drugset / Trial / NCT07044362

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

NCT07044362

NaSingle-groupOpen-labelSupportive care

Summary

The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is: • Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival? Participants will: * Receive chemotherapy treatment per standard procedure. * Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic. * Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit. * Participate in genetic testing, as a part of the standard of care for the treatment.

Timeline

Start
2025-06-30
Primary completion
2026-10-01
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Background Irinotecan Small molecule
Background Oxaliplatin Small molecule
Background fluorouracil Small molecule