Actively Recruiting
A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields Combined With Fruquintinib in Refractory Metastatic Colorectal Cancer
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-11-10
102
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Barbara Ann Karmanos Cancer Institute
Lead Sponsor
T
THERABIONIC INC.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) and Fruquintinib in adults with metastatic colorectal adenocarcinoma that has not responded to standard treatments. This Phase 2 study aims to determine if adding AM RF EMF to Fruquintinib improves survival while being safe and tolerable. The trial focuses on patients whose cancer has progressed despite previous therapies targeting RAS, BRAF, MSI/MMR, and HER2 markers. Participants receive treatment with the TheraBionic P1 device delivering AM RF EMF three times daily continuously, alongside daily doses of Fruquintinib taken orally in cycles of three weeks on treatment followed by one week off. This combined therapy is studied throughout the treatment period, with careful monitoring of safety and tolerability. Throughout the study, participants undergo regular assessments including imaging scans (CT, MRI, or PET) to evaluate disease status, and blood tests to measure biomarkers like carcinoembryonic antigen (CEA) and microRNA levels. Researchers will track overall survival up to five years post-treatment or until death. Safety is monitored during treatment and for 28 days after device discontinuation. The total participation duration varies as outcomes are followed long term.
CONDITIONS
Brief Title
Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have histologically or cytologically confirmed metastatic colorectal adenocarcinoma with documented RAS, BRAF, MSI/MMR, and HER2 status.
- Participant must have progressed on or been intolerant to prior treatments including fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy, anti-VEGF therapy, and if RAS wild type, anti-EGFR therapy.
- Participant must have evaluable disease by CT, MRI, or PET scan.
- Participant must weigh at least 40 kg.
- Participant must be aged 22 years or older.
- Participant must understand and be willing to sign informed consent.
- Participant must have an ECOG performance status of 0-2.
- Participant must have adequate organ and marrow function within 14 days prior to treatment.
- Participant should have an expected lifespan greater than 12 weeks.
- Women of child-bearing potential and male participants must agree to use effective contraception during treatment and for 14 days after last dose of Fruquintinib.
You will not qualify if you...
- Participants with uncontrolled hypertension.
- Participants with history or presence of gastric/duodenal ulcer, ulcerative colitis, gastrointestinal hemorrhage, perforation, fistulas, or other conditions risking GI hemorrhage or perforation.
- Participants with hemorrhage from any site within two months prior to screening.
- Participants with recent thromboembolic events within three months prior to screening or recent massive pulmonary embolism.
- Participants with stroke or transient ischemic attack within 12 months prior to screening.
- Participants with significant cardiovascular disease including recent heart attack, unstable angina, severe heart failure, arrhythmias, or low left ventricular ejection fraction.
- Participants with prolonged QTc interval or risk factors for arrhythmia.
- Participants taking medications that prolong QT interval.
- Participants using systemic anti-neoplastic therapies within four weeks prior to study drug.
- Participants using targeted therapies within five half-lives or four weeks prior.
- Participants with major surgery within 30 days prior to study drug or unhealed incision.
- Participants with unresolved toxicities greater than grade 2 from prior treatments.
- Participants with current drug or alcohol abuse.
- Participants with poorly controlled HIV or active viral hepatitis.
- Participants with uncontrolled active infections requiring IV antibiotics.
- Participants with tumor invasion of large vascular structures.
- Participants with untreated or unstable brain metastases or spinal cord compression.
- Participants with active secondary malignancy interfering with study.
- Participants unable to take oral medication or with severe gastrointestinal disease.
- Participants with metabolic disorders affecting treatment or safety.
- Participants previously treated with Fruquintinib.
- Participants with hypersensitivity to Fruquintinib or its ingredients.
- Participants taking strong CYP3A4 inducers or inhibitors within specified time frames.
- Participants taking other investigational drugs.
- Participants with active oral mucosal inflammation or pathology interfering with device use.
- Participants on calcium channel blockers unless discontinued 7 days prior to device use and abstain during treatment.
- Pregnant or breastfeeding participants.
- Participants who received a live vaccine within 28 days before Fruquintinib.
- Participants unwilling or unable to follow the study protocol or use the device due to cognitive or physical limitations.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive treatment with the TheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device three times daily continuously, combined with daily Fruquintinib administered in cycles of 3 weeks on treatment and 1 week off.
Regular visits according to treatment cycles
Duration - Up to 5 years after treatment discontinuation
Participants are monitored for safety and overall survival for up to 5 years after treatment ends.
Periodic visits over follow-up period
Trial Site Locations
Total: 9 locations
1
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, United States, 48706
Actively Recruiting
2
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, United States, 48346
Actively Recruiting
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
4
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
5
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
6
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States, 48446
Actively Recruiting
7
Karmanos Cancer Institute at McLaren Macomb
Macomb, Michigan, United States, 48043
Actively Recruiting
8
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, United States, 49770
Actively Recruiting
9
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, United States, 48060
Actively Recruiting
Research Team
M
Mohammed Najeeb Al Hallak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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