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RECRUITING
NCT06375915
PHASE2

Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy

Sponsor: Francesco De Cobelli

View on ClinicalTrials.gov

Summary

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.

Official title: Single Arm, Multicenter Phase II Study Investigating the Efficacy and Safety of a Novel Therapeutic Scheme in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization in Combination With CisGem and Durvalumab (MEDI4736)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2024-04-30

Completion Date

2027-05

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

RADIATION

radioembolization with Y-90

Radioembolization with Y-90 will be performed in nominal day 0

DRUG

Durvalumab

Following radioembolization, for 6 cycles -intravenous infusion on day 1 of each cycle

DRUG

Cisplatin

Following radioembolization, for 6 cycles -intravenous infusion on day 1 and 8 of each cycle

DRUG

Gemcitabine

Following radioembolization, for 6 cycles -intravenous infusion on day 1 and 8 of each cycle

Locations (4)

ASST Papa Giovanni XXIII

Bergamo, Italy

Department of Radiology, IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

Naples, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy