RecruitingPhase 2NCT06375915

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

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)


Sponsor

Francesco De Cobelli

Enrollment

33 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a precision treatment approach for a type of bile duct cancer (intrahepatic cholangiocarcinoma) that mainly affects the liver — combining radioactive bead therapy (radioembolization) with targeted drugs to improve outcomes. **You may be eligible if...** - You are between 18 and 80 years old and weigh more than 30 kg - You have intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) that has not yet been treated - Your cancer is mainly confined to the liver - You have a high calculated risk of early recurrence **You may NOT be eligible if...** - You have already received systemic or surgical treatment for this cancer - Your cancer has spread significantly outside the liver - You have other conditions that would make the treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONradioembolization with Y-90

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

DRUGDurvalumab

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

DRUGCisplatin

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

DRUGGemcitabine

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


Locations(4)

ASST Papa Giovanni XXIII

Bergamo, Bg, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Pi, Italy

Department of Radiology, IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

Naples, Italy

View Full Details on ClinicalTrials.gov

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NCT06375915


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