Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

Prior treatment

• 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.

Other illness

• 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.

Other

• Patients with unresectable residual tumors.
• Histologically confirmed diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma.

• 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.