RecruitingPhase 2NCT07340489

Serplulimab for Locally Advanced Cervical Cancer

Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

216 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. The primary endpoint of this study is progression-free survival (PFS).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called serplulimab to standard chemoradiation (combined chemotherapy and radiation therapy) improves outcomes for women with locally advanced cervical cancer that cannot be surgically removed. **You may be eligible if...** - You are a woman aged 18–75 - You have locally advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) confirmed by biopsy, at stage IB2–IVA - You have not received any prior cancer treatment - You are otherwise in good health (ECOG 0–1) with adequate blood and organ function - You have a life expectancy over 6 months **You may NOT be eligible if...** - Your cancer is small cell type, has recurred, or has spread to distant organs - You have received any prior cancer treatment - You have another active cancer (with some exceptions) - You are pregnant or breastfeeding 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)

RADIATIONradiotherapy

Pelvic external beam radiotherapy was delivered with a prescribed dose of 45.0-50.4 Gy in 25-28 fractions to the PTV, administered once daily, five days per week; the PGTVnd received a simultaneous integrated boost to 53.50-59.92 Gy in 25-28 fractions. During radiotherapy, concurrent chemotherapy with weekly cisplatin was administered. Brachytherapy was delivered with 28 Gy in 4 fractions, prescribed to the 100% isodose line covering the CTV.

DRUGChemotherapy

Two cycles of induction chemotherapy were administered prior to concurrent chemoradiotherapy, consisting of cisplatin 60-75 mg/m² on days 1 and 2 of each cycle, once every 3 weeks (21 days), and nab-paclitaxel 135-175 mg/m² by intravenous infusion on day 1 of each cycle, once every 3 weeks (21 days). After completion of concurrent chemoradiotherapy, patients received four cycles of consolidation chemotherapy using the same cisplatin and nab-paclitaxel regimen as above.


Locations(1)

Tianjin Medical University Cancer Institute & Hospital,

Tianjin, Tianjin Municipality, China

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NCT07340489


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