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Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01481805
First Posted: November 30, 2011
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center
  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 Ho Yeong Lim, Samsung Medical Center:

Primary Outcome Measures:
  • Biomarkers predictive [ Time Frame: 36months ]
    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 ]
    To elucidate signal transduction pathway attributable to sorafenib resistance.

  • The RTK activation status. [ Time Frame: 36months ]
    To monitor changes in the RTK activation status during sorafenib treatment using circulating tumor cells.


Enrollment: 100
Actual Study Start Date: January 14, 2010
Study Completion Date: August 13, 2014
Primary Completion Date: January 13, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hepatocellular carcinoma patients treated with sorafenib

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481805


Locations
Korea, Republic of
Samsung medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
  More Information

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
First Submitted: November 16, 2011
First Posted: November 30, 2011
Last Update Posted: April 26, 2017
Last Verified: April 2017

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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action