OncoMatch/Clinical Trials/NCT06529718
Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
Official title: 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
Is NCT06529718 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Ivonescimab and FOLFOX regimen for biliary tract cancer.
Treatment: Ivonescimab · FOLFOX regimen — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (cisplatin, gemcitabine) — first-line
Progression after first line standard of care (1L-SoC) regimen (CISGEM ± immunotherapy) as assessed by the investigator
Cannot have received: matched targeted therapy
Received first-line maintenance therapy with a matched target therapy proposed in SAFIR ABC10, or any second-line treatment
Cannot have received: second-line treatment
Received...any second-line treatment
Lab requirements
Blood counts
ANC ≥2 × 10⁹/L, platelet count ≥100 × 10⁹/L, haemoglobin ≥9 g/dL (no transfusion/growth factor within 7 days prior to screening)
Kidney function
estimated creatinine clearance ≥50 mL/min (Cockcroft-Gault or CKD-EPI), urine protein < 2+ or 24h urine protein < 1.0 g
Liver function
total bilirubin ≤1.5 × ULN (≤3 x ULN for patients with liver metastases or Gilbert syndrome), AST and ALT ≤2.5 × ULN (≤5 x ULN with liver metastasis)
Cardiac function
LVEF ≥50% at baseline (by echocardiogram or MUGA scan)
Adequate bone marrow function: absolute neutrophil count (ANC) ≥2 × 10⁹/L, platelet count ≥100 × 10⁹/L, and haemoglobin ≥9 g/dL. Adequate liver function: total bilirubin level ≤1.5 × ULN (≤3 x ULN for patients with liver metastases or Gilbert syndrome), AST and ALT ≤2.5 × ULN (≤5 x ULN with liver metastasis). Adequate renal function: estimated creatinine clearance ≥50 mL/min (Cockcroft-Gault or CKD-EPI), urine protein < 2+ or 24h urine protein < 1.0 g. Adequate cardiac function: LVEF ≥50% at baseline (by echocardiogram or MUGA scan).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06529718 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior matched targeted therapy, second-line treatment disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages