Serplulimab for Locally Advanced Cervical Cancer

Korábbi kezelés

• Prior anti-tumor treatment;
• Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization;
• Arterial or venous thromboembolic events within 6 months prior to enrollment;
• Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies;

Más betegség

• Histologically confirmed small cell cervical cancer;
• Recurrent cervical cancer or presence of distant metastases;
• Current or history of another active, untreated malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ;
• Any active or known autoimmune disease;
• Active infection;
• Uncontrolled clinically significant cardiac symptoms or disease;
• Neurological or psychiatric abnormalities affecting cognitive function;
• Any other condition or situation that, in the investigator's judgment, would pose a serious risk to the subject's safety, potentially confound study results, or interfere with the subject's ability to complete the study.

Egyéb

• Pregnant or breastfeeding women;

• Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF);
• Willing and able to comply with all study procedures;
• Female aged 18-75 years;
• ECOG performance status of 0 or 1;
• PD-L1 status not restricted;
• Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
• FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA;
• Patients must meet the following hematologic, renal, and hepatic function criteria:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); Serum creatinine ≤ upper limit of normal (ULN); No prior anti-tumor treatment; Expected survival \> 6 months;
• Female subjects must have a negative serum pregnancy test within 14 days prior to study treatment, agree to use effective contraception during treatment and for 6 months after treatment, and breastfeeding is prohibited during the study.