Serplulimab for Locally Advanced Cervical Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07340489
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    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)
  • radiotherapy — RADIATION
    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.
  • Chemotherapy — DRUG
    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.

Study Details

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).

Key Dates

Start date
Dec 3, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: chemotherapy combined with immunotherapy and radiotherapy
    chemotherapy an Serplulimab plus chemoradiotherapy group
  • Placebo Comparator: Control group: immunotherapy and radiotherapy
    Serplulimab plus chemoradiotherapy group

Primary Outcome Measure

PFS [ Time Frame: through study completion, an average of 2 year ]

Central Contacts

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