Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma (CODAH Trial)
University of Wisconsin, Madison
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.
Description
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 (ct…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant diagnosed with histologically confirmed intrahepatic cholangiocarcinoma * Participant demonstrates disease control following 18 weeks of chemotherapy (gemcitabine and/or cisplatin) and immunotherapy (durvalumab) as part of standard of care first line regimen. * Participants are allowed to be on maintenance durvalumab therapy following disease control at 18 weeks prior to enrollment into the study. * All participants must have prior biopsy confirming diagnosis of cholangiocarcinoma. * Participant has iCCA tumor burden appropriate for biopsy and histo…
Interventions
- DeviceHistotripsy
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.
- DrugDurvalumab
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.
- ProcedureBiopsy
Two research biopsies are planned for cycle 1 day 3 and cycle 1 day 22, before and after histotripsy.
Location
- University of WisconsinMadison, Wisconsin