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Recruiting NCT07044362

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

No phase Interventional Colorectal Cancer Liver Metastases Liver Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HistoSonics Edison® System, Chemotherapy.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Liver Metastases, Liver Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial

Overview

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

  • Device HistoSonics 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.
  • Drug Chemotherapy
    Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).

Primary outcome measures

  • Radiologic tumor viability [Time frame: 90 days post-treatment]
Secondary outcome measures (12)
  • Rate of Tumor Necrosis [Time frame: 30 days post-treatment]
  • Percentage of Viable Tumor in Lesion [Time frame: 30 days post-treatment]
  • Infiltration of CD4 [Time frame: 30 days post-treatment]
  • Infiltration of CD8 [Time frame: Baseline, 30 days post-treatment]
  • Infiltration of B-cells [Time frame: 30 days post- treatment]
  • Infiltration of CD45 [Time frame: 30 days post-treatment]
  • Infiltration of CD68 [Time frame: 30 days post-treatment]
  • Infiltration of PD-1 [Time frame: 30 days post-treatment]
  • Infiltration of PD-L1 [Time frame: 30 days after treatment]
  • Infiltration of CTLA-4 [Time frame: 30 days post-treatment]
  • Overall Survival [Time frame: Up to 24 months post-treatment]
  • Progression Free Survival (PFS) [Time frame: Up to 24 months post-treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland

Identifiers

NCT: NCT07044362 · CASE6224

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