Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2 Trial
Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer. This is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg/kg, iv., D1, q3w）with Cisplatin ( 75mg/ m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.
• Female, age ≥18 years;
• Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, and assessed by the researcher as resectable;
• No previous systemic treatment for the current disease, including surgical treatment, antitumor chemoradiotherapy/immunotherapy, etc.;
• Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no surgical contraindications;
• ECOG score of 0-1;
• Expected survival time \>6 months;
• Sufficient organ function, the subject must meet the following laboratory indicators:
⁃ Neutrophil absolute count (ANC) ≥1.5x10\^9/L ; Platelets ≥100x10\^9/L ;Hemoglobin \>9g/dL ; Total bilirubin ≤1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; Normal thyroid function; Myocardial enzymes within the normal range