A Pilot Study Assessing the Safety and Efficacy of Histotripsy as an Adjunctive Treatment for Biliary Tract Cancer
NYU Langone Health
Summary
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.
Description
For cohort 1, histotripsy will be added to chemoimmunotherapy regime with gemcitabine + cisplatin + durvalumab/pembrolizumab (GCD/P) in patients with untreated locally advanced/metastatic BTCs. Peripheral blood sampling and imaging assessment will be done for all patients at baseline and after every 4 treatment cycles. For cohort 2, histotripsy will be added in the setting of biliary tract obstruction in patients with untreated locally advanced/metastatic BTC and concomitant biliary tract obstruction unrelieved by biliary stenting. Patients who become eligible for chemoimmunotherapy will unde…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Both Cohorts 1. Age \>/= 18 at time of screening 2. Willing and able to provide informed consent for the trial 3. Histologically or cytologically confirmed biliary tract cancer (BTC) including cancers of the intrahepatic bile ducts, extrahepatic bile ducts, and gallbladder 4. Locally advanced or metastatic disease not eligible for resection or transplant 5. RECIST v 1.1 measurable disease 6. No prior systemic therapy for the treatment of locally advanced/metastatic disease a. Recurrent disease after surgical resection must have occurred \>/= 6 months from completion of ad…
Interventions
- DrugGemcitabine
1000 mg/m2 over 30 minutes on Days 1, 8, of each cycle (every 3 weeks), infused according to local labeling.
- DrugCisplatin
The reconstituted solution should be administered by IV infusion over a 6- to 8-hour period. Cisplatin is given on Days 1 and 8 of each cycle (every 3 weeks), infused according to local labeling
- DrugDurvalumab
Given on day 1 of each cycle (every 3 weeks), infused according to local labeling. Administer infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
- DrugPembrolizumab
Given on day 1 of each cycle (every 3 weeks), infused according to local labeling. Administer diluted solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
- DeviceHistotripsy
Histotripsy is a non-invasive medical technique that uses focused ultrasound waves to mechanically break down and destroy targeted tissues through a process called cavitation.
Location
- NYU Langone HealthNew York, New York