An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer.
The objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. The primary questions it aims to address are: Can the Enlonstobart combination regimen improve the objective response rate and disease control rate in patients with locally advanced cervical cancer? What is the safety and tolerability profile of this combination regimen, and will any unexpected serious adverse events occur? Participants will: Receive induction therapy with Enlonstobart in combination with chemotherapy agents (e.g., paclitaxel plus platinum); Receive Enlonstobart in combination with concurrent chemoradiotherapy (external beam radiation therapy plus brachytherapy, with concurrent chemotherapy); Undergo regular tumor imaging evaluations (CT/MRI) and hematological safety assessments; Cooperate in completing efficacy assessments, adverse event documentation, and long-term follow-up.
• Ages 18-75;
• Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma confirmed by histology or cytopathology;
• Patients with locally advanced cervical cancer who have not previously received any treatment and are classified as FIGO stage III-IV A as of 2018;
• ECOG performance status 0-1;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/dL, platelets (PLT) ≥ 100 × 10⁹/L;
• Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); if liver metastases are present, ≤ 5×ULN; total bilirubin ≤ 1.5×ULN (this limit may be relaxed to 3×ULN for subjects with Gilbert's syndrome);
• Renal function: Serum creatinine (Cr) ≤ 1.5×ULN; if \> 1.5×ULN, creatinine clearance must be ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);
• Coagulation: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN;
• According to the RECIST 1.1 criteria, the patient must have at least one evaluable lesion;
• Patients of childbearing potential must have a negative pregnancy test result and voluntarily use effective and reliable contraception during the study;
• Voluntarily participate in the study and sign an informed consent form.