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
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Sorafenib
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • The safety and tolerability of maintenance Sorafenib. [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression (TTP), progression-free survival (PFS) and overall survival (OS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999843

Contacts
Contact: Jian-dong Zhao, M.D. 862164175590 ext 1504 neilzhaojiandong@gmail.com

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Guo-liang Jiang, M.D. Fudan University
  More Information

No publications provided by Fudan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guo-liang Jiang M.D., Fudan University Shanghai Cancer Center
ClinicalTrials.gov Identifier: NCT00999843     History of Changes
Other Study ID Numbers: LCR-004
Study First Received: October 21, 2009
Last Updated: October 21, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Sorafenib
Three-dimensional conformal radiation therapy
Intensity-modulated radiation therapy
Transcatheter arterial chemoembolization

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014