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:
NCT01817205
Eligibility Criteria:
Inclusion Criteria:
Patient factor
* Age between 18 and 75
* Child-Pugh A cirrhosis
* Eastern Cooperative Oncology Group(ECOG) performance status Grade 2 or below
* No serious concurrent medical illness
* Prior treatment for HCC including surgery, local ablation, or transarterial treatments allowed
* Imaging evidence of poor intralesional treatment response or disease progression despite transarterial treatment
* Platelet count ≥ 50 10\^9/L
Tumor factor
* HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
* Unresectable and locally advanced disease without extra-hepatic disease
* Hypervascular lesions on CT
* Greatest dimension of the largest tumor ≤15cm
Exclusion Criteria:
Patient factor
* History of significant concurrent medical illness such as ischemic heart disease or heart failure
* Metallic body implants, not including dental fillings
* Serum creatinine level \> 130 umol/L
* Presence of biliary obstruction not amenable to drainage
* Child-Pugh B or C cirrhosis
* Unable to give consent
Evidence of impaired liver function
* History of hepatic encephalopathy
* Intractable ascites not controllable by medical therapy
* History of variceal bleeding within last 3 months
* Serum total bilirubin level \>25 umol/L for the first 5 patients, serum total bilirubin level \>35 umol/L for the second 5 patients
* Serum albumin level \< 30g/L
* International normalized ratio(INR) \>1.3
Tumor factor
* Presence of extrahepatic metastasis
* Infiltrative lesion
Vascular invasion
* Hepatic artery thrombosis
* Partial or complete thrombosis of the main portal vein
* Tumor invasion of portal branch of contralateral lobe
* Hepatic vein tumor thrombus
* Significant arterioportal shunt
* Significant arteriovenous shunt
Contraindication for hyperthermia
* Known brain metastasis
* Recent stroke or cerebral hemorrhage within last 6 months
* Poorly controlled epilepsy
* Poorly controlled cardiac arrhythmias
* Myocardial infarction within last 6 months
* Unstable angina within last 6 months
* Poorly controlled hypertension
* Poorly controlled diabetes
* History of malignant hyperthermia
* Photodermatosis
* Pregnancy
* Lactation
* Serious infection
* Grade 3 or above adverse event in serological total bilirubin or albumin according to Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events
* Elevation of serum alanine transaminase ≥ 10 times upper limit of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01817205
Study Brief:
Protocol Section:
NCT01817205