Status:
COMPLETED
Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients
Lead Sponsor:
Samsung Medical Center
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
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 tyrosi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 13 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01481805
Start Date
January 14 2010
End Date
August 13 2014
Last Update
April 26 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung medical Center
Seoul, South Korea