OncoMatch/Clinical Trials/NCT06375915
Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy
Is NCT06375915 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Cisplatin for intrahepatic cholangiocarcinoma.
Treatment: Durvalumab · Cisplatin · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
not previously treated with systemic or surgical therapies
Cannot have received: surgical therapy
not previously treated with systemic or surgical therapies
Cannot have received: investigational product
not previously enrolled in another clinical study with an investigational product
Cannot have received: durvalumab (durvalumab)
Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
Lab requirements
Blood counts
Hemoglobin ≥9 g/dL, platelet count ≥75,000/mm3, absolute neutrophil count (ANC) ≥ 1.0 x 10^9 /L
Kidney function
serum creatinine <2x ULN and eGFR ≥30ml/min/1.73m2; measured creatinine clearance (CL) >40 mL/min or calculated creatinine CL >40 mL/min by Cockcroft-Gault or 24-hour urine collection
Liver function
Child Pugh Class A; MELD <10; FLR uptake function ≥2.7%/min/m2 on technetium-99m mebrofenin hepatobiliary scintigraphy and FLR volume >30% of total functional liver volume for a normal liver, or >40% if the liver has been damaged; ALP, ALT and/or AST ≤ 5x ULN; total bilirubin ≤ 1.5x ULN (except Gilbert's syndrome in consultation with physician)
Cardiac function
Adequate heart function; Mean QTcF <470 ms (from 3 ECGs within 15 minutes at 5 minutes apart)
Preserved liver function as defined as: Child Pugh Class A; MELD <10; FLR uptake function ≥2.7%/min/m2... Adequate heart and lung function; serum creatinine <2x ULN and eGFR ≥30ml/min/1.73m2; measured creatinine clearance (CL) >40 mL/min... ALP, ALT and/or AST ≤ 5x ULN and total bilirubin ≤ 1.5 x ULN... Hemoglobin ≥9 g/dL, platelet count ≥75,000/mm3, ANC ≥ 1.0 x 10^9 /L; Mean QTcF <470 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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