RecruitingPhase 2NCT06727617

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

134 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called serplulimab to standard radiation and chemotherapy (chemoradiotherapy) improves outcomes in women with early-stage cervical cancer who have risk factors for recurrence after surgery. **You may be eligible if...** - You are a woman aged 18 to 65 - You have confirmed cervical cancer (squamous cell, adenocarcinoma, or adenosquamous) - Your cancer is early-to-intermediate stage (FIGO IB1, IB2, IIA1, or IIA2) - You had a full radical hysterectomy and pelvic lymph node removal - After surgery, pathology showed at least 2 high-risk features (e.g., lymph node spread, positive margins, deep invasion, or lymphovascular invasion) - Your tumor tested positive for PD-L1 (a marker that predicts immunotherapy response) - You are in good general health and your blood counts and organ function are normal **You may NOT be eligible if...** - You have remaining tumor that could not be removed - You have rare cervical cancer types (small cell neuroendocrine or mucinous adenocarcinoma) - You had prior pelvic radiation - You have an active autoimmune disease or are on steroids/immunosuppressants - You had a blood clot event in the past 6 months - You have serious heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

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)

DRUGChemotherapy

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.

RADIATIONradiotherapy

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

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NCT06727617


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