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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT02821533
Eligibility Criteria:
Inclusion Criteria:
Patient factor
1. Age \> 18
2. Child-Pugh A or B cirrhosis
3. ECOG performance status Grade 2 or below
4. No serious concurrent medical illness
5. No prior treatment for HCC except for liver resection
6. Creatinine clearance \>55ml/min.
Tumor factor
1. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
2. Unresectable and locally advanced disease without extra-hepatic disease
3. Massive expansive tumor type with measurable lesion on CT
4. Total tumor mass \< 50% liver volume
5. Largest tumor of greatest dimension ≤ 15cm
Exclusion Criteria:
Patient factor
1. Serum creatinine level \> 130 umol/L
2. Presence of biliary obstruction not amenable to percutaneous drainage
3. Child-Pugh C cirrhosis
Evidence of impaired liver function
1. History of hepatic encephalopathy, or
2. Intractable ascites not controllable by medical therapy, or
3. History of variceal bleeding within last 3 months, or
4. Serum total bilirubin level \> 40 umol/L, or
5. Serum albumin level \< 30g/L, or
6. INR \> 1.3
Tumor factor
1. Presence of extrahepatic metastasis
2. Infiltrative lesion
3. Diffuse lesion
Vascular complications
1. Hepatic artery thrombosis, or
2. Partial or complete thrombosis of the main portal vein, or
3. Tumor invasion of portal branch of contralateral lobe, or
4. Hepatic vein tumor thrombus, or
5. Significant arterioportal shunt, or
6. Significant arteriovenous shunt
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02821533
Study Brief:
Protocol Section:
NCT02821533