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Histotripsy in Biliary Tract Cancer

ConditionBiliary Track Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >/= 18 at time of screening

Willing and able to provide informed consent for the trial

Histologically or cytologically confirmed biliary tract cancer (BTC) including cancers of the intrahepatic bile ducts, extrahepatic bile ducts, and gallbladder

Locally advanced or metastatic disease not eligible for resection or transplant

Disqualifiers

Prior exposure to immune-mediated therapy, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies

History of allogeneic or solid organ transplant

Patients with vitiligo or alopecia.

Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Patients eligible for chemoimmunotherapyExperimental treatment 5 interventions
Group B: Cohort 2: Patients not eligible for chemoimmunotherapyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) defined as the proportion of patients with a best overall response of either Complete Response (CR) or Partial Response (PR), as determined by standardized imaging criteria (RECIST v1.1)

Time frame
up to 24 months
2

Incidence of serious adverse events (SAEs)

Incidence of serious adverse events (SAEs) defined as events that are life-threatening, require hospitalization, result in disability, etc.

Time frame
up to 24 months
3

Incidence of major procedure-related complications through 30 days post-histotripsy

Incidence of major procedure-related complications through 30 days post-histotripsy defined as an AE classified as CTCAE grade 3 or higher

Time frame
through 30 days post-histotripsy

Secondary outcomes

1

Duration of response (DOR)

Duration of response (DOR) defined as the time from the first documentation of a Complete Response (CR) or Partial Response (PR) until the date of disease progression or death from any cause

Time frame
up to 24 months
2

Disease control rate (DCR)

Disease control rate (DCR) defined as the proportion of patients who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD)

Time frame
up to 24 months
3

Progression free survival (PFS)

Progression free survival (PFS) defined as the time from the date of first treatment to the earliest date of documented disease progression (as determined by imaging per RECIST v1.1) or death from any cause

Time frame
up to 24 months
4

Overall survival (OS)

Overall survival (OS) defined as the time from the date of first treatment to the date of death from any cause

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: