Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT04238637
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous Infusion)
  • Tremelimumab — DRUG
    Tremelimumab IV (intravenous Infusion)

Study Details

A multicenter Phase II, randomized, prospective, open-label Trial investigating the clinical impact on combining Specific Internal Radiotherapy (SIRT) with the PD1-L Inhibitor Durvalumab and the CTLA-4 Inhibitor Tremelimumab in patients with intrahepatic Biliary Tract Cancer

Key Dates

Start date
Nov 1, 2019
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Durvalumab
  • Experimental: Arm 2
    Durvalumab in combination with Tremelimumab

Primary Outcome Measure

Objective Response rate (ORR) according to RECIST 1.1 [ Time Frame: 20 months ]

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