Microchip implanted in liver tumors could personalize cancer treatment
NCT ID NCT07193862
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a small implantable device placed directly into liver tumors from colorectal cancer. The device releases tiny amounts of several chemotherapy and immunotherapy drugs to see how the tumor responds. After a few days, the device is removed along with the tumor during planned surgery. The goal is to check if the procedure is safe and can help guide future treatment choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- implantable microdevice containing chemotherapy and immunotherapy drugs (doxorubicin, FOLFOX, botensilimab, balstilimab, bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373)
- What this could lead to
- If successful, this approach could help doctors choose the most effective drugs for each patient's liver tumors before surgery.
- What could go wrong
- This is a very early safety study with only 10 participants, so it cannot yet prove the device improves treatment outcomes. The device itself could cause complications or fail to provide useful information.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- 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: * Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed tomography (CT) or magnetic resonance imaging (MRI) Planned hepatectomy as part of standardized treatment plan, irrespective of study enrollment ≥18 years of age Normal organ and marrow function, defined as follows: * Leukocytes ≥3,000/mcL * Absolute neutrophil count ≥1500/mcL * Platelets ≥ 100,000/mcL * PT≤ 14, PTT≤ 38, INR ≤ 1. * Creatinine within normal institutional limits OR clearance ≥60mL/min/1.73m2 Feasibility of microdevice implantation based on clinical history as well as extent and anatomical location of the CLM tumor as evaluated by the operating surgical oncologist and interventional radiologist on baseline imaging The effects of the microdevice on a developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours of their operation Ability to understand and willingness to sign informed consent for both the surgical resection and the proposed research study prior to any procedures Males and females of childbearing potential must agree to use effective contraception starting before the first day of treatment and continuing for at least 3 months (men) or 6 months (women) after implantation of the microdevice. Additionally, due to the unknown but potential risks of nursing infants secondary to the treatment of the mother with the chemotherapeutic agents of the study, mothers must agree to discontinue breastfeeding for a total of 14 days after the insertion of the microdevice. Exclusion Criteria: Tumor location not amenable to device placement Pregnancy at the time of enrollment or operation due to the known teratogenicity of the medications involved. Prior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the CLM Extra-hepatic disease or unresectable liver metastasis on baseline imaging
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Long Island Jewish Medical Center
RECRUITINGNew Hyde Park, New York, 11040, United States
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RJ Zuckerberg
RECRUITINGLake Success, New York, 11042, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a vaccine boost immunotherapy against a stubborn cancer?
- What does recovery really look like after aggressive peritoneal cancer surgery?
- Chemo holidays put to the test: can scheduled breaks beat continuous treatment for advanced colorectal cancer?
- Can two immune boosters outsmart Chemo-Resistant colon cancer?
- Could a liver transplant from a living donor help fight colorectal cancer that spread?