Actively Recruiting
Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-01-06
134
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
CONDITIONS
Official Title
Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 65 years at the time of signing informed consent
- ECOG performance status score of 0 or 1
- Positive PD-L1 status (CPS �3D 1)
- Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- FIGO stage IB1, IB2, IIA1, or IIA2
- Underwent radical hysterectomy and pelvic lymphadenectomy of type II or III
- Postoperative pathology confirms at least two of these risk factors: lymph node metastasis, positive parametrial or resection margins, lymphovascular space invasion, deep stromal invasion
- Absolute neutrophil count at least 1.5 �D7 10�B9/L
- Platelet count at least 100 �D7 10�B9/L
- Total bilirubin, ALT, and AST levels no more than 1.5 times the upper limit of normal
- Creatinine levels not exceeding upper limit of normal
- Negative serum pregnancy test within 14 days prior to treatment
- Agree to use effective contraception during treatment and for 6 months after
- Not breastfeeding during treatment
- Willing and able to comply with trial and follow-up procedures
You will not qualify if you...
- Unresectable residual tumors
- Diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma
- Previous pelvic radiotherapy
- History of other untreated malignant tumors within past 5 years except cured basal cell carcinoma or carcinoma in situ
- Any active or known autoimmune disease
- History or current inflammatory/autoimmune diseases requiring steroid treatment
- Use of systemic corticosteroids or immunosuppressive agents within 14 days prior to randomization
- History of thromboembolic events within 6 months prior to enrollment
- Poorly controlled heart disease or related symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here