Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01481805
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01481805
Study Brief:
Protocol Section:
NCT01481805