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NCT06546969 · ClinicalTrials.gov registry record · Phase 1
Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
A Phase 1 study of Cholangiocarcinoma and Biliary Tract Cancer, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT06546969 is a Phase 1 study of Cholangiocarcinoma and Biliary Tract Cancer that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 15 participants, below the 386-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06546969, a Phase 1 study of Cholangiocarcinoma and Biliary Tract Cancer, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Durvalumab
- RADIATION Spatially Fractionated RT
- DEVICE Deep Hyperthermia
Study Locations (2)
Maryland
- Maryland Proton Treatment Center - Baltimore
- University of Maryland Greenebaum Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06546969
The ClinicalTrials.gov registry entry for NCT06546969 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 386-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (96% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT06546969 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06546969 about?
NCT06546969 is a clinical study titled "Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer". 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 ...
What is the current status of trial NCT06546969?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-10-29. Estimated completion is 2028-12.
What conditions does trial NCT06546969 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Biliary Tract Cancer.
What interventions are being tested in trial NCT06546969?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Durvalumab (DRUG), Spatially Fractionated RT (RADIATION), Deep Hyperthermia (DEVICE).
Who is sponsoring clinical trial NCT06546969?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06546969 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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