Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01481805
First received: November 16, 2011
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

To explore biomarkers predictive of clinical response to sorafenib in unresectable hepatocellular carcinoma using the Prometheus Platform To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells.

To identify negative predictive markers to sorafenib. To elucidate signal transduction pathway attributable to sorafenib resistance. To monitor changes in the RTK activation status during sorafenib treatment using circulating tumor cells.

To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to sorafenib.


Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Biomarkers predictive [ Time Frame: 36months ] [ Designated as safety issue: No ]
    To explore biomarkers predictive of clinical response to sorafenib in unresectable hepatocellular carcinoma using the Prometheus Platform A. To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells B. To identify negative predictive markers to sorafenib


Secondary Outcome Measures:
  • Signal transduction pathway [ Time Frame: 36months ] [ Designated as safety issue: No ]
    To elucidate signal transduction pathway attributable to sorafenib resistance.

  • The RTK activation status. [ Time Frame: 36months ] [ Designated as safety issue: No ]
    To monitor changes in the RTK activation status during sorafenib treatment using circulating tumor cells.


Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hepatocellular carcinoma patients treated with sorafenib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hepatocellular carcinoma patients treated with sorafenib

Criteria

Inclusion Criteria:

  • Patients with histologically confirmed hepatocellular carcinoma (HCC) or a combination of radiologically compatible finding to HCC, alpha-fetoprotein > 400ng/mL and liver cirrhosis
  • Inoperable disease as defined by (Localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin OR Presence of extra-hepatic disease OR Main portal vein or hepatic vein involvement (invasion or tumor thrombus) OR The HCC must not be amenable to intra-arterial therapy or local ablative therapy)
  • Minimum life expectancy of 12 weeks
  • Age > 18 years.
  • ECOG Performance Status of ≤ 2
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

(Hemoglobin > 9.0 g/dl,Absolute neutrophil count>1,500/mm3, Platelet count>75,000/μl,Total bilirubin < 1.5 times the upper limit of normal,ALT and AST < 5 x upper limit of normal,Albumin ≥ 3g/dL,PT-INR/PTT < 1.5 x upper limit of normal,Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥ 50mL/min)

  • Signed and dated informed consent before the start of specific protocol procedures.
  • FNA will be performed in patients with feasible biopsy site

Exclusion Criteria:

  • Decompensated cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification
  • Other concomitant anticancer agent, including Tamoxifen and Interferon
  • Active clinically serious infections (> grade 2 CTCAE version 3.0)
  • History of organ allograft
  • Patients with evidence or history of bleeding diasthesis
  • Patients undergoing renal dialysis
  • Radiotherapy during study or within 4 weeks of start of study drug.
  • Prior exposure to the study drug.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481805

Contacts
Contact: mi yeon Kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung medical Center Recruiting
Seoul, Korea, Republic of
Contact: mi yeon kwon, RN    +82-2-3410-1248    miyeon.kwon@samsung.com   
Principal Investigator: Ho Yeong Lim, MD         
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Ho Yeong Lim, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01481805     History of Changes
Other Study ID Numbers: 2009-09-055
Study First Received: November 16, 2011
Last Updated: February 22, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014