Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM
Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within 3 months of beginning chemotherapy, or participants who have completed chemotherapy treatment within 1 month of the histotripsy evaluation
Participants who have undergone other liver-directed therapy, such as ablation, embolization
Participants with multiple unresectable metastases that cannot be completely treated with resection and/or ablation
Disqualifiers
Participants with resectable disease
Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.
Participants who are not able to tolerate general anesthesia
Participants who have Childs C Cirrhosis
Trial design
Design model
Single group
Treatments tested in this trial
HistoSonics Edison® System
DeviceHistotripsy is a novel, totally non-invasive, non-ionizing, and non-thermal ablation technique that mechanically disrupts tumors through precisely controlled acoustic cavitation. Histotripsy is administered via HistoSonics Edison® System.
Chemotherapy
DrugChemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Histotripsy + ChemotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Radiologic tumor viability
As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)
Time frame
90 days post-treatmentSecondary outcomes
1
Rate of Tumor Necrosis
Biopsy results will be used to assess the degree of tumor necrosis in treated lesions.
Time frame
30 days post-treatment2
Percentage of Viable Tumor in Lesion
Biopsy results will be used to assess the percentage of lesions that have viable tumor.
Time frame
30 days post-treatment3
Infiltration of CD4
Biopsy results will be used to assess the infiltration of CD4.
Time frame
30 days post-treatment4
Infiltration of CD8
Biopsy results will be used to assess the infiltration of CD8.
Time frame
Baseline, 30 days post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
HistoSonics, Inc.
Collaborator
Source ClinicalTrials.gov