Liver Cancer Clinical Trial
Official title:
Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
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.
OBJECTIVES:
Primary
- Determine the 18-month successful disease control rate, defined as no identifiable liver
tumor by CT scan, in patients with hepatocellular carcinoma and cirrhosis treated with
solitary or repetitive percutaneous radiofrequency ablation (RFA).
Secondary
- Correlate tumor size, MELD score, and the number of RFA treatments (solitary or
repetitive) with the 18-month successful disease control rate in patients treated with
this procedure.
- Determine the local and remote intrahepatic and extrahepatic tumor recurrence rates in
patients treated with this procedure.
- Correlate local and remote intrahepatic and extrahepatic tumor recurrence rates with the
18-month successful disease control rate in patients treated with this procedure.
- Correlate tumor size with the local disease control rate in patients treated with this
procedure.
- Correlate solitary or repetitive RFA with or without local/regional tumor control with
the development of extrahepatic tumor in these patients.
- Determine the local tumor eradication rate, as determined by examination of whole liver
specimens or CT scan, in patients treated with this procedure.
OUTLINE: This is a multicenter study. Patients are stratified according to hepatic
dysfunction using the MELD score (< 15 vs 15-25 vs > 25).
Patients undergo placement of an ablation electrode percutaneously into the tumor(s) by CT
scan, MRI, or ultrasound guidance. Patients then undergo percutaneous radiofrequency ablation
(RFA) directly to the tumor(s) for 12 minutes. Patients undergo CT scan of the liver within 1
week after RFA treatment and then every 3 months for up to 18 months. Patients with residual
or recurrent intrahepatic tumor(s) detectable on the 3-month or subsequent CT scan undergo
repeat RFA as is technically feasible and clinically indicated for up to 15 months after
initial RFA treatment.
After completion of study treatment, patients are followed at 1 day, 1 week, 1 month, and
then every 3 months for up to 18 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
| Recruiting |
NCT05160740 -
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
|
N/A | |
| Completed |
NCT01906021 -
Study of New Software Used During Ablations
|
N/A | |
| Terminated |
NCT04589884 -
Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
|
||
| Recruiting |
NCT05953337 -
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
|
N/A | |
| Enrolling by invitation |
NCT04466124 -
Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
|
||
| Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
| Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
| Completed |
NCT03059238 -
Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure
|
Phase 3 | |
| Recruiting |
NCT02632188 -
Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01388101 -
Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)
|
N/A | |
| Completed |
NCT01042041 -
Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer
|
Phase 1 | |
| Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
| Completed |
NCT00980239 -
HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver
|
Phase 1 | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| Completed |
NCT00543777 -
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
|
Phase 1/Phase 2 | |
| Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A |