Status:
UNKNOWN
Safety Study of Sorafenib Following Combined Therapy of Radiation and TACE for Liver Cancer
Lead Sponsor:
Fudan University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with liver cancer will receive interventional therapy plus radiotherapy. Maintenance Sorafenib will be taken after the completion of radiotherapy. Hypothesis of the current study is that Sora...
Detailed Description
Patients with solitary lesion (bigger than 5 cm in diameter) histologically or cytologically confirmed HCC receive TACE (1-3 cycles) plus 3DCRT/IMRT 4-6 weeks later. Maintenance Sorafenib will be admi...
Eligibility Criteria
Inclusion
- Age of equal or older than 18 years and not over 75 years with a life expectancy of at least 12 weeks;
- Karnofsky performance status (KPS) of ≥70;
- Histologically or cytologically confirmed HCC;
- BCLC stage B, solitary lesion (bigger than 5 cm in diameter) with tumor burden less than 50% of total liver volume;
- Liver function of Child-Pugh A;
- Technically unresectable, medically inoperable, or surgery declined by the patient;
- Normal renal function and adequate bone marrow reservation;
- Signed informed consent must be obtained prior to any study specific procedure.
Exclusion
- Presence of intrahepatic and/or extrahepatic metastases
- Previous received systemic therapy for liver cancer;
- History of radiotherapy to the liver;
- Indistinct tumor boundary on CT/MRI images;
- Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder tumors \[Ta, Tis and T1\];
- History of cardiac disease: congestive heart failure \> NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months;
- Concurrent uncontrolled medical conditions;
- Pregnancy or breast feeding;
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry;
- Psychiatric or medical unstable conditions that compromise the patient's ability to give informed consent.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00999843
Start Date
October 1 2009
End Date
October 1 2012
Last Update
October 22 2009
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032