nctId: NCT06375915 id: PM-CARE 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 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-04-19 date: 2024-04-19 name: Francesco De Cobelli class: OTHER name: Cardarelli Hospital name: A.O. Ospedale Papa Giovanni XXIII name: AOU Pisana, Pisa, Italy 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. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: radioembolization with Y-90 name: Durvalumab name: Cisplatin name: Gemcitabine measure: Overall response rate (ORR) measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Median progression free survival measure: Overall response rate measure: Overall response rate measure: Overall response rate measure: Overall response rate measure: Tumor circulating markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor circulating markers measure: Tumor tissue based evaluation measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Quantitative imaging based biomarkers measure: Quantitative biomarkers measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiology, IRCCS Ospedale San Raffaele city: Milano zip: 20132 country: Italy name: Francesco De Cobelli, MD role: CONTACT phone: +39022643 phoneExt: 2529 email: decobelli.francesco@hsr.it name: Stephanie Steidler, PhD role: CONTACT phone: +39022643 phoneExt: 6111 email: steidler.stephanie@hsr.it name: Francesco De Cobelli, MD role: PRINCIPAL_INVESTIGATOR name: Francesca Ratti, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False