Actively Recruiting
Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
Led by University of Maryland, Baltimore · Updated on 2025-12-10
15
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent
- Signed and dated informed consent form before any study procedures
- Age 21 years or older at screening
- Histologically confirmed unresectable advanced or metastatic biliary tract cancer including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder carcinoma
- No prior systemic therapy for locally advanced, metastatic, or recurrent biliary tract cancer (prior adjuvant capecitabine allowed if last treatment was at least 1 month before enrollment)
- ECOG performance status of 0 to 2 at enrollment
- At least one measurable lesion in abdomen or pelvis suitable for spatially fractionated radiation therapy
- No prior use of gemcitabine or platinum chemotherapy
- No prior use of anti-PD1 or anti-PDL1 antibodies
- Adequate organ and marrow function as defined by hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.5 x 10⁹/L, platelet count ≥ 100 x 10⁹/L, bilirubin ≤ 2.5 x upper limit of normal, ALT and AST ≤ 3 x upper limit of normal, creatinine clearance > 50 mL/min
- Life expectancy of at least 12 weeks at screening
- Body weight greater than 30 kg
- Provide a tumor biopsy taken within 3 years before screening
- Baseline vital signs: heart rate ≤ 90 bpm, systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg
You will not qualify if you...
- Ampullary carcinoma
- History of allogeneic organ transplantation
- Prior radiation to proposed treatment site
- Active or prior autoimmune or inflammatory disorders except stable vitiligo, alopecia, hypothyroidism on hormone replacement, controlled celiac disease, or chronic skin conditions not requiring systemic therapy
- Known active non-infectious pneumonitis
- Uncontrolled illness including active infection, symptomatic heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active lung disease, serious gastrointestinal disease, or psychiatric/social issues limiting compliance
- Myocardial infarction or stroke within 6 months before enrollment
- History of other primary malignancy unless treated with curative intent and no active disease for 2 or more years, or adequately treated non-melanoma skin cancer or carcinoma in situ without evidence of disease
- History of leptomeningeal carcinomatosis
- Active infection including tuberculosis, hepatitis B or C (with exceptions), or HIV with undetectable viral load and adequate CD4 count
- Unresolved toxicity grade 2 or higher from previous cancer therapy except alopecia or vitiligo
- Untreated brain metastases or spinal cord compression
- Allergy or hypersensitivity to study drugs or excipients
- Concurrent chemotherapy or investigational cancer therapies (except hormonal therapy for non-cancer conditions)
- Receipt of live vaccine within 30 days before enrollment
- Major surgery within 28 days before enrollment
- Prior locoregional therapy with radioembolization
- Use of immunosuppressive medication within 14 days before first durvalumab dose except certain steroids
- Participation in another investigational study within last 3 months
- Concurrent enrollment in other interventional clinical studies unless observational or follow-up
- Pregnancy, breastfeeding, or unwillingness to use effective birth control during study
- Investigator judgment deeming participant unsuitable for study compliance or safety
- Use of anti-arrhythmic medication unless deemed safe for hyperthermia
- Severe COPD with lung function below 50%
- Pelvic/abdominal dimension greater than 49 cm
- Presence of metallic implants incompatible with hyperthermia or treatments
- Use of therapy that may interfere with hyperthermia effects or side effects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
J
Jason Molitoris, MD, PhD
CONTACT
C
Caitlin Eggleston
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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