Clinical trial NCT04526080: Intrabucally Administered Electromagnetic Fields Versus Placebo as Third-line Therapy For Patients With Advanced Hepatocellular Carcinoma
Official title: A Randomized Phase II Study Of Intrabucally Administered Electromagnetic Fields Versus Placebo as Third-line Therapy For Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to gather efficacy data concerning overall survival with electromagnetic field when compared to a placebo amplitude-modulated radiofrequency electromagnetic field device in subjects who have failed or are intolerant to at least two previous systemic therapies

Detailed description: Primary Objective: To estimate overall survival.

Secondary Objectives

* To estimate progression-free survival.
* 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 that is locally advanced or metastatic
* Patients must have measurable disease.
* Failure or intolerance to prior treatments with at least two different approved or experimental systemic therapies including sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilumab, atezolizumab and bevacizumab, or any approved or experimental first line and/or second line therapy that did not include the TheraBionic device (defined as documented radiological progression according to the radiology charter). Randomization needs to be performed within 10 weeks after the last systemic treatment
* Measurable disease according to 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, TACE, hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed by 20% or more according to mRECIST for hepatocellular carcinoma.
* Patients with Child's Pugh A or B (at time of enrollment) as defined by the parameters contained in the Child Pugh Calculator.-Subjects with Child's Pugh score of B8-B9 may be included if they have: Albumin \> 2.8 mg/l AND Total Bilirubin \< 3.0mg/l, Performance status ECOG 0-2.
* Patient must not have curative treatment options, including surgery or radiofrequency ablation, available as assessed by their physician.
* Any extra-hepatic metastases, including treated CNS metastases but patients cannot have leptomeningeal disease.
* At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
* Other anti-cancer treatments are not permitted during this study
* Patients must be more than 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 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
* Has received treatment for other carcinomas within the last three years except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or stage I breast cancer, non-invasive bladder cancer, or treated in-situ cervical cancer).
* Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels, e.g. amlodipine, nifedipine, ethosuximide, ascorbic acid (vitamin C), etc. are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.

Primary outcomes:
measure: Overall Survival
timeFrame: 6 months
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: Up to 2 years
measure: Proportion of Patients Progression Free After 12 weeks
timeFrame: 12 weeks, 4 months and 6 months
measure: Number of Adverse Events
timeFrame: Up to 28 days after last study treatment administration
measure: Changes in Alfa-Fetoprotein Levels
timeFrame: 6 months
measure: Response Rates
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
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: William Blackstock, MD
role: PRINCIPAL_INVESTIGATOR
References: