Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06727617
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cervical Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 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)
  • Chemotherapy — DRUG
    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.
  • radiotherapy — RADIATION
    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.

Study Details

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

Key Dates

Start date
Nov 19, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Serplulimab plus chemoradiotherapy group
    Serplulimab plus chemoradiotherapy group
  • Placebo Comparator: chemoradiotherapy group
    chemoradiotherapy group

Primary Outcome Measure

DFS [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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