Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
- Patients with unresectable hepatoma with transarterial embolization (TAE) failure or
who are not suitable for TACE. A maximal tumor diameter > 3.0 cm.
- Age: 20 ~ 69 years.
- ECOG 0 or 1.
- Life expectancy of at least 12 weeks.
- Child-Pugh A or B (preferentially score ≦ 7).
- Cancer of the Liver Italian Program (CLIP) score ≦ 3.
- Pretreatment liver function test and renal function test:
- Total bilirubin < 1.5 times the upper limit of normal (ULN)(≦ 3.0 (ULN) in
patients treated by biliary drainage for obstructive jaundice)
- GOP/GPT ≦ 5 X of upper limit of normal range
- Alkaline phosphatase ≦ 4X of upper limit of normal range
- Prothrombin time/partial prothrombin time < 1.5 X of ULN
- Serum Creatinine ≦ 1.0 x ULN
- Pretreatment blood count:
- Hemoglobulin ≧ 9 g/dl
- Absolute neutrophil count ≧ 1500/mm3
- Platelet count ≧ 50,000/mm3
- Subjects with at least one uni-dimensional or bi-dimensional measurable lesion.
Lesion must be measured by CT scan or MRI.
- Patients must fully recover from prior therapy that given > 4 weeks before
- Signed informed consent must be obtained prior to any study related procedures.
1. Child-Pugh C
2. CLIP score ≧ 4
3. Patients with evidence of extrahepatic or metastatic disease
4. Patients with evidence of massive ascites
5. Patients receiving previous irradiation to liver
6. Patients with previous use of Thalidomide less than 6 months from entering of the
7. 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)
8. Active clinically serious infections ( > grade 2 CTC version 2)
9. Patients undergoing renal dialysis
10. Patients with evidence or history of bleeding diathesis
11. Prior treatment with EGFR TKIs or VEGFR TKIs
12. Hypertension uncontrolled by medical therapy
13. 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. Also
the patient must not be undergoing acute steroid therapy or taper.
14. Chemotherapy or immunotherapy or other systemic anti-cancer therapy within 4 weeks.