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Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

RECRUITINGPhase 2Sponsored by Tianjin Medical University Cancer Institute and Hospital
Actively Recruiting
PhasePhase 2
SponsorTianjin Medical University Cancer Institute and Hospital
Started2024-11-19
Est. completion2025-12-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06727617

Summary

A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
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 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 Criteria:

* Patients with unresectable residual tumors.
* Histologically confirmed diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma.
* Patients who have previously received pelvic radiotherapy.
* 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.
* 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.
* Poorly controlled clinical symptoms or conditions related to heart disease.

Conditions2

CancerCervical Cancers

Interventions1

Serplulimab

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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