NCT06727617 Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
| NCT ID | NCT06727617 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Cervical Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief Summary
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
Eligibility Criteria
Inclusion Criteria: * 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 mu
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