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

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

Trial Details

NCT ID
NCT07193862
Phase
EARLY_PHASE1
Sponsor
Northwell Health
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373
Locations (sample)
  • Lake Success, New York, United States|40.77066,-73.71763
  • New Hyde Park, New York, United States|40.7351,-73.68791

Key Eligibility Criteria

  • Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed tom…
  • Normal organ and marrow function, defined as follows:
  • Leukocytes ≥3,000/mcL
  • Absolute neutrophil count ≥1500/mcL

For full eligibility, visit ClinicalTrials.gov.

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