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

NCT ID: NCT00999843

Last Updated: 2009-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Fudan University Shanghai Cancer Center

Principal Investigators

Guo-liang Jiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian-dong Zhao, M.D.

Role: CONTACT

neilzhaojiandong@gmail.com

862164175590 ext. 1504

References

Zhao JD, Liu J, Ren ZG, Gu K, Zhou ZH, Li WT, Chen Z, Xu ZY, Liu LM, Jiang GL. 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. Radiat Oncol. 2010 Feb 12;5:12. doi: 10.1186/1748-717X-5-12.

Reference Type: DERIVED

PMID: 20149262 (View on PubMed)

Other Identifiers

LCR-004

Identifier Type: -

Identifier Source: org_study_id