Chemotherapy plus camrelizumab for fertility preservation (NACI-F) in FIGO stage IB1 cervical cancer: a multicenter, single-arm, phase 2 trial.

backgroundThe increasing prevalence of cervical cancer in younger women highlights the need for personalized fertility-preserving treatment strategies. Current fertility preservation approaches for early-stage cervical cancer primarily involve cervical conization and radical trachelectomy. However, removing part or all of the cervix can negatively impact reproductive outcomes. These procedures increase the risk of preterm birth and miscarriage, and sometimes require additional surgery due to positive margins. Combined chemotherapy and immune checkpoint inhibitor (ICI) therapy has demonstrated promising efficacy and tolerability in treating locally advanced cervical cancer. However, its role as a non-surgical, fertility-sparing treatment for stage IB1 disease remains unclear.

methodsThis multicenter, single-arm, phase II trial is designed to evaluate the efficacy and safety of combining chemotherapy with camrelizumab as a fertility-preserving strategy for patients with International Federation of Gynecology and Obstetrics 2018 stage IB1 cervical cancer. Key inclusion criteria include: 1) pathologically confirmed cervical squamous cell carcinoma, 2) transformation zone of TZ1 or TZ2, 3) programmed death-ligand 1 combined positive score ≥1, and 4) age 18-45 with a desire to preserve fertility. Key exclusion criteria include being unable to achieve pregnancy even with assisted reproductive technology; autoimmune disease requiring systemic therapy; and prior exposure to ICIs or contraindications to study drugs. A total of 40 patients will be recruited from multiple centers across China. Enrolled patients will receive 1 cycle of chemotherapy (nab-paclitaxel + cisplatin), 2 cycles of chemotherapy combined with camrelizumab, and 3 cycles of camrelizumab alone. Those who achieve tumors ≤2 cm, no new lesions, and a biopsy-proven pathological response will undergo cervical conization combined with pelvic lymphadenectomy or pelvic lymphadenectomy alone. The primary endpoint is the pathological complete response rate. Secondary endpoints include the negative human papillomavirus conversion rate, pregnancy rate, miscarriage rate, live birth rate, preterm birth rate, adverse events, quality of life, event-free survival, and overall survival.

trial registrationClinicalTrials.gov Identifier: NCT06289062.