Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00813293
Other study ID # 08-256
Secondary ID K23CA139005IST00
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2009
Est. completion date November 2013

Study information

Verified date June 2023
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to determine if sorafenib improves the effectiveness of a procedure called radiofrequency ablation (RFA) for the treatment of hepatocellular cancer (HCC). Radiofrequency ablation has been used to treat many types of tumors, including hepatocellular cancers. During RFA a needle is inserted into the tumor tissue and heat is used to kill the tumor cells. Sorafenib has been approved by the FDA for the treatment of hepatocellular cancer that cannot be treated with surgery. Pre-clinical data suggests that sorafenib may improve the efficacy of RFA.


Description:

Hepatocellular cancer (HCC) has a poor prognosis with increasing mortality in the United States. Because HCC generally develops in patients with underlying liver disease, resection is often not possible. Liver transplant improves survival for HCC patients but given the national organ donor shortage often patients have to wait a considerable time for transplant. Liver-directed therapies such as radiofrequency ablation (RFA) remain important tools to control tumor growth and to potentially "bridge" patients to liver transplant. However, liver-directed therapies for HCC tumors greater than 3cm in size are suboptimal, leaving a critical unmet need. Antiangiogenic systemic agents, such as oral sorafenib, reduce tumor blood flow and have been shown to improve RFA efficacy in animal and in computer models.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed hepatocellular cancer (HCC) by pathology or by NCCN imaging guidelines - All HCC stages are allowed. May be a liver transplant candidate. - At least one tumor (index tumor) accurately measured as 3.5-7cm in diameter (long and short axis diameter to be recorded, but only one needs to meet this criteria) on baseline imaging. - No prior therapy for the index tumor - No prior systemic treatment for HCC within 4 weeks and no prior anti-VEGF therapy within 8 weeks of study entry. - Life expectancy > 8 weeks. - ECOG >=0 or 1 - RFA clinically indicated for index tumor. - Acceptable overall RFA and anesthesia risk. - Adequate bone marrow, liver and renal function: Hemoglobin >9.0 g/dl; Absolute neutrophil count (ANC)>1,500/mm3; Platelet count correctable to >50,000/mm3; compensated liver function (Child-Turcotte-Pugh A, B7 or B8); Creatinine <1.5 times ULN; INR correctable to <1.5. - Ability to take oral medication and no evidence of impaired absorption. Exclusion Criteria - Urgent treatment of the index tumor anticipated. - Participants who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Participants currently receiving any other study agents. - Known brain metastases - History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib. - Participants receiving medications or substances that are inducers of CYP3A4 (rifampicin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone) or that are metabolized/eliminated by predominantly UGT1A1 pathway or by CYP2B6 and CYP2C8. - Decompensated liver disease - Uncontrolled hypertension - Thrombolic or embolic events within the past 6 months. - Hemorrhage/bleeding event within 4 weeks - Serious non-healing wound, ulcer, or bone fracture. - Evidence of severe or uncorrectable bleeding diathesis or coagulopathy - Major surgery, open biopsy or significant traumatic injury within 4 weeks of study entry. - Contraindication to or inability to undergo the RFA procedure, - Contraindication to or inability to undergo imaging with MRI - Uncontrolled intercurrent illness - Individuals with a history of a different malignancy unless disease-free for at least 5 years and are deemed by the Investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. - HIV-positive individuals on combination antiretroviral therapy For additional inclusion/exclusion criteria details contact Study Site.

Study Design


Intervention

Drug:
Sorafenib

Procedure:
radiofrequency ablation


Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts

Sponsors (6)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Bayer, Brigham and Women's Hospital, Dana-Farber Cancer Institute, National Cancer Institute (NCI), Onyx Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hakime A, Hines-Peralta A, Peddi H, Atkins MB, Sukhatme VP, Signoretti S, Regan M, Goldberg SN. Combination of radiofrequency ablation with antiangiogenic therapy for tumor ablation efficacy: study in mice. Radiology. 2007 Aug;244(2):464-70. doi: 10.1148/radiol.2442061005. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Coagulation Zone Diameter-Short Axis The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor. Up to day 50 from study enrollment (target 30 days after RFA)
Primary Coagulation Zone Diameter-Long Axis The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor. Up to day 50 from study enrollment (target 30 days after RFA)
Primary Coagulation Zone Volume The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor. Up to day 50 from study enrollment (target 30 days after RFA)
Secondary Feasibility Rate Feasibility rate is defined as the percentage of participants completing radiofrequency ablation following 9 days of sorafenib or placebo therapy. Up to day 14 since enrollment
Secondary Number of Treatment-Related Grade 1-4 Adverse Events (AEs) by Day 9 AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related up to day 9 of study drug treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple different AE types within a grade. Day 9
Secondary Number of Treatment-Related Grade 1-4 Adverse Events (AEs) on Day of Radiofrequency Ablation (RFA) AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related on day of RFA treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple AE types within a grade. Up to day 14 (target day 10 RFA)
Secondary Number of Treatment-Related Grade 1-4 Adverse Events (AEs) One Month After Radiofrequency Ablation (RFA) AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related one month after RFA treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple AE types within a grade. Up to day 40 post RFA (target 30 days)
See also
  Status Clinical Trial Phase
Recruiting NCT03971201 - A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion Phase 2
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Recruiting NCT05489250 - The PLATON Network
Completed NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer Phase 2
Terminated NCT00878215 - Clinical Application of Image-Guided Liver Surgery Phase 2
Completed NCT04212286 - Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC N/A
Recruiting NCT05992220 - Atezolizumab Plus Bevacizumab Alone or Combined With External Beam Radiotherapy for HCC With Macrovascular Invasion Phase 2
Completed NCT02073435 - A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation
Active, not recruiting NCT01522937 - A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer Phase 2
Terminated NCT05061537 - Study of PF-07263689 in Participants With Selected Advanced Solid Tumors Phase 1
Active, not recruiting NCT04166240 - Measuring and Improving the Safety of Test Result Follow-Up N/A
Withdrawn NCT02288507 - Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer Phase 1
Terminated NCT03026803 - A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer Phase 2
Active, not recruiting NCT04682847 - Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers
Active, not recruiting NCT05100082 - Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma
Active, not recruiting NCT03195699 - Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers Phase 1
Completed NCT02616692 - HCC Patient Preferences in Japan N/A
Active, not recruiting NCT03132792 - AFPᶜ³³²T in Advanced HCC Phase 1
Recruiting NCT01849588 - Sorafenib for Hepatocellular Cancer With Chronic Hepatitis C Phase 4
Completed NCT00997022 - Trial of Sorafenib in Hepatocellular Cancer (HCC) Transplant Patients Phase 1