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New treatment option for Colorectal Cancer Metastatic
Official title Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
ClinicalTrials.gov ID: NCT07193862
What this study is testing
What is Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373?
Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 is an investigational medicine, being studied as a potential treatment for colorectal cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed...
- Leukocytes ≥3,000/mcL
- Absolute neutrophil count ≥1500/mcL
- Platelets ≥ 100,000/mcL
- PT≤ 14, PTT≤ 38, INR ≤ 1.
You likely can't join if
- Tumor location not amenable to device placement Pregnancy at the time of enrollment or operation due to the known teratogenicity of the medications...
- Prior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint...
See the full eligibility 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...
- 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...
- 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 how well it works assessment of the CLM Extra-hepatic disease or...
The study team makes the final eligibility decision.
Where it's taking place
- Lake Success, New York, United States
- New Hyde Park, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lake Success, New York, United States; New Hyde Park, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.