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Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma

Phase 4
18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma, Face Cancer

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Trial Information

Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients
present with intermediate or advanced disease. Percutaneous ethanol injection,
radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not
considered as a curative treatment and have achieved very limited success in eradicating
large HCC.

Two phase III trials were shown to be efficacious and well-tolerated in patients with
advanced HCC. Median overall survival was significantly 2 to 3 months longer in the
sorafenib group than that in the placebo. It is interesting to recognize the combined
therapeutic effect of TACE with sorafenib. The proposed study will make an important
contribution to understanding not only the safety and efficacy of sorafenib in addition to
TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical
trial prospectively to compare the effectiveness of sorafenib combined with TACE with that
of TACE alone in the treatment of unresectable HCC

Inclusion Criteria:

1. Adults patients ( 18-75 years of age) with a diagnosis of HCC which is not amenable
to surgical resection or local ablative therapy

2. Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger
than 2 cm with typical vascular features or AFP > 200

3. Patient must have quantifiable disease limited to the liver

4. Patients must have at least one tumor lesion that meets both of the following

5. The lesion can be accurately measured in at least one dimension according to RECIST

6. The lesion has not been previously treated with surgery, radiation therapy,
radiofrequency ablation, percutaneous ethanol or acetic acid injection, or

7. ECOG performance status (PS) <2

8. No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At
least 4 weeks since prior systemic chemotherapy,At least 4 weeks since prior TACE, At
least 4 weeks since prior interferon.

9. Not pregnant

10. No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A

11. No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on

12. No current infections requiring antibiotic therapy

13. Not on anticoagulation or suffering from a known bleeding disorder

14. No unstable coronary artery disease or recent MI

Exclusion Criteria:

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

2. Renal failure requiring hemo- or peritoneal dialysis

3. Child-Pugh B & C hepatic impairment

4. History of cardiac disease: > NY Heart Association (NYHA) class 2 congestive heart
failure, active coronary artery disease, cardiac arrhythmias requiring
anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled
hypertension. Myocardial infarction more than 6 months prior to study entry is

5. Active clinically serious infections (> CTCAEv3 grade 2)

6. Known history of HIV

7. Known central nervous system tumors including metastatic brain disease

8. History of organ allograft

9. Substance abuse (current), psychological, or social conditions that may interfere
with the patient's participation in the study or evaluation of the study results.

10. Known or suspected allergy to the investigational agents or any agent given in
association with this trial.

11. Patients unable to swallow oral medications.

12. Pregnant or breast-feeding patients. Women of childbearing potential must have a
negative pregnancy test performed within seven days prior to the start of the study
drug. Both men and women enrolled in this trial must use adequate barrier birth
control measures during the course of the trial.

13. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

14. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
blood pressure > 90 mmHg, despite optimal medical management

15. Thrombolic or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months

16. Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of
study drug

17. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
study drug

18. Serious non-healing wound, ulcer, or bone fracture

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Effectiveness of sorafenib combined with TACE

Outcome Description:

Measure:overall survival Measured from the date of TACE until the date of death or last visit

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-Sen University


China: Ministry of Health

Study ID:




Start Date:

January 2010

Completion Date:

December 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Face Cancer
  • TACE
  • Sorafenib
  • overall survival
  • time to progression
  • Carcinoma
  • Carcinoma, Hepatocellular