Safety Study of Sorafenib Following Combined Therapy of Radiation and TACE for Liver Cancer

Phase 1

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT00999843
• Lead Sponsor: Fudan University

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 Sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with interventional therapy in terms of survival in comparison to historical data.

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 administered only for the patients with non-progression disease 4 to 6 weeks after the completion of radiotherapy. The dose will be 400 mg, p.o., twice a day. Sorafenib will be continuously given for 12 months unless intolerable toxicities and/or tumor progression. Hypothesis of the current study is that Sorafenib as a maintenance therapy after combined therapy of 3DCRT/IMRT and TACE is safe and superior to radiotherapy combined with TACE alone in terms of time to progression (TTP), progression-free survival (PFS) and overall survival (OS) in comparison to historical data.

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Last Update Submitted: 2009-10-21
• Study First Posted: 2009-10-22
• Last Update Posted: 2009-10-22
• Primary Completion: 2010-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age of equal or older than 18 years and not over 75 years with a life expectancy of at least 12 weeks;
2. Karnofsky performance status (KPS) of ≥70;
3. Histologically or cytologically confirmed HCC;
4. BCLC stage B, solitary lesion (bigger than 5 cm in diameter) with tumor burden less than 50% of total liver volume;
5. Liver function of Child-Pugh A;
6. Technically unresectable, medically inoperable, or surgery declined by the patient;
7. Normal renal function and adequate bone marrow reservation;
8. Signed informed consent must be obtained prior to any study specific procedure.

Exclusion Criteria

1. Presence of intrahepatic and/or extrahepatic metastases
2. Previous received systemic therapy for liver cancer;
3. History of radiotherapy to the liver;
4. Indistinct tumor boundary on CT/MRI images;
5. 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];
6. 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;
7. Concurrent uncontrolled medical conditions;
8. Pregnancy or breast feeding;
9. Investigational drug therapy outside of this trial during or within 4 weeks of study entry;
10. Psychiatric or medical unstable conditions that compromise the patient's ability to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of maintenance Sorafenib.	twelve months

Secondary Outcome Measures

Name	Time	Method
Time to progression (TTP), progression-free survival (PFS) and overall survival (OS)	30 months

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China