NCT06727617

Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

Serplulimab Plus Chemoradiotherapy vs Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer Patients With Multiple Risk Factors: A Randomized, Open-Label, Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors

Detailed description

This study is a randomized, controlled, open-label, Phase II clinical trial designed to enroll patients with at least two risk factors (risk factors: lymph node metastasis, positive parametrial or resection margins, lymphovascular space invasion, or deep stromal invasion) following radical surgery for cervical cancer. The study aims to evaluate the efficacy and safety of Serplulimab in combination with chemoradiotherapy compared to chemoradiotherapy alone as adjuvant treatment. Patients must be deemed suitable for cisplatin or carboplatin plus nab-paclitaxel treatment as determined by the investigator. The choice between carboplatin and cisplatin will be based on the clinical judgment of the investigator. Eligible patients will be randomized in a 1:1 ratio to one of the following treatment arms: patients receiving Serplulimab plus chemoradiotherapy as adjuvant treatment (experimental group) or patients receiving chemoradiotherapy alone as adjuvant treatment (control group). The study is expected to enroll 67 patients in each group.

Conditions

• Cervical Cancers

Interventions

Type	Name	Description
DRUG	Serplulimab	intravenous infusion of 300 mg, administered every 3 weeks as one cycle, on the first day of each cycle, with a maximum treatment duration of 2 years (up to 35 treatment cycles)
DRUG	Chemotherapy	Cisplatin: Administered by intravenous infusion during concurrent chemoradiotherapy at a dose of 30-40 mg/m² once weekly for only 5-6 treatment cycles; during sequential chemoradiotherapy, administered at 60-75 mg/m² on the first and second days of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles. Paclitaxel: Nab-paclitaxel administered by intravenous infusion at a dose of 135-175 mg/m² on the first day of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles.
RADIATION	radiotherapy	Pelvic external beam radiation therapy at a dose of 1.8 Gy per fraction or 2 Gy per day, 5 times per week, with a total dose of 45-50 Gy.

Timeline

• Start date: 2024-11-19
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-12-11
• Last updated: 2026-01-06

Locations

1 site across 1 country: China