Can sound waves supercharge immunotherapy against bile duct cancer?
NCT ID NCT07766187
First seen Aug 14, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This trial is testing whether adding a non-invasive ultrasound treatment called histotripsy to the immunotherapy drug durvalumab can strengthen the body's immune response against advanced intrahepatic cholangiocarcinoma, a type of bile duct cancer. Histotripsy uses focused sound waves to destroy tumor tissue, which may release cancer antigens and boost the immune system. The study will enroll 12 people whose cancer is controlled after initial chemotherapy and immunotherapy, and will measure immune changes, safety, and how long the cancer stays controlled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- histotripsy (focused ultrasound) combined with durvalumab (immunotherapy)
- What this could lead to
- If successful, this combination could enhance the immune system's ability to fight bile duct cancer, potentially improving outcomes for patients with this difficult-to-treat disease.
- What could go wrong
- This is a small early-stage trial, so results may not apply broadly. The treatment could cause immune-related side effects or fail to boost the immune response as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) \<2.5x upper limit of normal (ULN) and/or bilirubin \<2.5 ULN. * Renal function: serum creatinine \<2x ULN. * Hematologic function: Absolute neutrophil count \>1,000/uL and platelet \>50,000/uL, hemoglobin \>8.0 g/dL. * Participant has an International Normalized Ratio (INR) score of \<3.0, ≤7 days prior to the planned histotripsy procedure date. * Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to registration. * Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for up to 14 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for up to 11 months after the last dose of study drug(s). * Ability of the participant to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee. Exclusion Criteria: * Participant is pregnant or planning to become pregnant or nursing (lactating) during the trial period. * Participant is enrolled in another investigational trial and/or is taking investigational medication or treated with an investigational device ≤30-days prior to planned histotripsy procedure date. * In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe histotripsy treatment, including but not limited to interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. . * Participant has major surgical procedure or significant traumatic injury ≤2 weeks prior to the planned treatment or not fully recovered (CTCAE grade 1 or better) from side effects/complications of such procedure or trauma. * Participant has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from any adverse effects (exceptions for alopecia, grade 2 neuropathy, grade 2 hypothyroidism, grade 2 hypoadrenalism) related to previous anti-cancer therapy. Please refer to inclusion criteria for lab-based enrollment parameters. * Participant has a history of bleeding disorders (e.g. von Willebrand disease) or subject is suspected to have a bleeding disorder. * Participant has uncorrectable coagulopathy. * In the opinion of the Investigator, histotripsy is not a treatment option for the subject. * Participant has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol. * Participants' tumor(s) is not targetable per discretion of radiologist. * Participant has a known sensitivity to contrast media and cannot be adequately pre-medicated. * Participants' Target Tumor(s) has/have had prior locoregional therapy (e.g. ablation, embolization, radiation). * History of solid organ or allogeneic bone marrow transplantation. * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial. * Significant dementia or other mental condition that precludes the participant's ability to consent to the study. * Untreated central nervous system (CNS) metastasis. Screening of asymptomatic patients for CNS metastasis is not required for enrollment. * Live vaccine administration within 28 days of planned initial dose of durvalumab.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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University of Wisconsin
Madison, Wisconsin, 53706, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can blood tests reveal how liver and bile duct cancers respond to treatment?
- Can a pill target Hard-to-Treat bile duct cancers? a new drug puts FGFR2 mutations to the test
- Can matching drugs to tumor genes beat biliary cancer?
- Can freezing tumors boost immunotherapy in hard-to-treat bile duct cancers?