Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
NCT06419673 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2024-05-17
Summary
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.
Conditions
Interventions
- DRUG
-
Serplulimab
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.
- DRUG
-
IV infusion
- DRUG
-
IV infusion
- RADIATION
-
Brachytherapy and External Beam Radiotherapy
Brachytherapy and External Beam Radiotherapy
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
LINGYING WU, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2025-05-31
- Completion
- 2028-05-31
Countries
- China
Study Locations
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