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New treatment option for Bile Duct Cancer
Official title Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
ClinicalTrials.gov ID: NCT05655949
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 bile duct cancer.
Also referred to as Gemzar.
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 trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery. The specific names of the interventions that will be used are: Y-90 (a type of radiation microsphere bead) Durvalumab (a type of immunotherapy) Gemcitabine (a type of chemotherapy) Cisplatin (a type of chemotherapy)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to comprehend and willingness to sign a written ICF for the study
- Male and female participants at least 18 years of age at the time of signing the ICF
- Histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma; at least one intrahepatic...
- Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria
- ECOG performance status ≤1
You likely can't join if
- Surgically resectable disease at enrollment
- Histologically or cytologically confirmed diagnosis of primary hepatocellular carcinoma or mixed adenocarcinoma/hepatocellular carcinoma
- Received prior systemic chemotherapy and/or radiotherapy for intrahepatic cholangiocarcinoma. Prior surgical resection and adjuvant chemotherapy or...
- Prior treatment with anti-PD-1, anti-PD-L, including durvalumab antibody, or any other drug treatment specifically targeting T-cell co-stimulation or...
- Any of the following within 6 months of screening:
- New York Heart Association (NYHA) Class III or IV heart failure
See the full eligibility criteria
Who can join
- Ability to comprehend and willingness to sign a written ICF for the study
- Male and female participants at least 18 years of age at the time of signing the ICF
- Histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma; at least one intrahepatic lesion must be present
- Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria
- ECOG performance status ≤1
- Body weight \>30 kg
- Must have a life expectancy of at least 12 weeks
- Participants must have adequate marrow function as defined below:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1.0 × 109 /L
- Platelet count ≥75 × 109/L
- Participants must have adequate renal function as defined below:
- Serum creatinine ≤ 1.5 mg/dL OR
- Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
- Participants must have adequate hepatic function as defined below:
- Bilirubin ≤1.5 x ULN
- ALT ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN
- AST ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN
- This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed...
- No known history of active HBV or HCV infection.
- Note: Participants with Hepatitis C who have been clinically cured, defined as persistent absence of Hepatitis C RNA detected by polymerase chain reaction (PCR) test in serum 12 weeks after completing antiviral...
- Note: Participants with a history of Hepatitis B infection that are currently on viral suppressive therapy are eligible for enrollment
- Adequate coagulation studies as demonstrated by prothrombin (PT) and partial thromboplastin (PTT) time within normal limits (\</= 1.5 x ULN) in the absence of anticoagulation medication. Participants receiving...
- Participants with known human immunodeficiency virus (HIV) on effective highly-active antiretroviral therapy (HAART) with undetectable viral load within 6 months are eligible for this trial, so long as the following...
- HAART does not interact with or have overlapping toxicities with study medication, per discretion of the treating provider
- CD4 count is ≥350 cells/uL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications
- Probable long-term survival with HIV if cancer were not present
- Stable on a HAART regimen for ≥4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study
- HIV is not multi-drug resistant
- Taking medication and/or receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication
What rules you out
- Surgically resectable disease at enrollment
- Histologically or cytologically confirmed diagnosis of primary hepatocellular carcinoma or mixed adenocarcinoma/hepatocellular carcinoma
- Received prior systemic chemotherapy and/or radiotherapy for intrahepatic cholangiocarcinoma. Prior surgical resection and adjuvant chemotherapy or chemoradiotherapy is allowed if more than 6 months have elapsed since...
- Prior treatment with anti-PD-1, anti-PD-L, including durvalumab antibody, or any other drug treatment specifically targeting T-cell co-stimulation or checkpoint pathways
- Any of the following within 6 months of screening:
- New York Heart Association (NYHA) Class III or IV heart failure
- Myocardial infarction, unstable angina pectoris, or symptomatic coronary artery disease
- Unstable arrhythmia
- Stroke to transient ischemic attack
- Previous malignancies, except for adequately treated non-melanoma skin cancer, in-situ cancer, or any other cancer from which the subject has been disease-free for at least 3 years
- Severe chronic obstructive or other pulmonary disease with chronic baseline hypoxemia due to potential for gemcitabine-induced bronchospasm and/or durvalumab-induced pneumonitis
- Major surgery (other than diagnostic) within 4 weeks of study treatment day 1
- Active, uncontrolled or untreated bacterial, viral, or fungal infection that requires systemic therapy
- Active, untreated HIV, HBV, or HCV
- people who have participated in another investigational drug or device study within 4 weeks prior to study registration. Pregnant women are excluded from this study because cisplatin is a class D agent with the...
- Female patients of child-bearing potential Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non sterilized male partner must use at least 1 highly effective method...
- Male patients with a female partner of childbearing potential Non-sterilized male patients who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom...
- Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses...
- Copper T intrauterine device
- Levonorgestrel-releasing intrauterine system (e.g., Mirena®)a
- Implants: Etonogestrel-releasing implants: e.g. Implanon® or Norplant®
- Intravaginal: Ethinylestradiol/etonogestrel-releasing intravaginal devices: e.g. NuvaRing®
- Injection: Medroxyprogesterone injection: e.g. Depo-Provera®
- Combined Pill: Normal and low dose combined oral contraceptive pill
- Patch: Norelgestromin/ethinylestradiol-releasing transdermal system: e.g. Ortho Evra® Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette® is currently the only highly effective...
- Any concomitant disease or condition that could interfere with the conduct of the study, or that would in the option of the investigator pose an unacceptable risk to the subject in the study
- Contraindications to Y-90 SIRT per assessment by treating treatment Radiologist (eg significant vascular drainage of the tumor to the lung that increases the potential for pulmonary toxicity)
- Unwillingness or inability to comply with the study protocol
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus...
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- History of active primary immunodeficiency
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed \ \> of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab...
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 52 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, 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.