Actively Recruiting
Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
Led by UNICANCER · Updated on 2025-11-17
72
Participants Needed
3
Research Sites
172 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
C
Cancer Research UK & UCL Cancer Trials Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form before any trial procedures
- Diagnosed with intrahepatic cholangiocarcinoma, perihilar/distal cholangiocarcinoma, or gallbladder carcinoma
- Have locally advanced (non-resectable) or metastatic disease
- Participated in the screening phase of the SAFIR-ABC10 trial
- Experienced disease progression after first-line standard chemotherapy (CISGEM ± immunotherapy)
- Eligible for second-line treatment with FOLFOX
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have at least one measurable lesion by RECIST v1.1
- Aged 18 years or older
- Adequate bone marrow function with specific blood count levels
- Adequate liver function within defined laboratory limits
- Adequate kidney function with creatinine clearance or glomerular filtration rate ≥ 50 mL/min and low urine protein
- Coagulation parameters within specified limits
- Adequate cardiac function with left ventricular ejection fraction ≥ 50%
- Documented hepatitis B or C status and management
- Esophagogastroduodenoscopy performed within 6 months and treated varices if present
- Biliary tract obstruction relieved and adequate biliary drainage without infection
- Women of childbearing potential and unsterilized males agree to effective contraception
- Negative pregnancy tests for women of childbearing potential before starting treatment
- Willing and able to comply with study protocol and visits
- Affiliated with a social security system or equivalent private health insurance
You will not qualify if you...
- Unresolved toxicities from first-line treatment greater than grade 1 except alopecia
- Received first-line maintenance therapy with matched target therapy or any second-line treatment
- Contraindications to ivonescimab
- Complete deficiency of dihydropyrimidine dehydrogenase (DPD)
- Treatment with brivudine, sorivudine, or analogues within 4 weeks prior to randomization
- Major surgery or serious trauma within 4 weeks before randomization or planned within 4 weeks after first dose
- History of bleeding disorders or clinically significant recent bleeding within 4 weeks
- Current high blood pressure uncontrolled by medication
- History of serious heart disease or vascular conditions within past 12 months
- Recent severe gastrointestinal conditions or bleeding within 6 months
- Recent severe thromboembolic or cerebrovascular events within 6 months
- Acute worsening of chronic obstructive pulmonary disease within 4 weeks
- History of gastrointestinal perforation, obstruction, or extensive bowel resection within 6 months
- Imaging showing major blood vessel invasion or intra-tumor cavitation
- Microsatellite instability positive disease
- Concurrent malignancy except some treated skin or cervical cancers
- HIV positive or active tuberculosis
- Immunosuppressive therapy within 14 days before study therapy
- Active autoimmune disease requiring systemic treatment in past 2 years with some exceptions
- Prior bone marrow or solid organ transplantation
- Any condition making participation undesirable or unsafe per investigator
- Pregnant or breastfeeding females
- Participation in another therapeutic trial within 30 days before study entry
- Unable or unwilling to comply with medical follow-up requirements
- Individuals deprived of liberty or under protective custody or guardianship
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Trial Site Locations
Total: 3 locations
1
Institute Mutualiste Montsouris
Paris, France
Not Yet Recruiting
2
Centre Eugène Marquis
Rennes, France
Actively Recruiting
3
University College London
London, United Kingdom
Not Yet Recruiting
Research Team
D
Daniel Couch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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