Biliary Tract CancerPhase 1NCT06546969
Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
A Phase 1 study testing Gemcitabine, Cisplatin and Durvalumab in people with Biliary Tract Cancer and Cholangiocarcinoma, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Biliary Tract Cancer, Cholangiocarcinoma
- What is being tested?
- Gemcitabine, Cisplatin and Durvalumab
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2024to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Provision of a signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses
- Age ≥ 21 years at the time of screening
- Histologically-confirmed, unresectable advanced or metastatic carcinoma of the biliary tract including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder carcinoma
- No prior systemic therapy for locally advanced, metastatic, or recurrent BTC (prior adjuvant capecitabine therapy is allowed as long as last treatment was ≥ 1 month before enrollment)
- An ECOG performance status of 0-2 at enrollment
Show all 20Show fewer
- At least 1 lesion that qualifies as a RECIST version 1.1 target lesion in the abdomen or pelvis that is amenable to SFRT on contrast enhanced CT or MRI
- No prior exposure to gemcitabine or platinum-based chemotherapy
- No prior exposure to anti-PD1 or anti-PDL1 antibodies
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL
- ANC ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Serum bilirubin ≤ 2.5 x upper limit of normal (ULN)
- Alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN
- Measured creatinine clearance > 50 mL/min or calculated creatinine clearance > 50 mL/min as determined by Cockcroft-Gault (using actual body weight)
- Life expectancy of at least 12 weeks at the time of screening
- Body weight >30 kg
- Participants must provide a tumor biopsy taken within 3 years prior to screening
- Baseline vitals: heart rate of ≤ 90bpm, systolic blood pressure of 140-100mmHg and diastolic of 90-60mmHg
Who cannot join
- Ampullary carcinoma
- History of allogeneic organ transplantation
- Prior history of radiation to the proposed treatment site
- Active or prior documented autoimmune or inflammatory disorders with the following exceptions:
- Participants with vitiligo or alopecia
- Participants with hypothyroidism stable on hormone replacement
Show all 40Show fewer
- Any chronic skin condition that does not requires systemic therapy
- Participants without an active disease in the last 5 years may be included but only after consultation with the study physician
- Participants with celiac disease controlled by diet alone
- Known history or evidence of active, non-infectious pneumonitis
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase the risk of incurring adverse events, or compromise the ability of the participant to give written informed consent
- Participants with documented myocardial infarction or cerebrovascular accident within 6 months prior to enrollment
- History of another primary malignancy, except for:
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of leptomeningeal carcinomatosis
- Active infection including tuberculosis, hepatitis B or hepatitis C. Participants with a past or resolved hepatitis B infection or participants positive for hepatitis C antibody with negative hepatitis C virus RNA on polymerase chain reaction are eligible to enroll. Participants with HIV with undetectable viral load and CD4 cell count ≥200 cells/mm3 are eligible to enroll
- Any unresolved toxicity per CTCAE version 5.0 grade ≥2 from a previous anticancer therapy, except for alopecia, vitiligo and the laboratory values defined in the inclusion criteria.
- Participants with grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
- Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician
- Untreated brain metastases or spinal cord compression. Participants with suspected brain metastases at screening should have an MRI (preferred) or CT scan, each preferably with IV contrast of the brain prior to study entry
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment
- Concurrent use of hormonal therapy for non-cancer related conditions is acceptable
- Receipt of live attenuated vaccine within 30 days prior to the enrollment
- Major surgical procedure within 28 days prior to enrollment.
- Prior locoregional therapy with radioembolization
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab with the following exceptions:
- Intranasal, inhaled, or topical steroids or local steroid injection
- Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions
- Participation in another clinical study with an investigational product administered in the last 3 months
- Concurrent enrollment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study
- Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to use effective birth control from screening to 180 days after the last dose of gemcitabine/cisplatin or 90 days after the last dose of durvalumab
- Judgement by the investigator that the participant should not participate in the study if they are unlikely to comply with study procedures, restrictions, and requirements
- Participants on anti-arrhythmic medication unless they are deemed fit for HT by a consultant cardiologist and there is no increased risk to the patient from HT because of the arrhythmia in the opinion of the treating physician
- Severe COPD with FEV1 < 50% of expected
- Participants whose right-to-left pelvic/abdominal dimension is > 49 cm
- Participants with incorporated metallic implants such as metallic stents, pacemakers or defibrillators, and orthopedic rods and plates of dimensions > 1000/frequency (MHz) aa. Participants who are under any therapy, which by virtue of direct pharmacological action or heat interaction, could influence the intended effects of HT or mask its side effects
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Caitlin Eggleston, 410-369-7586, caitlineggleston@umm.edu
- Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Caitlin Eggleston, BS, 4103287586, caitlineggleston@umm.edu
About this study
Official title: A Pilot Study of 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 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.
