UnknownNot Applicable

Combined Radiotherapy and Sorafenib in Patients With Hepatoma

Taiwan45 participantsStarted 2010-06

Plain-language summary

This study aims to test the efficacy of combined radiotherapy and sorafenib in patients with locally advanced hepatocellular carcinoma.

Age range20 Years – 69 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TAE.
✓. 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:
✓. Pretreatment blood count:

✕. Child-Pugh C
✕. CLIP score ≧ 4
✕. Patients with evidence of extrahepatic or metastatic disease
✕. Patients with evidence of massive ascites
✕. Patients receiving previous irradiation to liver
✕. Patients with previous use of Thalidomide less than 6 months from entering of the study
✕. 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)
✕. Active clinically serious infections ( \> grade 2 CTC version 2)

Response rate

Timeframe: 1-month and 6-month response rate

NCT IDNCT01319942

SponsorChina Medical University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-06

Shang-Wen Chen, MD