Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients

Exclusion criteria

• . Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events \[NCI-CTCAE v5.0\]) before randomisation with the exception of alopecia.
• . Received first-line maintenance therapy with a matched target therapy proposed in SAFIR ABC10, or any second-line treatment.
• . Contraindication to ivonescimab.
• . Proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).
• . Treatment with brivudine, sorivudine or their chemical analogues in the 4 weeks prior to randomisation.
• . Major surgical procedures or serious trauma within 4 weeks prior to randomisation, or plans for major surgery within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterisation and port implantation) within 3 days prior to randomisation.
• . History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomisation, including but not limited to:
• . Gastrointestinal bleeding.