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Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma

NCT07766187 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DEVICE

Histotripsy

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.

DRUG

Durvalumab

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.

PROCEDURE

Biopsy

Two research biopsies are planned for cycle 1 day 3 and cycle 1 day 22, before and after histotripsy.

Sponsors & Collaborators

  • HistoSonics, Inc.

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • John Swietlik, MD · UW School of Medicine and Public Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2032-08-31
Completion
2032-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766187 on ClinicalTrials.gov