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Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma

Phase 2
20 Years
69 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma

The primary end points are response rate and toxicities profile. The secondary endpoints are
time to disease-free survival, overall survival, and quality of life assessment.

Inclusion Criteria:

- 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.

Exclusion Criteria:

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Response rate

Outcome Description:

The tumor response rate will be evaluated at the 6th month after the ending of radiotherapy. The response rate includes complete and partial response according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Shang-Wen Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, China Medical University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

September 2010

Completion Date:

December 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • radiotherapy
  • sorafenib
  • Carcinoma
  • Carcinoma, Hepatocellular