560P Neoadjuvant camrelizumab plus chemotherapy in patients with locally advanced cervical cancer (NACI): A prospective, single-arm, phase II trial

Neoadjuvant chemotherapy (NACT) is an emerging approach for locally advanced cervical cancer (LACC), while two-thirds of patients (pts) respond to it and pts without response benefit little. PD-1 inhibitors have exhibited promising role in recurrent or metastatic cervical cancer. Additionally, preclinical evidence for the activation and synergistic effects of NACT on PD-1 inhibitors supports the superiority of neoadjuvant immunotherapy. We designed this phase II study to evaluated the efficacy and safety of preoperative PD-1 inhibitor camrelizumab combined chemotherapy in pts with LACC. Pts were eligible for enrollment if they had previously untreated LACC (2018 FIGO staged IB3, IIA2 and IIB/IIIC1r (tumor size> 4cm). Eligible pts received neoadjuvant immunotherapy consisting of cycle 1 nab-paclitaxel (260mg/m2, q3w) with cisplatin (75-80 mg/m2, q3w), and subsequent 2 cycles combination chemotherapy (as in cycle 1) plus camrelizumab (200mg, q3w). Either surgery or concurrent chemoradiotherapy was conducted according to the response. The primary endpoint was objective response rate (ORR), and the secondary endpoints were pathological complete remission (pCR) rate, rate of postoperative adjuvant treatment, disease-free survival, overall survival and safety. From Dec 1, 2020 to Jul 20, 2022, 59 pts were enrolled, and 48 pts were evaluated for response, of which four (8.33%) pts achieved a complete response (CR), and 44 (91.67%) had a partial response (PR). The ORR was 100% and all pts completed surgery, with a pCR rate 29.17% (14/48). Regarding the pathological findings of surgical specimens, 11 (22.92%) pts needed postoperative adjuvant treatment as indicated in NCCN guideline, of which six had lymph node metastasis, two had parametrial invasion and the other three met Sedlis criteria. The most common grade 3 or 4 adverse events were lymphocytopia and leukopenia. NACT plus camrelizumab for LACC demonstrated extremely high ORR and pCR rate with manageable toxicity profile, and greatly reduced the need of postoperative adjuvant therapy. The encouraging results promoted us to continue this phase II study.