RecruitingEarly Phase 1NCT07193862

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis

Sponsor

Northwell Health

Enrollment

10 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a tiny implantable microdevice that can be placed directly into a liver tumor during surgery, where it exposes the tumor to multiple chemotherapy drugs at the same time, to see which drugs work best for that specific patient's cancer. **You may be eligible if...** - You are 18 or older with confirmed colorectal cancer that has spread to the liver - Your liver tumor is at least 2 cm on imaging (CT or MRI) - You are already scheduled for liver surgery (hepatectomy) as part of your standard treatment plan - Your blood counts, clotting, and organ function are within normal ranges **You may NOT be eligible if...** - You are not already scheduled for liver surgery - Your liver tumor is too small (under 2 cm) or in a location that makes the microdevice implantation unsafe - Your blood counts, kidney function, or clotting factors are outside the required normal ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDoxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373

Patients with diagnosed liver metastasis from a colorectal primary deemed resectable. The study intervention will be limited to the percutaneous placement of up to 2 IMDs per lesion with a maximum of 4 devices total, with the subsequent en bloc resection of the tumor plus IMD within 3 (+2) days after placement. The microdevices will remain in the tumor for a minimum of a 2-day incubation period, although ideally for 3 days. The IMD is a small cylindrical device approximately 750 um in diameter and 5 mm in length (Figure 2), housing up to 21 reservoirs. It is made of PEEK, biocompatible material used in other implantable constructs, including joint replacements. 11-13 Drugs are solubilized with poly-ethylene glycol (PEG) and loaded into the individual reservoirs. The drug diffusion has been mapped extensively to ensure that the weight of PEG is selected such that drug diffusion is limited and will not mix or interfere with another drug.