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

Hepatocellular Carcinoma Clinical Trial

Official title:

Maintenance of Sorafenib Following Combined Therapy of Three-dimensional Conformal Radiation Therapy/Intensity-modulated Radiation Therapy and Transcatheter Arterial Chemoembolization in Patients With Locally Advanced Hepatocellular Carcinoma: a Phase I/II Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00999843
• Other study ID #: LCR-004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 21, 2009
• Last updated: October 21, 2009
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: October 2009
• Source: Fudan University
• Contact: Jian-dong Zhao, M.D.
• Phone: 862164175590
• Email: neilzhaojiandong[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib
Sorafenib is administered only to the patients with non-progression disease (CR, PR and SD) 4 weeks after the completion of radiotherapy. The dose is 400 mg, p.o., twice a day. Sorafenib is continuously given for 12 months unless intolerable toxicities and/or tumor progression.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and tolerability of maintenance Sorafenib.		twelve months	Yes
Secondary	Time to progression (TTP), progression-free survival (PFS) and overall survival (OS)		30 months	No