Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
A Randomised, Phase II Trial to Evaluate the Efficacy of Ivonescimab, a PD 1/VEGF Bispecific Antibody, Versus FOLFOX as Second Line Therapy for Locally Advanced/Metastatic Biliary Cancers
Sponsor: UNICANCER + Cancer Research UK & UCL Cancer Trials Centre, Belgian Group of Digestive Oncology
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free survival (PFS)
Time frame: From randomisation to disease progression or death, up to 4 years
Secondary Endpoints
Overall Survival (OS)
Objective response rate
Disease control rate
Eligibility Criteria
Inclusion Criteria: 1. Signed a written informed consent form prior to any trial specific procedures. 2. Histologically-proven intrahepatic cholangiocarcinoma, perihilar / distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded). 3. Locally advanced (non-resectable) or metastatic disease. 4. Participated in the Screening phase of the SAFIR-ABC10 trial. 5. Progression after first line standard of care (1L-SoC) regimen (CISGEM ± immunotherapy) as assessed by the investigator. 6. Eligible for second-line treatment with FOLFOX. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Presence of at least one evaluable lesion according to RECIST v1.1. 9. Age ≥18 years. 10. Adequate bone marrow function: absolute neutrophil count (ANC) ≥2 × 10⁹/L, platelet count ≥100 × 10⁹/L, and haemoglobin ≥9 g/dL. Note: Blood transfusion or growth factor therapy should not be performed within 7 days prior to the screening haematology analysis. 11. Adequ…
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