No phaseNot yet recruiting
Histotripsy in Biliary Tract Cancer
A Pilot Study Assessing the Safety and Efficacy of Histotripsy as an Adjunctive Treatment for Biliary Tract Cancer
- Sponsor
- NYU Langone Health (Academic or other)
- Enrolment
- 24 planned
- Conditions
- Biliary Track Cancer
- Interventions
- Gemcitabine; Cisplatin; Durvalumab; Pembrolizumab; Histotripsy
- Ages
- adults, older adults
- Registry
- NCT07853690
From the registry
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.
Primary outcomes
- Objective response rate (ORR)
- Incidence of serious adverse events (SAEs)
- Incidence of major procedure-related complications through 30 days post-histotripsy