Ivonescimab (PD-1/VEGF Bispecific Antibody) Plus Radiofrequency Ablation for Multiple Advanced Tumors After PD-1 Therapy Failure
Ivonescimab (PD-1/VEGF Bispecific Antibody) Plus Radiofrequency Ablation for Multiple Advanced Tumors After PD-1 Therapy Failure: A Multicohort, Multicenter, Single-Arm Phase II Study
Sponsor: Sheng Zhang
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria.
Time frame: Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years).
Secondary Endpoints
Time from treatment start to progression by RECIST V.1.1.
Time from treatment start to death of participants.
Type, incidence, severity, onset and end time of adverse events (AE) evaluated according by the version 5.0 of NCI-CTCAE.
Eligibility Criteria
Inclusion Criteria: * Voluntarily provide written informed consent * Age ≥18 years old * Histologically and/or cytologically confirmed advanced tumors as assessed by imaging or ultrasound * ECOG score: 0-2 * At least one measurable lesion (according to RECIST criteria, the major diameter of non-lymph node lesions on CT scan ≥10 mm, and the minor diameter of lymph node lesions on CT scan ≥15 mm); There are other lesions that can be treated with radiofrequency * Blood routine: Absolute Neutrophil Count (ANC) 1.5×10\^9/L, Platelet (PLT) ≥70×10\^9/L, Hemoglobin (HGB) ≥80g/L * Liver function: serum Total Bilirubin (TBIL) ≤1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN, and AST and ALT ≤5.0 ULN in patients with liver metastasis; Serum albumin ≥28 g/L * Renal function: serum Creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/mi (using the standard Cockcroft-Gault formula) 9. Coagulation: International Normalized Ratio (INR)…
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