Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Single-center, Phase II Clinical Study
This study aims to evaluate the efficacy and safety of Tislelizumab combined with concurrent chemoradiotherapy in the treatment of cervical cancer patients with cervical mass \> 4cm and regional lymph node metastasis, paracervical invasion and regional lymph node metastasis, stage IIIA, stage IIIB, and stage IVA. To provide a clinical reference for finding a safe and effective individualized treatment plan to improve the survival prognosis of locally advanced cervical cancer patients.
• Aged 18 to 70 years.
• The pathological types of cervical cancer confirmed by histopathology were squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma.
• In FIGO stage 2018, cervical mass \> 4cm with regional lymph node metastasis, paracervical invasion with regional lymph node metastasis, stage IIIA, stage IIIB, and stage IVA.
• Having at least one measurable lesion according to RECIST 1.1.
• ECOG score 0-1.
• Expected survival time ≥6 months.
• Major organ function is normal, that is, meeting the following criteria: blood routine: HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L; Biochemical examination of ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml/min.
• Menopausal women, or women of childbearing age who meet all the following conditions: non-lactation, not pregnant, and can take adequate contraceptive measures during the study treatment.
• Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.