Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib (NCT04327700) | Clinical Trial Compass
TerminatedPhase 2
Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib
Stopped: Slow accruals
United States2 participantsStarted 2021-01-26
Plain-language summary
The primary goal of this study is to gather efficacy data concerning the progression-free survival rate with electromagnetic fields plus Regorafenib when compared to historical data with Regorafenib alone as a second-line therapy in patients with advanced hepatocellular carcinoma who have received any first line systemic therapy either standard of care Sorafenib or Lenvatinib or any experimental therapy. Patients who have received any treatment that includes either electromagnetic fields or Regorafenib will be excluded.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Biopsy-proven hepatocellular carcinoma is locally advanced or metastatic. OR
* Patients without biopsy confirmation are also eligible if they meet the following:
* Radiologic diagnosis of hepatocellular carcinoma as per the American Association for the Study of Liver Diseases (AASLD) guidelines:
* liver cirrhosis AND
* a liver mass confirmed by blinded independent central review that shows arterial phase hyperenhancement on triphasic CT or MRI, AND EITHER:
* Is ≥20 mm with either non-peripheral portal washout or an enhancing capsule
* OR is 10-19 mm with non-peripheral portal venous washout AND an enhancing capsule.
* Patient must have been treated with at least one standard systemic treatment modality for advanced hepatocellular carcinoma such as sorafenib, lenvatanib, atezolizumab plus bevacizumab, or another approved or experimental systemic therapy prior to study entry.
* Measurable disease according to RECIST version 1.1 and mRECIST for hepatocellular carcinoma.
* At least one target lesion should not have previously received any local therapy, such as surgery, radiation therapy, hepatic arterial embolization, transarterial chemoembolization (TACE), hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed by 20% or more according to RECIST version 1.1 and mRECIST for hepatocellular carcinoma.
* Patients with Child's Pugh A (at time of enrollment), with compensated cir…