ClinicaliQ Trial Snapshot
- Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients — Recruiting • Phase II • Oncology • NCT06529718.
- What is being tested: Ivonescimab (a PD-L1/CTLA-4 bispecific antibody) is being compared against standard FOLFOX chemotherapy in patients with advanced biliary tract cancer who have progressed after initial chemotherapy treatment.
- Patient eligibility overview: The trial enrolls patients with advanced biliary tract cancer who have experienced treatment failure with first-line chemotherapy and meet standard performance and organ function criteria for receiving systemic cancer therapy.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : 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. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (≤3 x ULN for patients with liver metastases or confirmed/suspected Gilbert syndrome, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 x ULN when documented liver metastasis). 12. Adequate renal function: estimated creatinine clearance ≥50 mL/min according…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.