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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00990860
Eligibility Criteria:
Inclusion Criteria:
* Age ≧ 18
* life expectancy \> 12 weeks
* Histologically diagnosed HCC, OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis. A clinically diagnosed HCC should fulfill ALL the criteria below
* Chronic hepatitis B or C and/or evidence of liver cirrhosis.
* Presence of hepatic tumour(s) with image findings compatible with HCC, and no evidence of other gastrointestinal tumours
* A persistent elevation of serum AFP \>= 400 ng/ml without any evidence of an existing α-fetoprotein-secreting germ cell tumour
* Child-Pugh score ≦ 7
* BCLC B
* The patient must have a solitary hepatic tumour greater than 3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning.
* The target lesion must not have been previously treated with local therapy
* The patient must not be a candidate for surgical resection or ablation of the tumour. Size of largest tumor ≦10cm in largest dimension
* Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible
* Local therapy must have been completed at least 4 weeks prior to baseline scan.
* ECOG performance status 0 or 1
* Hb ≧ 9g/dL,
* Absolute neutrophil count \> 1000/mm3
* Platelet count ≧ 60x109/L
* Adequate clotting function: INR \< 1.5
* Hepatic: AST or ALT \< 5 X ULN
* Renal: serum creatinine \< 1.5 x ULN
* Bilirubin ≦ 3mg/dL
* The patient must give written, informed consent
Exclusion Criteria:
* Tumor factors
* Presence of extrahepatic metastasis
* Predominantly infiltrative lesion
* Diffuse tumor morphology with extensive lesions involving both lobes.
* Vascular complications
* Hepatic artery thrombosis, or
* Partial or complete thrombosis of the main portal vein, or
* Tumor invasion of portal branch of contralateral lobe, or
* Hepatic vein tumor thrombus, or
* Significant arterioportal shunt not amenable to shunt blockage
* Liver function
* Advanced liver disease: ascites, hepatic encephalopathy
* Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry.
* Others
* Pregnant or lactating women.
* Active sepsis or bleeding.
* Hypersensitivity to intravenous contrast agents.
* The patient has received prior treatment for HCC target lesion.
* History of cardiac disease
* Congestive heart failure \> NYHA class 2; active coronary artery disease
* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
* Hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management.
* Therapeutic anticoagulation with coumarin, heparins, or heparinoids.
* Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months.
* Impairment of swallowing that would preclude administration of sorafenib.
* The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions.
* Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted
* Any active clinically serious infections (\> grade 2 NCI-CTCAE ver 3.0)
* HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00990860
Study Brief:
Protocol Section:
NCT00990860