Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06419673
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
  • Cisplatin — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion
  • Brachytherapy and External Beam Radiotherapy — RADIATION
    Brachytherapy and External Beam Radiotherapy

Study Details

This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Key Dates

Start date
May 1, 2024
Status verified
May 2024
Primary completion
May 31, 2025
Completion
May 31, 2028

Study Design

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

Arms

  • Experimental: Serplulimab + chemoradiotherapy , Serplulimab maintenance
    Participants receive serplulimab 300 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 3 cycles followed by serplulimab 300 mg IV on Day 1 of each 6-week cycle (Q3W) for an additional 15 cycles. During the Q3W dosing period of serplulimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks.
  • Active Comparator: Concurrent chemoradiotherapy
    Participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks.

Primary Outcome Measure

Progression-Free Survival(PFS) at Month 36 [ Time Frame: Up to approximately 46 months. ]

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