Actively Recruiting
Serplulimab for Locally Advanced Cervical Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-01-14
216
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Serplulimab for Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily willing to participate and signed informed consent
- Willing and able to follow all study procedures
- Female aged 18 to 75 years
- ECOG performance status of 0 or 1
- Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- FIGO 2014 stage IB2-IIB with positive lymph nodes, or stage III-IVA
- Adequate blood, kidney, and liver function as specified
- No prior anti-tumor treatment
- Expected survival greater than 6 months
- Negative pregnancy test within 14 days before treatment
- Agree to use effective contraception during treatment and for 6 months after
- Not breastfeeding during the study
You will not qualify if you...
- Small cell cervical cancer diagnosis
- Recurrent cervical cancer or distant metastases
- Prior anti-tumor treatment
- Current or history of untreated malignancy within past 5 years except certain skin cancers
- Any active or known autoimmune disease
- Active infection
- Need for systemic corticosteroids or immunosuppressants within 14 days before randomization
- Arterial or venous thromboembolic events within past 6 months
- Uncontrolled significant heart symptoms or disease
- Allergy to serplulimab or similar drugs
- Pregnant or breastfeeding
- Neurological or psychiatric conditions affecting cognition
- Any condition judged by investigator to pose safety risks or interfere with study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital,
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
M
Maobin Meng, Dr.
CONTACT
Y
Ying Chen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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