Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

NCT ID: NCT01481805

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-14
• Study Completion Date: 2014-08-13

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Hepatocellular carcinoma patients treated with sorafenib

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ho Yeong Lim

Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2009-09-055

Identifier Type: -

Identifier Source: org_study_id