What is this trial studying for metastatic colorectal adenocarcinoma?

This trial is studying whether combining amplitude-modulated radiofrequency electromagnetic fields with Fruquintinib can improve survival and be safe for people with metastatic colorectal cancer that has not responded to other treatments. The research is led by the Barbara Ann Karmanos Cancer Institute. Participants receive both treatments to evaluate their combined effects on disease progression.

Who may be eligible for this metastatic colorectal cancer clinical trial?

Adults aged 22 years or older with confirmed metastatic colorectal adenocarcinoma who have tried standard treatments but their cancer has progressed may be eligible. Both men and women can participate. People must have good organ function, be able to take oral medications, and have a performance status allowing daily activities. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic colorectal cancer clinical trial?

Study-related care, including the study device, drug, and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 22Years +

All Genders

ID07130903

Phase 2 Study of Adding Amplitude-Modulated Radiofrequency Electromagnetic Fields Device to Fruquintinib for Treatment-Resistant Metastatic Colorectal Cancer

Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-11-10

102

Participants Needed

Research Sites

104 weeks

Total Duration

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, MSIMMR, 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

Age: 22Years +

All Genders

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.

Research Team

Mohammed Najeeb Al Hallak, MD

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Phase 2 Study of Adding Amplitude-Modulated Radiofrequency Electromagnetic Fields Device to Fruquintinib for Treatment-Resistant Metastatic Colorectal Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria