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Chemotherapy

Chemoimmunotherapy + Hyperthermia + Radiotherapy for Biliary Tract Cancer

Phase 1

Waitlist Available

Led By Jason Molitoris, MD, PhD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.5 x 109/L, Platelet count ≥ 100 x 109/L, Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), Alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN, Measured creatinine clearance > 50 mL/min or calculated creatinine clearance > 50 mL/min as determined by Cockcroft-Gault (using actual body weight)

No prior exposure to gemcitabine or platinum-based chemotherapy

Must not have

Major surgical procedure within 28 days prior to enrollment

Prior locoregional therapy with radioembolization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post completion of accrual

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the outcome of patients with biliary tract cancer ineligible for surgery. Participants will receive a combination of standard chemoimmunotherapy along with radiation and deep hyperthermia. The

Who is the study for?

This trial is for patients with advanced biliary tract cancer who are not candidates for surgery. Participants will receive a combination of standard chemoimmunotherapy (gemcitabine, cisplatin, durvalumab), radiation therapy, and deep hyperthermia to test if this improves outcomes.

What is being tested?

The study tests the effectiveness of adding spatially fractionated radiation therapy and deep hyperthermia to standard chemoimmunotherapy in treating biliary tract cancer. The treatment includes four cycles of chemotherapy combined with immunotherapy drugs and targeted radiation.

What are the potential side effects?

Potential side effects may include typical reactions from chemotherapy like nausea, fatigue, hair loss; immunotherapy-related issues such as immune system overactivity; skin irritation or burns from radiation; and discomfort or burns from hyperthermia treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with gemcitabine or platinum-based chemotherapy.

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I have never been treated with anti-PD1 or anti-PDL1 antibodies.

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I am 21 years old or older.

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My cancer is in the bile ducts or gallbladder and cannot be removed by surgery.

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I can take care of myself and am up and about more than half of the day.

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I have a tumor in my abdomen or pelvis that can be targeted with radiation.

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My body weight is over 30 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 28 days.

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I have had radioembolization for cancer treatment.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have brain metastases or spinal cord compression that hasn't been treated.

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I have not received a live vaccine in the last 30 days.

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My lung function is severely reduced, below half of what's expected.

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My pelvic/abdominal width is over 49 cm.

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I have been diagnosed with ampullary carcinoma.

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I have had radiation therapy at the site where I am now seeking treatment.

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I have a history of lung inflammation not caused by an infection.

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I do not have any serious ongoing illnesses that would affect my participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post completion of accrual

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post completion of accrual

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post completion of accrual for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of adverse events assessment by CTCAE v5.0 that are grade 3 or higher and related to HT or SFRT

Number of participants to receive a minimum of 30 minutes of heating at target temperature (39-43°C) for at least 2 of the planned 3 deep HT treatments

Secondary study objectives

Radiographic Response Rate

Other study objectives

Measure absolute number of immune cell subsets

Measure activation status of immune cell subsets

Measure distribution of immune cell subsets

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemoimmunotherapy + SFRT + Deep HyperthermiaExperimental Treatment5 Interventions

1. Gemcitabine 1000mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles 2. Cisplatin 25mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles 3. Durvalumab 1500mg via intravenous infusion on day 1 of every 21-day cycle for up to 8 cycles 4. Deep hyperthermia and spatially-fractionated radiotherapy will be administered to 1 measurable lesion on cycle 2-day 1 and deep hyperthermia alone will be delivered to the same lesion on cycle 3-day 1 and cycle 4-day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Cisplatin

2013

Completed Phase 3

~3120