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

Sponsor
Francesco De Cobelli
Study ID
NCT06375915
Phase
PHASE2
Status
Unknown

Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • radioembolization with Y-90 — RADIATION
    Radioembolization with Y-90 will be performed in nominal day 0
  • Durvalumab — DRUG
    Following radioembolization, for 6 cycles -intravenous infusion on day 1 of each cycle
  • Cisplatin — DRUG
    Following radioembolization, for 6 cycles -intravenous infusion on day 1 and 8 of each cycle
  • Gemcitabine — DRUG
    Following radioembolization, for 6 cycles -intravenous infusion on day 1 and 8 of each cycle

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
May 2024
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tretament arm
    Single arm treatment

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 6 months post TARE ]

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