Colorectal Cancer, Liver Cancer, Liver Metastases
Conditions
Keywords
Histotripsy, Liver-confined, Liver colorectal cancer liver metastasis, Liver-confined colorectal cancer liver metastasis, Chemotherapy, Advanced Colorectal, Advanced Colorectal Liver Metastasis
Brief 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.
Detailed description
This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been approved by the FDA with De Novo classification for non-invasive destruction of liver tumors. Up to 100 participants with colorectal cancer liver metastasis will be included.
Interventions
DEVICEHistoSonics Edison® System
Histotripsy 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.
DRUGChemotherapy
Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).
Sponsors
Case Comprehensive Cancer Center
HistoSonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a single arm, prospective, non-randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Participants aged ≥18 years
Exclusion criteria
* 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 * Other non-skin malignancy within 2 years of study * WBC count \< 3,000 /uL * Absolute Neutrophil Count \< 1,500 /uL * History of Non-malignant serious concurrent illness that would increase the risk of histotripsy * Participants with MSI-High * Participants aged \< 18 years * Pregnant participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiologic tumor viability | 90 days post-treatment | As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Tumor Necrosis | 30 days post-treatment | Biopsy results will be used to assess the degree of tumor necrosis in treated lesions. |
| Percentage of Viable Tumor in Lesion | 30 days post-treatment | Biopsy results will be used to assess the percentage of lesions that have viable tumor. |
| Infiltration of CD4 | 30 days post-treatment | Biopsy results will be used to assess the infiltration of CD4. |
| Infiltration of CD8 | Baseline, 30 days post-treatment | Biopsy results will be used to assess the infiltration of CD8. |
| Infiltration of B-cells | 30 days post- treatment | Biopsy results will be used to assess the infiltration of B-cells. |
| Infiltration of CD45 | 30 days post-treatment | Biopsy results will be used to assess the infiltration of CD45. |
| Infiltration of CD68 | 30 days post-treatment | Biopsy results will be used to assess the infiltration of CD68. |
| Infiltration of PD-1 | 30 days post-treatment | Biopsy results will be used to assess the infiltration of PD-1. |
| Infiltration of PD-L1 | 30 days after treatment | Biopsy results will be used to assess the infiltration of PD-L1. |
| Infiltration of CTLA-4 | 30 days post-treatment | Biopsy results will be used to assess the infiltration of CTLA-4. |
| Overall Survival | Up to 24 months post-treatment | Median overall survival will be measured up to 2 years post treatment. |
| Progression Free Survival (PFS) | Up to 24 months post-treatment | The rate of progression free survival will be measured up to 2 years post treatment. |
| 30 day Complications | 30 days post-treatment | The safety profile of the treatment, as measured by the complications at 30 days. |
| 90 day Complications | 90 days post-treatment | The safety profile of the treatment, as measured by the complications at 90 days. |
Countries
United States
Contacts
CONTACTFederico Aucejo, MD
CONTACTErlind Allkushi
PRINCIPAL_INVESTIGATORFederico Aucejo, MD
Cleveland Clinic, Digestive Disease Institute
Outcome results
None listed