OncoMatch/Clinical Trials/NCT06375915
Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy
Is NCT06375915 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06375915 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages