Neoadjuvant Chemotherapy Plus Cadunilizumab Followed by Extrafascial Hysterectomy for FIGO Stage IB2 Cervical Cancer: a Multicenter, Single-arm, Phase 2 Trial.
This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.
• Clinical diagnosis of untreated stage IB cervical cancer with IB2 (FIGO, 2018 criteria; staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);
• At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;
• Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma (any grade), usual type adenocarcinoma (G1 or G2 / Silva A or B), and adenosquamous carcinoma (G1 or G2);
• Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;
• Patient age ≥18 years and ≤70 years;
• ECOG score ≤1;
• Laboratory tests: WBC ≥3. 5×109/L, NEU ≥1. 5×109/L, PLT ≥100×109/L, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and BUN and Cr ≤normal;
• Be willing to follow up and good compliance;
• Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program.