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Chemotherapy

Chemoimmunotherapy + SFRT + Deep Hyperthermia 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
1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
2. Provision of a signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post completion of accrual
Awards & highlights

Summary

This study is being done to see if the investigators can improve the outcome of patients with biliary tract cancer that do not qualify for surgery. This study will compare the effects, good and/or bad, of using a combination of standard of care chemoimmunotherapy, with the addition of radiation and deep hyperthermia. In this study, participants will be receiving standard of care chemoimmunotherapy (gemcitabine, cisplatin, and durvalumab), radiation (spatially fractionated radiation therapy), and deep hyperthermia. Chemoimmunotherapy Chemoimmunotherapy is when chemotherapy drugs are combined with immunotherapy drugs. Chemotherapy uses different drugs to kill or slow the growth of cancer cells, whereas immunotherapy drugs are used to help the immune system attack cancer cells. For this study, the drugs Gemcitabine, Cisplatin, and Durvalumab will be used. Chemoimmunotherapy will be delivered over 4 cycles for this study and can continue longer if the treating physician decides this is appropriate. Each cycle will last 3 weeks. Spatially fractionated radiation therapy (SFRT) SFRT is a form of radiation therapy that gives a single large dose of radiation to large tumors or tumors that do not qualify for surgery. This is not a standard type of treatment for people with this diagnosis. For this study, participants will be receiving radiation once on day 1 of the second chemoimmunotherapy cycle. Deep Hyperthermia (HT) Hyperthermia is used in combination with chemoimmunotherapy and radiation treatment in this study. Hyperthermia has the potential to make both chemotherapy and radiation treatments more effective. For this study, participants will receive HT three times: on the first day of cycles 2, 3, and 4 of chemoimmunotherapy.

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

Timeline

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

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
Durvalumab
2017
Completed Phase 2
~3840
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
700 Previous Clinical Trials
377,856 Total Patients Enrolled
Jason Molitoris, MD, PhDPrincipal InvestigatorUniversity of Maryland Medical Center / Maryland Proton Treatment Center
~10 spots leftby Dec 2027