Title
Combination therapy using durvalumab and histotripsy for treatment of intrahepatic cholangiocarcinoma (CODAH trial)

Description
Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma (CODAH Trial)

Objective
The primary objective of this pilot phase II study is to evaluate preliminary efficacy of increased immune system activation and safety of combined histotripsy and maintenance durvalumab therapy.

The secondary objectives are to evaluate additional efficacy signal and safety of the addition of histotripsy along with continued maintenance durvalumab therapy.

Exploratory objectives include evaluation for off-target effects on iCCA tumors not targeted for histotripsy treatment and evaluation of peripheral blood samples for assessment of circulating immune biomarkers and circulating tumor DNA (ctDNA).

Treatment 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 Eligibility For full study eligibility see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Liver

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital