Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01481805
First received: November 16, 2011
Last updated: May 12, 2014
Last verified: May 2014
  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: December 2014 (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
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: NCT01481805

Locations
Korea, Republic of
Samsung medical Center
Seoul, Korea, Republic of
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: May 12, 2014
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 July 29, 2014