Study of Camrelizumab with Etoposide and Cisplatin as Pre-Surgery Treatment for Neuroendocrine Cervix Carcinoma in Women

What this Trial Is About

Researchers are evaluating the effectiveness and safety of karelizumab combined with etoposide and cisplatin as a neoadjuvant treatment for neuroendocrine cervix carcinoma. This is an exploratory, single-arm Phase 2 clinical study focusing on patients with stage I-II cervical neuroendocrine carcinoma. The study aims to see how well this combination works before surgery and further treatment. Participants will receive treatment cycles where karelizumab is given first, followed by cisplatin and then etoposide, with at least 30 minutes between each drug. Patients who show complete or partial response will proceed to radical surgery and receive additional therapy afterward. Those with stable or progressive disease, or who are not suitable for surgery, will be treated with concurrent chemoradiotherapy. Throughout the study, participants will be monitored for tumor response using imaging to measure target lesions. The primary outcome is the objective response rate at 6 months. Secondary outcomes include progression-free survival, disease-free survival, overall survival rates at 1 and 3 years, disease control rates, and the incidence of adverse events over 5 years. Participants will undergo regular assessments of organ function, blood tests, and clinical evaluations to track safety and effectiveness during and after treatment.

Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin