Clinical trial NCT04327700: Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib
Official title: A Phase II Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib as Second-line Therapy For Patients With Advanced Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: THERABIONIC INC.
First posted: 2020-03-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Primary Objective: To estimate progression-free survival rates.

Secondary Objectives

* To obtain information concerning the feasibility of administration of the proposed treatment, including patient participation in trials using the proposed treatment.
* To evaluate safety and tolerability in this patient population.
* To evaluate the effect on levels of alpha-fetoprotein.

Eligibility criteria: 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 cirrhosis, as defined by the parameters contained in the Child Pugh Calculator found in Appendix E.
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
* Absence of medical or psychiatric contraindication which, in the opinion of the treating Investigator, would make the patient's participation in this trial inappropriate.
* Patient must not have curative treatment options, including surgery or radiofrequency ablation, available.
* Any extra-hepatic metastases, including treated central nervous system metastases but patients cannot have leptomeningeal disease.
* At least 2 weeks must have elapsed since administration of any anti-cancer treatment.
* Other anti-cancer treatments are not permitted during this study, including alternative medicine and herbal therapies.
* Patients must be 18+ years old and must be able to understand and sign an informed consent.
* Patient must agree to be followed up according to the study protocol.

Exclusion Criteria:

* Known leptomeningeal disease.
* Fibro lamellar hepatocellular carcinoma.
* Patients who had surgical resection of the disease and who do not have measurable disease.
* Patients with any of the following history within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
* Pregnant or breastfeeding women.
* Patients diagnosed with another type of cancer (excluding basal cell carcinoma) whose cancer diagnosed previously is not in remission.
* Patients receiving calcium channel blockers and any agent blocking L-type or T-type Voltage Gated Calcium Channels, e.g. amlodipoine, nifedipine, ethosuximide, etc. are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.
* Patients allergic or intolerant to Sorafenib.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: 6 months
measure: Percentage of Participants with Disease Control
timeFrame: At 4 months and at 6 months from the date of enrollment
measure: Incidences of Adverse Events
timeFrame: Up to 30 days after treatment ends
measure: Comparison of Adverse Events (WFBCCC 55319 to RESORCE historical trial)
timeFrame: Up to 30 days after treatment ends
measure: Change in Alpha-fetoprotein Levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ravi Paluri, MD
role: PRINCIPAL_INVESTIGATOR
References: