Actively Recruiting
Serplulimab Plus Chemoradiotherapy vs Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer Patients With Multiple Risk Factors: A Randomized, Open-Label, Phase II Clinical Trial
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-01-06
134
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Serplulimab combined with chemoradiotherapy as an additional treatment for patients who have undergone surgery for cervical cancer and have multiple risk factors such as lymph node metastasis, positive surgical margins, lymphovascular space invasion, or deep stromal invasion. This Phase II, randomized, controlled, and open-label trial aims to compare the effectiveness and safety of Serplulimab plus chemoradiotherapy against chemoradiotherapy alone in this patient group. Patients must be suitable for chemotherapy with cisplatin or carboplatin plus nab-paclitaxel as determined by the study doctor. Participants will be randomly assigned in equal numbers to one of two groups: one receiving Serplulimab via intravenous infusion at 300 mg every 3 weeks for up to 2 years alongside chemoradiotherapy, and the other receiving chemoradiotherapy alone. Chemotherapy includes cisplatin given weekly during concurrent chemoradiotherapy or in cycles during sequential chemoradiotherapy, plus nab-paclitaxel administered every 3 weeks for several cycles. Radiotherapy involves pelvic external beam radiation delivered five times per week with a total dose between 45 and 50 Gy. Throughout the study, participants will be closely monitored with assessments including disease-free survival measured over about one year. Additional outcomes such as overall survival and recurrence-free survival will also be evaluated. The trial involves regular visits for treatment administration and follow-up to track safety and treatment effects. The total participation duration and visits will be guided by the treatment schedule and monitoring needs.
CONDITIONS
Brief 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 consent
- Voluntarily agree to participate and sign informed consent
- ECOG performance status score of 0 or 1
- Positive PD-L1 status (CPS ≥1)
- Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- FIGO stage IB1, IB2, IIA1, or IIA2
- Underwent radical hysterectomy (Piver classification) and pelvic lymphadenectomy type II or III
- Postoperative pathology shows at least two risk factors: lymph node metastasis, positive parametrial or resection margins, lymphovascular space invasion, or deep stromal invasion
- Meet blood, kidney, and liver function criteria: neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, bilirubin, ALT, and AST ≤1.5 times normal, creatinine normal
- Negative serum pregnancy test within 14 days before treatment and agree to use contraception during treatment and for 6 months after
- Not breastfeeding and able to comply with trial and follow-up procedures
You will not qualify if you...
- Presence of unresectable residual tumors
- Diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma
- Previous pelvic radiotherapy
- Other untreated cancers within 5 years except cured basal cell carcinoma or carcinoma in situ
- Active or known autoimmune diseases
- History or current inflammatory/autoimmune diseases requiring steroid treatment
- Use of corticosteroids or immunosuppressants within 14 days before randomization
- Thromboembolic events within 6 months prior to enrollment
- Poorly controlled heart-related symptoms or conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 2 years (up to 35 treatment cycles of serplulimab; chemoradiotherapy duration as per schedule)
Participants receive serplulimab combined with chemoradiotherapy or chemoradiotherapy alone as adjuvant treatment after surgery for cervical cancer.
Weekly visits for chemoradiotherapy during radiation; serplulimab administered every 3 weeks; chemotherapy cycles every 3 weeks or weekly depending on regimen
Duration - Up to 1 year after treatment completion
Participants are monitored for disease-free survival and overall survival after completing treatment.
Periodic visits for follow-up assessments
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.
Y
Ying Chen, Dr.
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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