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New treatment option for Biliary Tract Cancer
Official title Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT06546969
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
- 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...
- No prior systemic therapy for locally advanced, metastatic, or recurrent BTC (prior adjuvant capecitabine therapy is allowed as long as last...
You likely can't join if
- 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
See the full eligibility criteria
Who can 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
- 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
What rules you out
- 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
- 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...
- 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...
- 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...
- 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 treatment 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.