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NCT07766187
Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma
Conditions: Intrahepatic Cholangiocarcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 12
Sponsor: University of Wisconsin, Madison
Location: University of Wisconsin Madison Wisconsin
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.
Eligibility Criteria
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 histotripsy treatment
* Participant able to undergo liver biopsy of Index Tumor.
* Index Tumor will be a predetermined non-histotripsy tumor in patients with multifocal disease, or a predetermined region of intentionally untreated tumor in patients with solitary disease.
* Participant to have iCCA deemed targetable for histotripsy.
* Participants with solitary tumor must have longest dimension ≥ 2.0 cm to allow for planned region of intentionally untreated Target Tumor for Index Tumor.
* Participants' iCCA is considered unresectable or patient is a non-surgical candidate
* Participant can undergo general anesthesia.
* Participant has a Child-Pugh Score of A or B (up to B8).
* Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.
* Participant meets the following functional criteria, ≤7 days prior to the planned histotripsy procedure date
* Liver function: Alanine transaminase (ALT) and Aspartate transaminase (AST) \8.0 g/dL.
* Participant has an International Normalized Ratio (INR) score of \
Source: ClinicalTrials.gov (NCT07766187). StuddyBuddy aggregates publicly available trial information.