Tests serplulimab with chemoradiotherapy after surgery for cervical cancer
Tests serplulimab added to chemoradiotherapy in adults with cervical cancer after surgery.
Plain-language title generated from the registry record
Registry title: Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer who have had a radical hysterectomy and have at least two risk factors found after surgery. It tests serplulimab added to chemoradiotherapy.
- Age
- 18 to 65 years
- Sex
- Women. The record lists sex as ALL but the inclusion criteria say female.
- Disease stage
- Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. FIGO stage IB1, IB2, IIA1, or IIA2. After surgery, at least two risk factors: lymph node spread, positive parametrium or surgical margins, lymphovascular space invasion, or deep stromal invasion.
- Earlier treatment
- Must have had a radical hysterectomy with pelvic lymph node removal (type II or III). Cannot have had pelvic radiotherapy before.
- Biomarker or test result
- PD-L1 positive (CPS ≥1).
Main reasons for not taking part
- Tumor left behind that cannot be removed
- Small cell (neuroendocrine) or mucinous cervical cancer
- Active or known autoimmune disease
- Treatment with steroids or other immune-suppressing drugs within 14 days before randomization
- Blood clot (venous or arterial) within 6 months before joining
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06727617, who can take part
Where in China
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University Cancer Institute and Hospital
- Trial code
- NCT06727617
- Record updated
- 6 January 2026
- Original description
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk FactorsRead full original descriptionShow less
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
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
Inclusion: Voluntarily participate in the clinical study: Fully understand and be informed about the study, and sign the informed consent form (ICF); willing to comply with and capable of completing all trial procedures; Female aged ≥18 years and ≤65 years at the time of signing the ICF; ECOG PS score of 0 or 1; Positive PD-L1 status (CPS ≥1); Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; FIGO (International Federation of Gynecology and Obstetrics) stage of IB1, IB2, IIA1, or IIA2, and patients judged by the investigator to benefit from radical surgery and/or adjuvant therapy; Have undergone radical hysterectomy (Piver classification) and pelvic lymphadenectomy of type II or III; Postoperative pathological examination confirms at least two adverse factors, which may include: Lymph node metastasis; Positive parametrial or positive resection margins; Lymphovascular space invasion; Deep stromal invasion; Patients must meet the following hematological, renal, and liver function criteria: Absolute neutrophil count of at least 1.5 × 10⁹/L; Platelet count of at least 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal; Creatinine levels not exceeding the upper limit of normal; Female participants must have a negative serum pregnancy test within 14 days prior to treatment and agree to use effective contraception during the treatment period and for 6 months afterward; breastfeeding is prohibited during treatment; Willing and able to comply with the trial and follow-up procedures.
Exclusion: Patients who have previously received pelvic radiotherapy; Diseases requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization; History of thromboembolic events (venous or arterial) occurring within 6 months prior to enrollment; History of other untreated malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ; Presence of any active or known autoimmune disease; History of inflammatory/autoimmune diseases requiring steroid treatment, or currently suffering from inflammatory/autoimmune diseases that require steroid treatment; Poorly controlled clinical symptoms or conditions related to heart disease; Patients with unresectable residual tumors; Histologically confirmed diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma.