Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05655949
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bile Duct Cancer
  • Cholangiocarcinoma
  • Cholangiocarcinoma Metastatic
  • Cholangiocarcinoma Non-resectable
  • Metastatic Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Intravenous infusion
  • Cisplatin — DRUG
    Intravenous infusion
  • Durvalumab — DRUG
    Intravenous infusion
  • Yttrium-90 — RADIATION
    Injection of radiation microsphere beads

Study Details

This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery. The specific names of the interventions that will be used are: * Y-90 (a type of radiation microsphere bead) * Durvalumab (a type of immunotherapy) * Gemcitabine (a type of chemotherapy) * Cisplatin (a type of chemotherapy)

Key Dates

Start date
Feb 13, 2024
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: Gemcitabine + Cisplatin + Durvalumab + Yttrium-90 Selective Internal Radiation Therapy
    Participants will receive: * Cycle 1: Day 1 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy) plus Durvalumab (immunotherapy). Day 8 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy) Week 2 or 3 of 21 Day Cycle: One time treatment of Y-90 radiation. * Cycles 2-8: Day 1 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy) plus Durvalumab (immunotherapy). Day 8 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy) * Cycles 9+: Day 1 of 21 Day Cycle: Durvalumab (immunotherapy) maintenance

Primary Outcome Measure

Median Progression Free Survival (PFS) [ Time Frame: Enrollment to end of treatment and up to 52 weeks thereafter ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Andrea Bullock, MD, MPH
[email protected]
617-667-2100
Andrea Bullock, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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