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

PHASE1RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 29, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Biliary Tract CancerCholangiocarcinoma
Interventions
DRUG

Gemcitabine

1000mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles. After the 16 weeks of trial participation, participants will continue chemoimmunotherapy per standard of care.

DRUG

Cisplatin

25mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles. After the 16 weeks of trial participation, participants will continue chemoimmunotherapy per standard of care.

DRUG

Durvalumab

1500mg via intravenous infusion on day 1 of every 21-day cycle for up to 8 cycles. After the 16 weeks of trial participation, participants will continue chemoimmunotherapy per standard of care.

RADIATION

Spatially Fractionated RT

Administered to 1 measurable lesion on cycle 2-day 1

DEVICE

Deep Hyperthermia

Deep hyperthermia alone will be delivered to the same lesion on cycle 3-day 1 and cycle 4-day 1

Trial Locations (2)

21201

RECRUITING

Maryland Proton Treatment Center, Baltimore

RECRUITING

University of Maryland Greenebaum Cancer Center, Baltimore

All Listed Sponsors
lead

University of Maryland, Baltimore

OTHER