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

NCT06375915 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-05-24

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholangiocarcinoma

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

Sponsors & Collaborators

  • Cardarelli Hospital

    collaborator OTHER

  • A.O. Ospedale Papa Giovanni XXIII

    collaborator OTHER

  • AOU Pisana, Pisa, Italy

    collaborator UNKNOWN

  • Francesco De Cobelli

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375915 on ClinicalTrials.gov