Recruiting nowEarly phase 1
What this trial is trying to do
The researchers are testing whether a tiny implantable device can release small amounts of chemotherapy and immune-modulating drugs directly into a colorectal cancer liver metastasis, so the surrounding tissue can show which drugs affect it. The device is placed through the skin a few days before planned surgery and removed with the tumour for laboratory analysis.
The idea is that measuring drug effects inside the patient’s tumour could eventually help select treatment more precisely than relying only on laboratory tests or giving several drugs systemically. In this trial, however, the practical aim is to see whether the device can be placed and removed safely and whether drug diffusion and tissue effects can be measured—not whether it extends survival or delays cancer growth.
Worth knowing: This is a small, non-randomised early-phase safety study with no comparison group; its main outcome is complications from device placement and retrieval, not treatment benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07193862 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Early phase 1 |
| Design | open label |
| Taking part | 10 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Northwell Health |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Combination product Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373
What it is measuring
Incidence of adverse events (AEs) associated with Microdevice placement and retrieval
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Early phase 1. The earliest human testing. The question is how the drug behaves in the body, not yet whether it helps.
How the researchers describe it
Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +/- immune-modulating drugs has an impact on the surrounding tissue.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 2 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07193862, registered by Northwell Health on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.