A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
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)
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.
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.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDFS
The time from the date of random assignment to the first occurrence of locoregional failure, DM, second primary tumor, or death from any cause.
Time frame: through study completion, an average of 1 year
OS
The time from random assignment to death because of any cause.
Time frame: through study completion, an average of 1 year
RFS
The time from random assignment to death because of any recurrence.
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.