Clinical trial · Interventional
Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
NCT00132041CI-TRIAL-00047074ACRIN-6673completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment for liver cancer and cirrhosis. PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiofrequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All Patients
- description
- patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.
- interventionNames
- Device: radiofrequency ablation
Primary outcomes (1)
- measure
- Proportion of Participants With Successful Control of Disease at 18 Months
- timeFrame
- 18 months after start of therapy
- description
- Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months.
Secondary outcomes (7)
- measure
- Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of hepatocellular carcinoma (HCC), meeting 1 of the following criteria:
* Histologically confirmed HCC
* Discrete non-biopsied hepatic tumors, meeting 1 of the following criteria:
* Hypervascular tumor \> 2 cm by 2 imaging studies
* Hypervascular tumor \> 2 cm by a single imaging study AND alpha-fetoprotein ≥ 400 ng/mL
* Discrete non-biopsied hypervascular hepatic tumors by 2 consecutive imaging studies (e.g., CT scan or MRI) with documented tumor growth \> 1 cm in diameter
* Histologically confirmed cirrhosis OR typical findings of cirrhosis (i.e., nodular liver, splenomegaly, varices, or ascites) by CT scan and/or MRI scan
* Single hepatic tumor \> 3.0 cm but ≤ 5.0 cm in diameter OR 3 or fewer hepatic tumors ≤ 3.0 cm in diameter
* No excessive intrahepatic tumor burden (i.e., \> 3 hepatic tumors OR a single hepatic tumor \> 5 cm OR more than 3 vague hypervascular nodules \> 1 cm)
* Tumor(s) ≥ 1 cm from the main, right, and left portal veins and hollow viscera
* No hepatic or portal vein tumor invasion
* Tumor(s) \> 1 cm treatable by percutaneous radiofrequency ablation
* No extrahepatic tumor
* Not a surgical candidate due to any of the following reasons:
* Tumor in an unresectable location
* Comorbid disease
* Insufficient hepatic reserve
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* No uncorrectable coagulopathy
Hepatic
* Not specified
Renal
* Creatinine ≤ 2.0 mg/dL
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active symptomatic bacterial or fungal infection that is newly diagnosed and/or requires treatment
* No absolute contraindication to IV iodinated contrast (i.e., history of significant contrast reaction not mitigated by appropriate premedication)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior or concurrent chemotherapy for HCC
* No prior or concurrent chemoembolization for HCC
Endocrine therapy
* Not specified
Radiotherapy
* No prior or concurrent radiotherapy for HCC
Surgery
* No prior choledochoenteric anastomosis
* No prior sphincterotomy of duodenal papilla
Other
* No prior or concurrent cryoablation for HCC
* No other prior or concurrent therapy for HCC
* At least 7 days since prior aspirin
* At least 24 hours since prior ibuprofen
* At least 12 hours since prior low molecular weight heparin preparationsReferences
Publications (0)
Data not yet available
No reference posted for this study.