Neoadjuvant Chemotherapy Combined with Camrelizumab for Fertility Preservation in Women Aged 18 to 45 with Stage IB1 Cervical Cancer

What this Trial Is About

Researchers are evaluating a new treatment approach for women with PD-L1 positive stage IB1 cervical cancer who want to preserve their fertility. This phase 2 clinical trial is designed to assess the effects of combining neoadjuvant chemotherapy with the PD-1 inhibitor camrelizumab. The study aims to measure complete pathologic remission, treatment side effects, pregnancy outcomes, and survival rates to better understand this therapys impact on patients wishing to maintain fertility. Participants receive an initial cycle of platinum-based chemotherapy followed by two cycles combining camrelizumab and chemotherapy every three weeks. The study is conducted in two stages in the first stage, patients with tumors 2 cm or smaller and no new lesions undergo cone biopsy and pelvic lymphadenectomy or sentinel lymph node mapping, with follow-up tests to decide further treatment. In the second stage, patients with similar tumor size undergo cervical biopsy and pelvic lymphadenectomy or sentinel lymph node mapping, followed by additional testing based on biopsy results. Treatments are given before surgery to evaluate effectiveness and fertility preservation. Throughout the study, participants are closely monitored with pathology tests, HPV testing, colposcopy, and patient-reported outcome questionnaires. Researchers will track pregnancy rates, miscarriage rates, preterm births, live births, adverse events, and surgical complications over treatment and follow-up periods up to seven years. Event-free and overall survival will also be measured. The total participation may last several years, allowing detailed evaluation of treatment effects and fertility outcomes.

Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer