Clinical trialNCT07853690RecruitingInterventional

Histotripsy in Biliary Tract Cancer

SponsorNYU Langone HealthEnrollment24Biliary Track Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this pilot study is to examine the safety and feasibility of histotripsy in two cohorts of 12 patients each with Biliary Track Cancer (BTC), with a plan to expand to a larger multi-center study if both safety and feasibility are demonstrated. All patients from cohort 1 will be evaluated for objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS) of histotripsy in combination with chemoimmunotherapy. Toxicity profile of histotripsy will be characterized for this cohort. For Cohort 2, in addition to the above evaluations, changes in serum bilirubin levels (total and direct) over time, time to biliary decompression or normalization of bilirubin (total and direct), and percent of patients rendered eligible for chemoimmunotherapy with GCD/P will also be assessed.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Kristen Spencer, DO, MPH
NYU Langone Health
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Nyu Langone Health
New York, New York, United States
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cisplatin →Durvalumab →Gemcitabine →Pembrolizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Oct 2026
Primary completion: 30 Sept 2027
Completion: 30 Sept 2028
Last update posted: 20 Oct 2026
Registered enrollment: 24
Registry id: NCT07853690

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.