NCT07340489

Serplulimab for Locally Advanced Cervical Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a randomized, controlled, open-label, phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy and concurrent chemoradiotherapy in patients with locally advanced cervical cancer. Eligible patients are women aged 18-75 years with FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB disease with lymph node positivity or stage III-IVA disease. Patients will be randomly assigned to two groups. Patients in the control group will receive serplulimab immunotherapy combined with concurrent chemoradiotherapy, followed by maintenance serplulimab for up to 2 years. Patients in the experimental group will receive, in addition to the above treatment, two cycles of induction chemotherapy and four cycles of consolidation chemotherapy, consisting of paclitaxel and platinum-based agents. The primary endpoint of this study is progression-free survival (PFS), which will be assessed by investigators according to RECIST version 1.1.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
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)
RADIATION	radiotherapy	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.
DRUG	Chemotherapy	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.

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: China