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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00493402
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with minimal height of 150cm and minimal weight of 50 KG
* Histological confirmed HCC
* with no previous treatment
* With unresectable tumor
* With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
* No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
* No significant renal impairment (creatinine clearance \< 30 mL/minute)
* The following laboratory parameters:
* Platelet count ≥ 60,000/µL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 1.5 mg/dL
* ASL and AST ≤ 5 x upper limit of normal
* Serum albumin ≥ 35 g/L
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or a Pt/PTT within normal limits
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
* Avascular tumor
* Main portal vein obstruction without cavernous transformation
* Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
* Obstructive jaundice
* Severe underlying cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or breast-feeding patients.
* History of organ allograft
* Active clinically serious infections
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00493402
Study Brief:
Protocol Section:
NCT00493402