Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

Inclusion Criteria

• •Participant must have histologically or cytologically confirmed metastatic colorectal adenocarcinoma. There must be previous documentation of RAS (Rat sarcoma mutation), BRAF (B-Raf proto-oncogene, Serine/threonine kinase), MSI/MMR (microsatellite instability, mismatch repair) , and HER2 (Human epidermal growth factor receptor 2) status.
• •Participant must have progressed on or been intolerant to the following previous treatments (if not contraindicated):
• •* Fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy
• •* Anti-VEGF (vascular endothelial growth factor) biological therapy, such as bevacizumab, aflibercept, or ramucirumab
• •* If RAS is wild type, an anti-EGFR (epidermal growth factor receptor) therapy like cetuximab or panitumumab
• •Participant must have evaluable disease as defined by the investigator using CT (computed tomography), MRI (magnetic resonance imaging), or PET (positron emission tomograph) scan.
• •Participant must have a body weight ≥ 40 kg.
• •Participant must be aged 22 years or older.
• •Participant must be able to understand a written informed consent document and be willing to sign it.
• •Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• •Participant must have adequate organ and marrow function within 14 days prior to the initiation of treatment as described below:
• •Participant should have an expected lifespan of \>12 weeks as determined by the investigator.
• •Fruquintinib is suspected to cause loss of human pregnancy and impaired development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner starting at initiation of treatment up until at least 14 days after the last fruquintinib dose.
• •Participants with clinically uncontrolled active infections requiring intravenous antibiotics.
• •Participants with tumor invasion of a large vascular structure (e.g., pulmonary artery, superior or inferior vena cava).
• •Participants with brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy and without clinical imaging evidence of stable disease for 14 days or longer.
• •Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints.
• •Participants that are unable to take medication orally including those with dysphagia or an active gastric ulcer resulting from previous surgery (e.g., gastric bypass) or severe gastrointestinal disease, or any other condition that the investigator believes may affect absorption of fruquintinib.
• •Participants with metabolic disorder that the investigator suspects may prohibit fruquintinib action, affect interpretation of study results, or put the participant at undue risk of harm based on the investigator's assessment.
• •Participants that have received prior fruquintinib treatment.
• •Participants with a known hypersensitivity to fruquintinib or any of its inactive ingredients including the azo dyes tartrazine, FD\&C yellow 5, and sunset yellow FCF.
• •Participants taking strong inducers or inhibitors of CYP3A4 within five half-lives or four weeks, whichever is longer, before the first dose of study drug. Refer to Appendix 2 for a comprehensive list of excluded medications related to CYP3A4.
• •Participants that are taking any other investigational drugs.
• •Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).
• •Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid/vitamin C, etc.) unless these drugs are discontinued at least 7 days prior to starting TheraBionic P1 device treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study. Refer to Appendix 3 for a comprehensive list of excluded medications related to calcium channels.
• •Participants that are pregnant or breastfeeding are ineligible for this study. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued.
• •Participants who have received a live vaccine ≤ 28 days before the first dose of fruquintinib. (Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.)
• •Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.