Read more
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
- Biliary Tract Cancer, Cholangiocarcinoma
- Being tested
- Gemcitabine, Cisplatin, Durvalumab, Spatially Fractionated RT, Deep Hyperthermia
- Keywords
- Chemoimmunotherapy, Spatially Fractionated Radiation Therapy, Deep Hyperthermia
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
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.
CisplatinDrug
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.
DurvalumabDrug
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.
Spatially Fractionated RTRadiation
Administered to 1 measurable lesion on cycle 2-day 1
Deep HyperthermiaDevice
Deep hyperthermia alone will be delivered to the same lesion on cycle 3-day 1 and cycle 4-day 1
| Study group | Role | What they receive |
|---|---|---|
| Chemoimmunotherapy + SFRT + Deep Hyperthermia | Experimental | 1. Gemcitabine 1000mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles
2. Cisplatin 25mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles
3. Durvalumab 1500mg via intravenous infusion on day 1 of every 21-day cycle for up to 8 cycles
4. Deep hyperthermia and spatially-fractionated radiotherapy will be administered to 1 measurable lesion on cycle 2-day 1 and deep hyperthermia alone will be delivered to the same lesion on cycle 3-day 1 and cycle 4-day 1 Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Durvalumab; Radiation: Spatially Fractionated RT; Device: Deep Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events assessment by CTCAE v5.0 that are grade 3 or higher and related to HT or SFRT
Determine the safety of combined deep hyperthermia, spatially-fractionated radiotherapy and chemoimmunotherapy in this patient population
Safety is defined by < 30% rate of grade 3 or higher non-hematologic adverse events possibly or probably related to deep HT or SFRT from cycle 2-day 1 until 90 days post the final deep HT treatment. A rolling safety evaluation will be performed during patient enrollment and termination of the study will occur if any of the below are met
- Grade 3+ adverse events in more than 1 of the first 3 or 2 of the first 6 patients possibly or probably related to deep HT or SFRT
- Grade 4+ adverse event in more than 3 total patients possibly or probably related to deep HT or SFRT
- Grade 5 adverse event in 1 patient where the event is not clearly attributable to the underlying disease or extraneous causes.
Measured: 90 days post final treatment of Deep Hyperthermia
Number of participants to receive a minimum of 30 minutes of heating at target temperature (39-43°C) for at least 2 of the planned 3 deep HT treatments
Estimate the feasibility of administering combined deep hyperthermia, spatially-fractionated radiotherapy and chemoimmunotherapy for subjects with advanced biliary tract cancer not amenable to surgical resection or definitive local therapy.
Feasibility is defined as the ability of participants to receive a minimum of 30 minutes of heating at target temperature (39-43°C) for at least 2 of the planned 3 deep HT treatments. A single-group design will be used to obtain a two-sided 95% confidence interval for a single proportion (feasibility). The Exact Clopper-Pearson approach will be used to calculate the confidence interval. The sample proportion is assumed to be 0.7. To produce a confidence interval with a width of no more than 0.5, 15 subjects will be needed.
Measured: 90 days post final treatment
Secondary outcomes (1)
Radiographic Response Rate
Estimate the radiographic response rate at the 16 week imaging timepoint.
All participants who undergo at least 1 imaging assessment after beginning study will be eligible for radiographic response estimation per RECIST version 1.1 by local radiology review. Baseline CT or MRI scans will be used to select target and non-target lesions.
