RecruitingPhase 1NCT06546969

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

A Pilot Study of Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer


Sponsor

University of Maryland, Baltimore

Enrollment

15 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy, immunotherapy, hyperthermia (targeted heat treatment), and a special form of radiation therapy for people with advanced biliary tract cancer — which includes cancers of the bile ducts and gallbladder — that cannot be surgically removed. **You may be eligible if...** - You are 21 or older with confirmed unresectable (inoperable) or metastatic biliary tract cancer - You have not received prior systemic therapy for this advanced cancer (prior adjuvant treatment is allowed if finished at least 1 month before) - You are in reasonably good health (ECOG 0–2) - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have already received chemotherapy or immunotherapy for this advanced cancer - You have active autoimmune disease or are on immune-suppressing medications - You have serious uncontrolled heart, lung, or other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGemcitabine

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.

DRUGCisplatin

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.

DRUGDurvalumab

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.

RADIATIONSpatially Fractionated RT

Administered to 1 measurable lesion on cycle 2-day 1

DEVICEDeep Hyperthermia

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


Locations(2)

Maryland Proton Treatment Center

Baltimore, Maryland, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06546969


Related Trials