Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients

Sponsor
UNICANCER
Study ID
NCT06529718
Phase
PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • Ivonescimab — DRUG
    20 mg/kg IV infusion every 3 weeks
  • FOLFOX regimen — DRUG
    oxaliplatin 85 mg/m² IV, leucovorin 200 mg/m² IV (or folinic acid 400 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m² as a 46 hour continuous IV infusion, every 2 weeks

Study Details

The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment. Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

Key Dates

Start date
Oct 9, 2025
Status verified
Oct 2025
Primary completion
Aug 3, 2027
Completion
Jan 30, 2029

Study Design

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

Arms

  • Experimental: Experimental
    Experimental treatment under study
  • Active Comparator: Control
    Standard of care second-line treatment for advanced biliary tract cancer

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From randomisation to disease progression or death, up to 4 years ]

Central Contacts

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