protocolSection identificationModule nctId: NCT06375915, orgStudyIdInfo id: PM-CARE, secondaryIdInfos id: PNRR-MAD-2022-12375905, type: OTHER_GRANT, domain: Italian Ministry of Health, briefTitle: Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy, acronym: PM-CARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Francesco De Cobelli, class: OTHER, collaborators name: Cardarelli Hospital, collaborators name: A.O. Ospedale Papa Giovanni XXIII, collaborators name: AOU Pisana, Pisa, Italy, descriptionModule briefSummary: Underlying disease mechanisms are fundamental for correct treatment selection and patient management in highly invasive and debilitating non-transmissible diseases. Even though overall disease burden of cancer may have decreased due to a higher degree of awareness, the availability of high-quality healthcare and early diagnosis may become challenging in certain neoplasms. Cholangiocarcinoma is usually diagnosed at advanced stages due to non-specific presentation and is frequently refractory to chemotherapy, causing a massive impact on patients and their families. Surgery is currently the only curative treatment but is available to only approximately 30% of patients. The combination of interventional- and immune-oncology to standard of care creates the perfect substrate for synergistic mechanisms to fight tumor growth; in situ cell death following transarterial embolization(TARE) elicits immune mediated response, inflammatory response and biomarkers of oxidative stress and increases antigen presenting T-cells which an anti-anti progam death ligand (PD-L)1 can bind to; standard of care can then add on with its known effects.The rationale of a combined- locoregional and systemic - treatment lies in the synergistic effects of each of the treatments., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: radioembolization with Y-90, interventions name: Durvalumab, interventions name: Cisplatin, interventions name: Gemcitabine, outcomesModule primaryOutcomes measure: Overall response rate (ORR), primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, secondaryOutcomes measure: Median progression free survival, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Tumor circulating markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor circulating markers, secondaryOutcomes measure: Tumor tissue based evaluation, secondaryOutcomes measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Quantitative imaging based biomarkers, secondaryOutcomes measure: Quantitative biomarkers, secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Radiology, IRCCS Ospedale San Raffaele, city: Milano, zip: 20132, country: Italy, contacts name: Francesco De Cobelli, MD, role: CONTACT, phone: +39022643, phoneExt: 2529, email: decobelli.francesco@hsr.it, contacts name: Stephanie Steidler, PhD, role: CONTACT, phone: +39022643, phoneExt: 6111, email: steidler.stephanie@hsr.it, contacts name: Francesco De Cobelli, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Ratti, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False