OncoMatch/Clinical Trials/NCT06546969
Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
Is NCT06546969 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Gemcitabine and Cisplatin for biliary tract cancer.
Treatment: Gemcitabine · Cisplatin · Durvalumab · Deep Hyperthermia — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: gemcitabine
No prior exposure to gemcitabine
Cannot have received: platinum-based chemotherapy
No prior exposure to ... platinum-based chemotherapy
Cannot have received: anti-PD-1 therapy
No prior exposure to anti-PD1 or anti-PDL1 antibodies
Cannot have received: anti-PD-L1 therapy
No prior exposure to anti-PD1 or anti-PDL1 antibodies
Cannot have received: adjuvant capecitabine
Exception: allowed as long as last treatment was ≥ 1 month before enrollment
prior adjuvant capecitabine therapy is allowed as long as last treatment was ≥ 1 month before enrollment
Cannot have received: radiation therapy
Exception: prior history of radiation to the proposed treatment site excluded
Prior history of radiation to the proposed treatment site
Cannot have received: radioembolization
Prior locoregional therapy with radioembolization
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L
Kidney function
Measured or calculated creatinine clearance > 50 mL/min as determined by Cockcroft-Gault (using actual body weight)
Liver function
Serum bilirubin ≤ 2.5 x ULN; ALT and AST ≤ 3 x ULN
Cardiac function
Baseline vitals: heart rate ≤ 90 bpm, systolic blood pressure 140-100 mmHg, diastolic 90-60 mmHg
Adequate organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Serum bilirubin ≤ 2.5 x ULN; ALT and AST ≤ 3 x ULN; Measured or calculated creatinine clearance > 50 mL/min; Baseline vitals: heart rate ≤ 90bpm, systolic blood pressure of 140-100mmHg and diastolic of 90-60mmHg
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Maryland Proton Treatment Center · Baltimore, Maryland
- University of Maryland Greenebaum Cancer Center · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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