Measured: 16 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start29 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Molitoris, MD PhD, University of Maryland, Baltimore
- Investigators
- Jason Molitoris, MD, PhD, Principal investigator, University of Maryland Medical Center / Maryland Proton Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546969
- Sponsor's protocol ID
- HP-00109947
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06546969
- Acronym / sponsor ID
- HP-00109947
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma
- Keywords
- Chemoimmunotherapy, Spatially Fractionated Radiation Therapy, Deep Hyperthermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoimmunotherapy + SFRT + Deep Hyperthermia | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Drug: Durvalumab, Radiation: Spatially Fractionated RT, Device: Deep Hyperthermia1. Gemcitabine 1000mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles 2. Cisplatin 25mg/m2 via intravenous infusion on days 1 and 8 of every 21-day cycle for up to 8 cycles 3. Durvalumab 1500mg via intravenous infusion on day 1 of every 21-day cycle for up to 8 cycles 4. Deep hyperthermia and spatially-fractionated radiotherapy will be administered to 1 measurable lesion on cycle 2-day 1 and deep hyperthermia alone will be delivered to the same lesion on cycle 3-day 1 and cycle 4-day 1 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Provision of a signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses
- Age ≥ 21 years at the time of screening
- Histologically-confirmed, unresectable advanced or metastatic carcinoma of the biliary tract including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder carcinoma
- No prior systemic therapy for locally advanced, metastatic, or recurrent BTC (prior adjuvant capecitabine therapy is allowed as long as last treatment was ≥ 1 month before enrollment)
Key exclusion criteria (40 listed)
- Ampullary carcinoma
- History of allogeneic organ transplantation
- Prior history of radiation to the proposed treatment site
- Active or prior documented autoimmune or inflammatory disorders with the following exceptions:
- Known history or evidence of active, non-infectious pneumonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine1000mg/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 | Chemoimmunotherapy + SFRT + Deep Hyperthermia |
| Cisplatin25mg/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 | Chemoimmunotherapy + SFRT + Deep Hyperthermia |
| Durvalumab1500mg 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. | Drug | Chemoimmunotherapy + SFRT + Deep Hyperthermia |
| Spatially Fractionated RTAdministered to 1 measurable lesion on cycle 2-day 1 | Radiation | Chemoimmunotherapy + SFRT + Deep Hyperthermia |
| Deep HyperthermiaDeep hyperthermia alone will be delivered to the same lesion on cycle 3-day 1 and cycle 4-day 1 | Device | Chemoimmunotherapy + SFRT + Deep Hyperthermia |
Primary outcome
Number of adverse events assessment by CTCAE v5.0 that are grade 3 or higher and related to HT or SFRT
Time frame: 90 days post final treatment of Deep Hyperthermia
Determine the safety of combined deep hyperthermia, spatially-fractionated radiotherapy and chemoimmunotherapy in this patient population Safety is defined by < 30% rate of grade 3 or higher non-hematologic adverse events possibly or probably related to deep HT or SFRT from cycle 2-day 1 until 90 days post the final deep HT treatment. A rolling safety evaluation will be performed during patient enrollment and termination of the study will occur if any of the below are met * Grade 3+ adverse events in more than 1 of the first 3 or 2 of the first 6 patients possibly or probably related to deep HT or SFRT * Grade 4+ adverse event in more than 3 total patients possibly or probably related to deep HT or SFRT * Grade 5 adverse event in 1 patient where the event is not clearly attributable to the underlying disease or extraneous causes.
Number of participants to receive a minimum of 30 minutes of heating at target temperature (39-43°C) for at least 2 of the planned 3 deep HT treatments
Time frame: 90 days post final treatment
Estimate the feasibility of administering combined deep hyperthermia, spatially-fractionated radiotherapy and chemoimmunotherapy for subjects with advanced biliary tract cancer not amenable to surgical resection or definitive local therapy. Feasibility is defined as the ability of participants to receive a minimum of 30 minutes of heating at target temperature (39-43°C) for at least 2 of the planned 3 deep HT treatments. A single-group design will be used to obtain a two-sided 95% confidence interval for a single proportion (feasibility). The Exact Clopper-Pearson approach will be used to calculate the confidence interval. The sample proportion is assumed to be 0.7. To produce a confidence interval with a width of no more than 0.5, 15 subjects will be needed.
1 secondary outcome
Radiographic Response Rate
Time frame: 16 weeks from start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Molitoris, MD, PhD principal investigator
University of Maryland Medical Center / Maryland Proton Treatment Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, Cisplatin and Durvalumab in people with Biliary Tract Cancer and Cholangiocarcinoma, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Molitoris, MD, PhD (410-328-6080, JMolitoris@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events assessment by CTCAE v5.0 that are grade 3 or higher and related to HT or SFRT (time frame: 90 days post final treatment of Deep Hyperthermia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.