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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT01259193
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
* patient with unresectable primary hepatocellular carcinoma
* Child-Pugh Class A or B, score ≤ 7
* ECOG score 0-2
* Expected survival time not less than 12 weeks
* At least one tumor nodule with one uni-dimension of ≥ 1 cm
* Peripheral platelet of or more than 50×10(9)/L
* Peripheral hemoglobin of or more than 85g/L
* Peripheral albumen of or more than 28g/L
* Total bilirubin ≤3.0mg/dl
* ALT and AST ≤ 5.0 x the upper limit of normal
* Serum amylase ≤ 1.5x the upper limit of normal
* Serum creatinine ≤ 1.5x upper limit of normal
* PT-INR\<2.3 or PT prolong no more than 4s of normal
Exclusion Criteria:
* Congestive heart failure \> NYHA class 2
* History of active coronary disease( except myocardial infarction more than 6 months ago)
* Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
* uncontrollable hypertension
* Active clinically serious infections (\> 2 NCI-CTC Version 3.0)
* History of HIV infection
* Inclined to hemorrhage or active hemorrhage with 1 month
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
* Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
* Known or suspected allergy to any agent given in association with this trial
* Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
* Surgical operation within 4 weeks prior to enrolling in this portion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01259193
Study Brief:
Protocol Section:
NCT01259193