Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

NCT01481805 | Completed

• 1 other identifier: 2009-09-055
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Biomarkers predictive

  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 Outcomes (2)

• Signal transduction pathway

  36months

• The RTK activation status.

  36months

Study Arms (1)

Hepatocellular carcinoma patients treated with sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hepatocellular carcinoma patients treated with sorafenib

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 30, 2011
• Study Start: January 14, 2010
• Primary Completion: January 13, 2014
• Study Completion: August 13, 2014
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

KR (1)