NCT07044362
Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
At risk: Primary completion moved 2 months later.
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Record History
All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗
- Notable Final enrollment: 2 participants, 2% of the 100 planned
- Enrollment closed, study ongoing
- Site details revised
- Notable Start date: Jun 30, 2025 to Nov 19, 2025
- Eligibility criteria expanded, about 16 words
- Primary completion pushed from Oct 1, 2026 to Dec 1, 2026
- Study completion pushed from Oct 1, 2028 to Dec 1, 2028
- Notable Primary completion date: Apr 1, 2026 to Oct 1, 2026
- Study completion date: Apr 1, 2028 to Oct 1, 2028
- Notable Eligibility criteria expanded, about 8 wordsv4
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Jul 2025 to Jun 30, 2025
- Site details revised
- Minor Start date: Jun 2025 to Jul 2025v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Radiologic tumor viability
Timeframe: 90 days post-treatment
Secondary (14)
Rate of Tumor Necrosis
Percentage of Viable Tumor in Lesion
Infiltration of CD4
Infiltration of CD8
Infiltration of B-cells
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Infiltration of CD45
Infiltration of CD68
Infiltration of PD-1
Infiltration of PD-L1
Infiltration of CTLA-4
Overall Survival
Progression Free Survival (PFS)
30 day Complications
90 day Complications
Arms and interventions
Histotripsy + ChemotherapyExperimental
All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.
Devices: HistoSonics Edison® System
Drugs: Chemotherapy
Sites
1 site in 1 country
- Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, Ohio, United States