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Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Biomarkers predictive

Outcome Description:

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

Outcome Time Frame:


Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular