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Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

NCT07130903•Barbara Ann Karmanos Cancer Institute

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to Fruquintinib in metastatic colorectal cancer that has not responded to other standard treatment is: * Effective in improving survival * safe and tolerable

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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.
+18 more criteria

Exclusion Criteria

•Participants with uncontrolled hypertension per investigator discretion.
•Participants with a history or presence of gastric/duodenal ulcer or ulcerative colitis, hemorrhage of an unresected gastrointestinal tumor, perforation, fistulas, or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation.
•Participants with a history or presence of hemorrhage from any other site (i.e., lower GI bleed, hemoptysis or hematemesis) within two months prior to screening.
•Participants with a history of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within three months prior to screening unless they are on a stable dose of anticoagulant and no further evidence of active thromboses are seen on CT scan or venous Doppler imaging. Participants with saddle (massive) pulmonary embolism that require thrombectomy/thrombolysis within 12 months of screening are excluded from the trial.
•Participants with a history of stroke and/or transient ischemic attack within 12 months prior to screening.
•Participants with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within six months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or previous left ventricular ejection fraction (LVEF) \< 50% by echocardiogram.
•Participants with corrected QT interval using the Fridericia method (QTcF) \> 480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative.
•Participants taking concomitant medications with a known risk of causing QT prolongation and/or torsades de pointes. (Source list is continuously updated online at www.crediblemeds.org.)
•Participants taking systemic anti-neoplastic therapies four weeks prior to the first dose of study drug, including chemotherapy, biotherapy, or immunotherapy. Palliative radiation is allowed if it does not cover all evaluable disease.
•Participants taking systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors) within five half-lives or four weeks, whichever is shorter, prior to the first dose of study drug.
+3 more criteria

Locations (9)

Karmanos Cancer Institute at McLaren Bay Region

Bay City, Michigan, United States

Karmanos Cancer Institute at McLaren Clarkston

Clarkston, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Karmanos Cancer Institute at McLaren Lapeer Region

Lapeer, Michigan, United States

Karmanos Cancer Institute at McLaren Macomb

Macomb, Michigan, United States

Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

Petoskey, Michigan, United States

Karmanos Cancer Institute at McLaren Port Huron

Port Huron, Michigan, United States

Key Dates

Start Date

September 10, 2025

Primary Completion Date

April 17, 2028

Completion Date

April 17, 2030

Last Updated

November 10, 2025

Enrollment

102

ESTIMATED participants

Conditions

Metastatic Colorectal Adenocarcinoma

Interventions

Fruquintinib

DRUG

TheraBionic P1

DEVICE

Contacts

Mohammed Najeeb Al Hallak, MD

CONTACT

13135768718 alhallakm@karmanos.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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