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:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT01669668
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven HCC or unambiguous radiologic findings consistent with HCC (\> 1 cm tumor with arterial hypervascularity and venous or delayed phase washout) in patients with underlying liver disease.
* Disease must be considered unresectable (as defined by protocol).
* Age between 18 and 69 (inclusive).
* Karnofsky performance status of ≥ 80%
* Normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* platelets \>100,000/mcL
* total bilirubin \<2.0 mg/dL
* AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* Presence of ≤ 3 tumors, all of which are ≤ 3 cm in size. This will be determined preoperatively and confirmed by intraoperative ultrasound.
* Liver function of Child-Pugh class A or B
* Tumor(s) must be more than 2 cm away from of major biliary duct or major blood vessel defined as the main portal vein and its right and left primary branches and the first 1 cm of the secondary branches of the common hepatic duct and its right and left primary branches or the first 1 cm of its secondary branches.
* Able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
* Hepatic tumor(s) with satellite lesions. A satellite lesion is defined as a tumor which is within 2 cm of the tumor being assessed for treatment and which has a diameter of less than 33% of the diameter of the tumor being assessed for treatment.
* Evidence of metastatic/extrahepatic disease based on abdominal and chest CT performed within 4 weeks of the procedure.
* Extrahepatic disease upon laparoscopy performed at the time of RFA. If extrahepatic disease is discovered at this laparoscopy, RFA will not be performed, and the patient will be considered ineligible for this study and will be replaced.
* Pregnancy. All women of childbearing potential must have a negative pregnancy test prior to enrollment in the study.
* Significant portal hypertension based on evidence of esophageal varices or ascites. Minimal portal hypertension or ascites will not be an exclusion criterion.
* Previous history of HCC or any other non-cutaneous malignancy.
Patients who are found to be ineligible due to intraoperative findings will be recorded as to the cause of ineligibility. They will not be counted as accrued patients.
-Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01669668
Study Brief:
Protocol Section:
NCT01669668