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Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2024-11-19
Completion Date
2026-12-31
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
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)
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.
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.
Locations (1)
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China