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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00999843
First received: October 21, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 21, 2009
October 21, 2009
October 2009
October 2010   (final data collection date for primary outcome measure)
The safety and tolerability of maintenance Sorafenib. [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Time to progression (TTP), progression-free survival (PFS) and overall survival (OS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Sorafenib Following Combined Therapy of Radiation and TACE for Liver Cancer
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.

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
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.
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2012
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Jian-dong Zhao, M.D. 862164175590 ext 1504 neilzhaojiandong@gmail.com
China
 
NCT00999843
LCR-004
Yes
Guo-liang Jiang M.D., Fudan University Shanghai Cancer Center
Fudan University
Not Provided
Principal Investigator: Guo-liang Jiang, M.D. Fudan University
Fudan University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP