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Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma

Phase 2
18 Years
69 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local recurrence, defined as the recurrence at the size of original tumor

Outcome Description:

Local recurrence will be summarized using descriptive statistics.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Steven Strasberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

May 2013

Completion Date:

December 2018

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular



Washington University School of Medicine Saint Louis, Missouri  63110