Actively Recruiting

Phase 2
Age: 22Years +
All Genders
NCT07130903

Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination 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

240 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

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

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed metastatic colorectal adenocarcinoma with documented RAS, BRAF, MSI/MMR, and HER2 status
  • Progressed on or intolerant to fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy
  • Progressed on or intolerant to anti-VEGF biological therapy (e.g., bevacizumab, aflibercept, ramucirumab)
  • If RAS wild type, progressed on or intolerant to anti-EGFR therapy (e.g., cetuximab, panitumumab)
  • Have evaluable disease by CT, MRI, or PET scan
  • Body weight at least 40 kg
  • Age 22 years or older
  • Able to understand and willing to sign informed consent
  • ECOG performance status 0-2
  • Adequate organ and marrow function within 14 days before treatment
  • Expected lifespan greater than 12 weeks
  • Women of child-bearing potential must agree to avoid pregnancy; males must avoid impregnating partners during treatment and for 14 days after last dose
Not Eligible

You will not qualify if you...

  • Uncontrolled hypertension
  • History or presence of gastric/duodenal ulcer, ulcerative colitis, unresected gastrointestinal tumor hemorrhage, perforation, or fistulas
  • Hemorrhage from any site within 2 months before screening
  • Thromboembolic events within 3 months before screening unless stable on anticoagulants; exclusion if recent massive pulmonary embolism
  • Stroke or transient ischemic attack within 12 months before screening
  • Significant cardiovascular disease including recent heart attack, unstable angina, severe heart failure, ventricular arrhythmias, or low left ventricular ejection fraction
  • Prolonged QT interval or risk factors for arrhythmic events
  • Taking medications that prolong QT interval
  • Systemic anti-neoplastic therapies within 4 weeks before first dose
  • Targeted therapies within 5 half-lives or 4 weeks before first dose
  • Major surgery within 30 days before first dose or unhealed surgical incision
  • Unresolved toxicities from prior treatment above grade 2
  • Current drug or alcohol abuse
  • Poorly controlled HIV infection
  • Active viral hepatitis unless well controlled
  • Active infections requiring intravenous antibiotics
  • Tumor invasion of large vascular structures
  • Untreated or unstable brain metastases or spinal cord compression
  • Active secondary malignancy interfering with study
  • Unable to take oral medication or use device
  • Metabolic disorders affecting study drug action
  • Prior fruquintinib treatment
  • Hypersensitivity to fruquintinib or ingredients
  • Taking strong CYP3A4 inducers or inhibitors
  • Taking calcium channel blockers or similar agents unless discontinued 7 days before device treatment
  • Pregnant or breastfeeding
  • Live vaccine within 28 days before first dose
  • Unable or unwilling to follow study protocol or use device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

M

Mohammed Najeeb Al Hallak, MD

CONTACT

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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