Histotripsy in Biliary Tract Cancer

Conditions

• Biliary Track Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gemcitabine — DRUG
  1000 mg/m2 over 30 minutes on Days 1, 8, of each cycle (every 3 weeks), infused according to local labeling.
• Cisplatin — DRUG
  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
• Durvalumab — DRUG
  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.
• Pembrolizumab — DRUG
  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.
• Histotripsy — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Oct 2, 2026

Start date

Sep 30, 2026

Status verified

Sep 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

24 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Patients eligible for chemoimmunotherapy
  Eligible patients will undergo histotripsy and therapy with GCD/P (gemcitabine 1,000 mg/m2 IV and cisplatin 25 mg/m2 IV days 1 and 8 with durvalumab 1,500 mg IV or pembrolizumab 200 mg IV day 1 in 21-day cycles) until disease progression or intolerable toxicity. Patients will have the option of narrowing to maintenance durvalumab/pembrolizumab with or without gemcitabine after 4-6 months of GCD/P as per standard-of-care.
• Experimental: Cohort 2: Patients not eligible for chemoimmunotherapy
  Eligible patients will undergo histotripsy (with or without standard of care biliary tract stenting) and then be monitored with weekly hepatic function panels and clinic visits to monitor status of biliary tract obstruction and for candidacy for chemoimmunotherapy. Patients who become eligible for chemoimmunotherapy will undergo treatment with GCD/P as per Cohort 1 until disease progression or intolerable toxicity following the same peripheral blood and imaging schedule as Cohort 1.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to 24 months ]

Central Contacts

• Kristen Spencer, DO, MPHDO, MPH
  212-731-6667
  [email protected]
• Sandra John-Henry
  212-404-4219
  [email protected]

Locations (1)

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