Phase II Study of Neoadjuvant Immunochemotherapy Using Paclitaxel, Carboplatin, and PD-1PD-L1 Inhibitors for Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining paclitaxel and carboplatin chemotherapy with PD-1PD-L1 immune checkpoint inhibitors for treating locally advanced cervical cancer. This Phase II, single-arm study focuses on patients with cervical cancer stages IB3 to IIB and aims to better understand treatment responses at the molecular level using single-cell RNA sequencing. The study is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. All participants will receive three cycles of neoadjuvant immunochemotherapy with paclitaxel, carboplatin, and a PD-1PD-L1 inhibitor. After chemotherapy, patients will undergo open radical hysterectomy and pelvic lymphadenectomy surgery. Postoperative adjuvant therapy, including chemotherapy, chemoradiation, or maintenance immunotherapy, will be decided based on pathological results. Tumor tissue samples will be collected during treatment for detailed molecular analysis. Participants will be closely monitored through tumor assessments to measure the objective response rate three months after treatment. Secondary outcomes include overall survival, progression-free survival up to three years, and treatment-related side effects. The study plans to enroll at least 34 patients who meet the eligibility criteria. Tissue samples from high and low treatment responders will undergo molecular sequencing to investigate the tumor microenvironment and gene expression changes, helping to optimize personalized therapies.

Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial