Open-label, prospective phase 2 study to evaluate the efficacy and safety of camrelizumab combined with etoposide and cisplatin as neoadjuvant therapy in patients with neuroendocrine carcinoma of the cervix.

TPS5624 Background: Camrelizumab, a humanized monoclonal antibody, specifically targets PD-1 to inhibit its interaction with PD-L1, thereby reactivating the T cell immune response against tumors. The NACI study demonstrated that, in the treatment of locally advanced cervical cancer, the combination of camrelizumab and neoadjuvant chemotherapy achieved an overall response rate (ORR) of 100%. Specifically, complete remission was observed in 4 patients (8.33%), while 44 patients (91.67%) experienced partial remission. This regimen significantly outperformed traditional treatments in efficacy, with manageable toxicity levels. Neuroendocrine carcinoma of the cervix (NECC) is a highly rare and aggressive malignancy characterized by its distinctive biological behavior, propensity for early lymph node and hematogenous metastasis, and limited effective treatment options, leading to a dismal prognosis. Although PD-1 inhibitors have shown promise in some NECC case reports, there is a notable absence of comprehensive, prospective clinical trials to substantiate their effectiveness. This study aims to assess the efficacy and safety of neoadjuvant chemo-immunotherapy in patients with NECC. Methods: This open-label, single-arm, prospective phase II study evaluates the antitumor efficacy and safety of camrelizumab in combination with etoposide and cisplatin in roughly 30 patients with NECC. Eligible participants are aged 18-75, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1, and histologically confirmed NECC, specifically targeting small cell and large cell neuroendocrine cervical carcinoma but excluding atypical and typical carcinoid tumors. Inclusion criteria stipulate that if NECC is present alongside other tumor types, the neuroendocrine carcinoma component must account for more than 60% of the tumor mass. The treatment protocol involves neoadjuvant chemo-immunotherapy, comprising two to three cycles of camrelizumab (200 mg, IV, day 1), cisplatin (75 mg/m², IV, day 1), and etoposide (100 mg/m², IV, days 1-3) administered every three weeks. Following this, patients achieving complete or partial response will proceed to radical surgery and adjuvant therapy, while those with stable or progressive disease, or considered unsuitable for surgery by gynecological oncologists, will transfer to concurrent chemoradiotherapy. The primary objective is to ascertain the objective response rate as per the Response Evaluation Criteria in Solid Tumors version 1.1. Secondary objectives include disease control rate, progression-free survival, overall survival, and evaluations of safety and tolerability. The study began on December 28, 2023, with ongoing enrollment. Clinical trial information: NCT05910177 .