Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer
This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, EFS and OS.
• Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and MRI evaluation by the investigator (FIGO 2018);
• Pathologically confirmed diagnosis of cervical squamous cell carcinoma;
• Transformation zone of TZ1 or TZ2 (IFCPC 2011);
• Positive PD-L1 expression by preoperative pathology, i.e., Combined Positive Score (CPS) ≥1;
• Patient age ≥18 years and ≤45 years;
• ECOG score ≤1;
• Laboratory tests: white blood cell (WBC) ≥3. 5×109/L, Neutrophil (NEU) ≥1. 5×109/L, platelet (PLT) ≥100×109/L, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and blood urea nitrogen （BUN) and Cr ≤normal;
• Have a strong desire to give birth;
• Willing to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and program.