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RECRUITING
NCT06727617
PHASE2

Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China