Phase II Study of Serplulimab Combined With Chemoradiotherapy as Additional Treatment After Surgery for Cervical Cancer Patients With Multiple Risk Factors

What this Trial Is About

Researchers are evaluating the use of Serplulimab combined with chemoradiotherapy as an additional treatment for patients who have undergone surgery for cervical cancer and have multiple risk factors such as lymph node metastasis, positive surgical margins, lymphovascular space invasion, or deep stromal invasion. This Phase II, randomized, controlled, and open-label trial aims to compare the effectiveness and safety of Serplulimab plus chemoradiotherapy against chemoradiotherapy alone in this patient group. Patients must be suitable for chemotherapy with cisplatin or carboplatin plus nab-paclitaxel as determined by the study doctor. Participants will be randomly assigned in equal numbers to one of two groups one receiving Serplulimab via intravenous infusion at 300 mg every 3 weeks for up to 2 years alongside chemoradiotherapy, and the other receiving chemoradiotherapy alone. Chemotherapy includes cisplatin given weekly during concurrent chemoradiotherapy or in cycles during sequential chemoradiotherapy, plus nab-paclitaxel administered every 3 weeks for several cycles. Radiotherapy involves pelvic external beam radiation delivered five times per week with a total dose between 45 and 50 Gy. Throughout the study, participants will be closely monitored with assessments including disease-free survival measured over about one year. Additional outcomes such as overall survival and recurrence-free survival will also be evaluated. The trial involves regular visits for treatment administration and follow-up to track safety and treatment effects. The total participation duration and visits will be guided by the treatment schedule and monitoring needs.

Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors