Ivonescimab in Combination With Liposomal Irinotecan and 5-FU/LV in Potentially Resectable Biliary Tract Malignancies
A Phase II, Open-Label, Single-Arm, Single-Center Study of Ivonescimab in Combination With Liposomal Irinotecan and 5-Fluorouracil/Leucovorin in Patients With Potentially Resectable Biliary Tract Malignancies
Sponsor: Tianjin Medical University Cancer Institute and Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
surgical conversion success rate
Time frame: From the start of conversion therapy until surgical evaluation or resection, or until it is determined that surgical resection is not feasible.
Eligibility Criteria
Inclusion Criteria: * Patients eligible for inclusion in this study must meet all of the following criteria: 1. Informed Consent: Able to provide written informed consent and understand and agree to comply with study requirements and the assessment schedule. 2. Age and Gender: Age ≥18 years and ≤75 years on the day of signing the Informed Consent Form (ICF), male or female. 3. Disease Status: Potentially resectable, previously untreated biliary tract malignancy confirmed by histological or cytological evidence. 4. Tumor Assessment: Tumor evaluated by a hepatobiliary surgeon with sufficient objective evidence to determine irresectability. 5. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. Life Expectancy: Estimated survival of more than 12 weeks. 7. Body Weight: Weight \>30 kg. 8. Prior Therapy: No prior anti-tumor therapy, including but not limited to anti-CTLA-4, anti-VEGF, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies. …
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Expert commentary on why this trial matters and what to watch for.
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