Clinical trial NCT00999843: Safety Study of Sorafenib Following Combined Therapy of Radiation and TACE for Liver Cancer
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Sorafenib
Three-dimensional conformal radiation therapy
Intensity-modulated radiation therapy
Transcatheter arterial chemoembolization
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The safety and tolerability of maintenance Sorafenib.
timeFrame: twelve months
Secondary outcomes:
measure: Time to progression (TTP), progression-free survival (PFS) and overall survival (OS)
timeFrame: 30 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Guo-liang Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.