Electric field device takes on liver tumors in early trial
NCT ID NCT03203525
First seen Jun 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times
Summary
This early-phase study tests a portable device that sends gentle electric fields to the liver, combined with chemotherapy and a targeted drug (bevacizumab), in people whose cancer has spread to the liver and stopped responding to standard treatments. The main goal is to find the safest dose and see if the combination can shrink tumors. About 38 participants will be enrolled at MD Anderson Cancer Center.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bevacizumab (Avastin) plus chemotherapy drugs (oxaliplatin, leucovorin, fluorouracil, pegylated liposomal doxorubicin hydrochloride, temsirolimus) and the NovoTTF-100L(P) device that delivers electric fields
- What this could lead to
- If it works, this could point toward a new way to treat liver metastases by combining electric fields with standard drugs to better control tumor growth.
- What could go wrong
- This is a very early phase I trial with only 38 people, so it is mainly checking safety and side effects. It may not show clear benefit, and the device plus drugs could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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38 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with advanced malignancies, either refractory to standard therapy or for which no effective standard therapy is available, unless the drugs in the protocol are part of the standard of care for a specific diagnosis * Predominant hepatic metastasis is defined as at least 50% of the total tumor burden involving the liver * An aberrant PI3K pathway such as PIK3CA mutations or PTEN loss, is detected in a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory * For patients who are enrolled into the arm of FOLFOX6 plus bevacizumab, they must have metastatic colorectal cancer with predominant hepatic metastases * For patients who are enrolled into the arm of DAT, they must have predominant hepatic metastases harboring an aberrant PI3K pathway * Patients must have measurable or evaluable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., hormonal, barrier device, or abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose of the study agents * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Neutrophils \>= 1,500/uL * Platelets \>= 100,000/uL * Total bilirubin =\< 1.5 x ULN (upper limit of normal) (except patients with Gilbert's syndrome, who must have a total bilirubin =\< 3.0 mg/dL) * Alanine aminotransferase (ALT) =\< 3 x ULN or =\< 5 x ULN if liver metastases persist * Serum creatinine =\< 1.5 mg/dL or calculated creatinine clearance \>= 50 mL/minutes * Patients should be able to read and fully understand the requirements of the trial, be willing to comply with all trial visits and assessments, and be willing and able to sign an Institutional Reviewed Board (IRB)-approved written informed consent document * Patients may receive palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, uncontrolled systemic hypertension (systolic blood pressure \[BP\] \> 140 mm Hg, diastolic BP \> 90 mm Hg), left ventricular ejection fraction \< 50%, active bleeding, or psychiatric illness/social situations that would limit compliance with study requirements * Patients who have not recovered from major surgical procedure, or significant traumatic injury (i.e., patients still need additional medical care for these issues) * History of allergic reactions to the study drugs or their analogs, or any component of the products, or sensitive to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes * Any treatment specific for tumor control within 3 weeks of drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting fewer than 4 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and similar agents), or failure to recover from the toxic effect of any of these therapies prior to study entry * Symptomatic primary tumors or metastasis of brain and/or central nervous system that are uncontrolled with antiepileptics and requiring high doses of steroids * Implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices * Corrected QT interval (QTc) is greater than 480 milliseconds (msec) at screening, or documented clinically significant arrhythmias. The QTc formula Bazett will be used for assessing subject eligibility * History of stroke or transient ischemic attack, peripheral vascular disease, active gastric or duodenal ulcer, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment * Patients with known human immunodeficiency virus infection, active hepatitis B or C * Women who are pregnant will be excluded from the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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