Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

April 24, 2017 updated by: Ho Yeong Lim, Samsung Medical Center

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hepatocellular carcinoma patients treated with sorafenib

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Hepatocellular carcinoma patients treated with sorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal transduction pathway
Time Frame: 36months
To elucidate signal transduction pathway attributable to sorafenib resistance.
36months
The RTK activation status.
Time Frame: 36months
To monitor changes in the RTK activation status during sorafenib treatment using circulating tumor cells.
36months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2010

Primary Completion (Actual)

January 13, 2014

Study Completion (Actual)

August 13, 2014

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

November 27, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-09-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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