HIV infection.

3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)

5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)

6. History of organ allograft The organ allograft may be allowed as protocol specific.

7. Patients with evidence or history of uncontrolled bleeding diathesis

8. Patients undergoing renal dialysis

9. 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.

10. Excluded therapies and medications, previous and concomitant:

• Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry

• Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study

• Investigational drug therapy outside of this trial during or within 4 weeks of study entry

• Prior exposure to the study drug.

• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).

• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study

• Patients unable to swallow oral medications

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib
Sorafenib (NEXAVAR, Bayer) will be administered after TACE continuous dosing from day 1 until progression or up to 6 cycles of TACE as an oral 400mg twice-daily without food (at least 1 hour before or 2 hours after eating).

Procedure:
• TACE (Transcatheter arterial chemoembolization)
Sorafenib (NEXAVAR, Bayer) will be administered after TACE continuous dosing from day 1 until progression or up to 6 cycles of TACE as an oral 400mg twice-daily without food (at least 1 hour before or 2 hours after eating).

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Dongjak	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chung-Ang University	Gyeongsang National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	Assessments including image and laboratory studies will take place within 7days of the every TACE cycle	2 year	No
Secondary	To evaluate the toxicity profiles	Clinically assessed every TACE cycle	2 year	No