Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Sponsor Samsung Medical Center
Start date August 2008
End date December 2014
Trial size 100 participants
Trial identifier NCT01481805, 2009-09-055

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm

Primary Outcomes

Measure
Biomarkers predictive
time frame: 36months

Secondary Outcomes

Measure
Signal transduction pathway
time frame: 36months
The RTK activation status.
time frame: 36months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Samsung Medical Center.