Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07766187
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Histotripsy — DEVICE
    Histotripsy will be performed using the Edison® System (HistoSonics, Inc.), which is FDA cleared for destruction of liver tissue using non thermal focused ultrasound. Performed on Cycle 1 Day 8 (C1D8) to treat the Target Tumor.
  • Durvalumab — DRUG
    Durvalumab is an immunotherapy drug and will be administered on day 1 of each 28-day cycle as per local standards. Dosing of maintenance durvalumab is 1500mg IV per FDA labeling with administration performed over 60 minutes as per standard clinical practice.
  • Biopsy — PROCEDURE
    Two research biopsies are planned for cycle 1 day 3 and cycle 1 day 22, before and after histotripsy.

Study Details

The purpose of this research is to evaluate whether adding histotripsy to maintenance durvalumab increases immune response and to assess the safety of this combination for participants with advanced intrahepatic cholangiocarcinoma (iCCA). Histotripsy is a non-invasive, non-thermal treatment that uses focused ultrasound energy to destroy tumor tissue. 12 people will be enrolled in this study.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2032
Completion
Aug 31, 2032

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with advanced iCCA
    3 research specific visits; pre-histotripsy treatment (C1D3), 14-day post histotripsy follow-up with biopsy (C1D22), and 30-day post histotripsy treatment adverse events assessment. The remaining visits, including the histotripsy treatment and durvalumab infusions, are a part of the study protocol but are part of the patient's ongoing medical care. Participants followed until progression up to 5 years.

Primary Outcome Measure

Number of Participants with Increase in Adaptive Immune System Response following histotripsy [ Time Frame: data collected cycle 1 day 3 (C1D3) and cycle 1 day 22 (C1D22) (up to about 30 days with allowable procedural windows) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53706-

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By research site
University of Wisconsin· Madison, WI

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