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Chemoimmunotherapy, Radiation, and Hyperthermia for Advanced Biliary Tract Cancer

This study is testing a new combination treatment for advanced biliary tract cancer that cannot be removed by surgery. It combines standard chemotherapy drugs (gemcitabine and cisplatin) and an immunotherapy drug (durvalumab) with radiation therapy (Spatially Fractionated RT) and deep hyperthermia (heating a specific area). The goal is to see if this combination improves outcomes. Researchers will be looking for serious side effects (adverse events) and how well the deep hyperthermia treatment is delivered. You may be eligible if you are at least 21 years old and can provide informed consent. The study plans to enroll 15 participants.

Study design
This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive gemcitabine, cisplatin, and durvalumab intravenously for up to 8 cycles (21 days each). You would also receive Spatially Fractionated RT once and deep hyperthermia twice to a specific lesion.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess adverse events and hyperthermia delivery for 90 days after the final deep hyperthermia treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06546969

Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer

Recruiting
PHASE1Ages 21+InterventionalTreatment
University of Maryland, Baltimore
~15 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:GemcitabineCisplatinDurvalumabSpatially Fractionated RTDeep Hyperthermia

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events assessment by CTCAE v5.0 that are grade 3 or higher and related to HT or SFRT
Measured over 90 days post final treatment of Deep Hyperthermia
+1 more outcome measured

Conditions

Biliary Tract Cancer
Cholangiocarcinoma

Explore related trials

CholangiocarcinomaGallbladder CarcinomaMalignant neoplasm of biliary tract

Where it's being run

2 sites across 1 states
Maryland2

Study leadership

  • Jason Molitoris, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland Medical Center / Maryland Proton Treatment Center

Who to contact

Jason Molitoris, MD, PhD
[email protected]
410-328-6080
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) 11. Life expectancy of at least 12 weeks at the time of screening 12. Body weight \>30 kg 13. Participants must provide a tumor biopsy taken within 3 years prior to screening 14. Baseline vitals: heart rate of ≤ 90bpm, systolic blood pressure of 140-100mmHg and diastolic of 90-60mmHg
Participants with grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician 12. Untreated brain metastases or spinal cord compression. Participants with suspected brain metastases at screening should have an MRI (preferred) or CT scan, each preferably with IV contrast of the brain prior to study entry 13. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients 14. Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment
Intranasal, inhaled, or topical steroids or local steroid injection
Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions 19. Participation in another clinical study with an investigational product administered in the last 3 months 20. Concurrent enrollment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study 21. Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to use effective birth control from screening to 180 days after the last dose of gemcitabine/cisplatin or 90 days after the last dose of durvalumab 22. Judgement by the investigator that the participant should not participate in the study if they are unlikely to comply with study procedures, restrictions, and requirements 23. Participants on anti-arrhythmic medication unless they are deemed fit for HT by a consultant cardiologist and there is no increased risk to the patient from HT because of the arrhythmia in the opinion of the treating physician 24. Severe COPD with FEV1 \< 50% of expected 25. Participants whose right-to-left pelvic/abdominal dimension is \> 49 cm 26. Participants with incorporated metallic implants such as metallic stents, pacemakers or defibrillators, and orthopedic rods and plates of dimensions \> 1000/frequency (MHz) aa. Participants who are under any therapy, which by virtue of direct pharmacological action or heat interaction, could influence the intended effects of HT or mask its side effects

Exclusion

Participants with vitiligo or alopecia
Participants with hypothyroidism stable on hormone replacement
Any chronic skin condition that does not requires systemic therapy
Participants without an active disease in the last 5 years may be included but only after consultation with the study physician
Participants with celiac disease controlled by diet alone 5. Known history or evidence of active, non-infectious pneumonitis 6. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase the risk of incurring adverse events, or compromise the ability of the participant to give written informed consent 7. Participants with documented myocardial infarction or cerebrovascular accident within 6 months prior to enrollment 8. History of another primary malignancy, except for:
Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product and of low potential risk for recurrence
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease 9. History of leptomeningeal carcinomatosis 10. Active infection including tuberculosis, hepatitis B or hepatitis C. Participants with a past or resolved hepatitis B infection or participants positive for hepatitis C antibody with negative hepatitis C virus RNA on polymerase chain reaction are eligible to enroll. Participants with HIV with undetectable viral load and CD4 cell count ≥200 cells/mm3 are eligible to enroll

What this trial measures

  • Number of adverse events assessment by CTCAE v5.0 that are grade 3 or higher and related to HT or SFRT90 days post final treatment of Deep Hyperthermia

    Determine the safety of combined deep hyperthermia, spatially-fractionated radiotherapy and chemoimmunotherapy in this patient population Safety is defined by \< 30% rate of grade 3 or higher non-hematologic adverse events possibly or probably related to deep HT or SFRT from cycle 2-day 1 until 90 days post the final deep HT treatment. A rolling safety evaluation will be performed during patient enrollment and termination of the study will occur if any of the below are met * Grade 3+ adverse events in more than 1 of the first 3 or 2 of the first 6 patients possibly or probably related to deep HT or SFRT * Grade 4+ adverse event in more than 3 total patients possibly or probably related to deep HT or SFRT * Grade 5 adverse event in 1 patient where the event is not clearly attributable to the underlying disease or extraneous causes.

  • 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 treatments90 days post final treatment

    Estimate the feasibility of administering combined deep hyperthermia, spatially-fractionated radiotherapy and chemoimmunotherapy for subjects with advanced biliary tract cancer not amenable to surgical resection or definitive local therapy. Feasibility is defined as the ability 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. A single-group design will be used to obtain a two-sided 95% confidence interval for a single proportion (feasibility). The Exact Clopper-Pearson approach will be used to calculate the confidence interval. The sample proportion is assumed to be 0.7. To produce a confidence interval with a width of no more than 0.5, 15 subjects will be needed.