Metastatic Colorectal AdenocarcinomaPhase 2NCT07130903
Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer
A Phase 2 study testing Fruquintinib and TheraBionic P1 in people with Metastatic Colorectal Adenocarcinoma, run by Barbara Ann Karmanos Cancer Institute at 9 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Metastatic Colorectal Adenocarcinoma
- What is being tested?
- Fruquintinib and TheraBionic P1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Sep 2025to 17 Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Participants who have undergone major surgery within 30 days prior to the first dose of study drug or if they still have unhealed surgical incision from previous surgery.
- Participants with any unresolved toxicities from a previous antitumor treatment greater than NCI CTCAE v5.0 grade 2.
- Participants that have current drug or alcohol abuse.
- Participants with known human immunodeficiency virus (HIV) infection are not eligible if their viral load and/or CD4 (cluster of differentiation 4) count are considered poorly controlled with anti-HIV therapy.
- Participants with a known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants that test positive for hepatitis C virus (HCV) but are currently being treated are eligible if they have an undetectable HCV viral load.
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, 48706
Mohammed N Al Hallak, M.D.
- Recruiting
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
Mohammed N Al Hallak, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Mohammed N Al Hallak, MD, 1-800-527-6266
- Recruiting
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
Mohammed N Al Hallak, MD
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Mohammed N Al Hallak, MD
- Recruiting
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, 48446
Mohammed N Al Hallak, MD
- Recruiting
Karmanos Cancer Institute at McLaren Macomb
Macomb, Michigan, 48043
Mohammed N Al Hallak, MD
- Recruiting
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, 49770
Mohammed N Al Hallak, MD
- Recruiting
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060
Mohammed N Al Hallak, MD
About this study
Official title: A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer
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
- Metastatic Colorectal Adenocarcinoma
- Being tested
- Fruquintinib, TheraBionic P1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called Fruzaqla, HMPL-013
Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class
TheraBionic P1Device
TheraBionic P1 is a amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device
| Study group | Role | What they receive |
|---|---|---|
| Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib | Experimental | TheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device 3 times daily (continuous) plus Fruquintinib daily (3 weeks on and 1 week off) Receives: Drug: Fruquintinib; Device: TheraBionic P1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival (OS) is defined as the time duration from treatment start until death of any cause. The distribution of OS will be graphically summarized by a Kaplan-Meier (KM) curve, and median OS (mOS) and its one-sided 85% (i.e., two-sided 70%) confidence interval (CI) will be estimated using KM estimates.
Measured: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Secondary outcomes (5)
Safety and Tolerability
Analyses will be performed for all participants who have received fruquintinib and TheraBionic P1 treatment. AEs will be graded based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Adverse Events will be summarized by count and frequency. Corresponding two-sided 95% CI will be calculated using Clopper and Pearson's method.
Measured: From start of treatment to 28 days post device discontinuation
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time duration from treatment start to progression or death of any cause. Progression of disease will be assessed and determined by the treating investigator. A one-sample log-rank test will be performed to evaluate PFS. The distribution of PFS will be graphically summarized by Kaplan-Meier (KM) curve and median PFS (mPFS) and its 95% CI will be estimated using KM estimates.
Measured: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Rates of progressive disease
The proportions of participants whose disease has progressed after treatment initiation will be computed by dividing the number of participants with progression by the total number of patients who were followed.
Measured: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Changes in serum Carcinoembryonic Antigen (CEA)
Serum CEA will be measured at baseline, on Day 1 of each cycle, and at the end of treatment. Distribution of levels of serum CEA will be checked and, if needed, data transformation will be employed for normality. The levels of serum CEA will be descriptively summarized using mean, median, standard deviation (SD), range, and 95% CI per each time point. The changes in serum CEA will be also descriptively summarized using the same descriptive statistics. The associations between the change of serum CEA and each of efficacy outcomes will be descriptively evaluated using logistic and Cox proportional hazard regression models. The proportional hazard assumption will be checked and, if violated, a weighed Cox regression model or restricted mean survival time will be utilized.
Measured: Through study completion, up to 1 year
Changes in serum microRNA (miRNA)
Serum miRNA levels will be assessed at baseline, on Day 1 of the first two cycles, and a final sample will be collected at progression or end of treatment (whichever comes first). The distribution of levels of serum microRNA will be checked and, if needed, data transformation will be employed for normality. The levels of serum miRNA will be descriptively summarized using differential expression (DE) fold change > 2 p0.05 and 95% CI for each timepoint. The changes in serum miRNA will be also descriptively summarized using the same descriptive statistics. The associations between the change of serum miRNA and each of the efficacy outcomes (OS and PFS) will be descriptively evaluated using logistic and Cox proportional hazard regression models. The proportional hazard assumption will be checked and, if violated, a weighed Cox regression model or restricted mean survival time will be utilized.
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start10 Sep 2025
- Primary completion17 Apr 2028 (estimated)
- Study completion17 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- THERABIONIC INC.
- Responsible party
- Principal investigator, Mohammed Najeeb Al Hallak, Barbara Ann Karmanos Cancer Institute
- Investigators
- Mohammed Najeeb Al Hallak, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130903
- Sponsor's protocol ID
- 2025-035
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07130903
- Acronym / sponsor ID
- 2025-035
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- THERABIONIC INC.
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 17 Apr 2030 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib | Experimental | Drug: Fruquintinib, Device: TheraBionic P1TheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device 3 times daily (continuous) plus Fruquintinib daily (3 weeks on and 1 week off) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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):
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FruquintinibAlso: Fruzaqla, HMPL-013Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class | Drug | Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib |
| TheraBionic P1TheraBionic P1 is a amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device | Device | Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib |
Primary outcome
Overall Survival (OS)
Time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Overall survival (OS) is defined as the time duration from treatment start until death of any cause. The distribution of OS will be graphically summarized by a Kaplan-Meier (KM) curve, and median OS (mOS) and its one-sided 85% (i.e., two-sided 70%) confidence interval (CI) will be estimated using KM estimates.
5 secondary outcomes
Safety and Tolerability
Time frame: From start of treatment to 28 days post device discontinuation
Progression-free survival (PFS)
Time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Rates of progressive disease
Time frame: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Changes in serum Carcinoembryonic Antigen (CEA)
Time frame: Through study completion, up to 1 year
Changes in serum microRNA (miRNA)
Time frame: Through study completion, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Najeeb Al Hallak, MD principal investigator
Wayne State University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib and TheraBionic P1 in people with Metastatic Colorectal Adenocarcinoma, run by Barbara Ann Karmanos Cancer Institute at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Najeeb Al Hallak, MD (13135768718, alhallakm@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.