It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.
Locally advanced (2018 FIGO staged IB3, IIA2 and IIB（tumor size> 4cm) ) cervical cancer，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, adenocarcinoma (common type), and adenosquamous carcinoma;
Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;
Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;
Has a history of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive, and HCV-RNA above the lower limit of detection of the assay);
Receipt of immunosuppressive medications or systemic corticosteroid therapy for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior to study dosing;
Parallel
Camrelizumab
DrugCamrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
Cisplatin
DrugCisplatin：75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
Nab paclitaxel
DrugNab paclitaxel: 260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
Radical surgery
Procedure/SurgeryRadical surgery
external beam radiation therapy (EBRT) + brachytherapy
RadiationRadiation therapy per standard of care
Cisplatin
DrugChemotherapy administered concurrent with radiation therapy，cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks
Progression-free survival, PFS
PFS is defined as the time from randomisation to tumor progression, postoperative relaspse or metastasis, or death, which occur first.
Objective Response Rate, ORR
The proportion of patients who had either complete response or partial response, assessed by independent central reviewers according to RECIST, version 1.1.
Overall survival, OS
OS is defined as the time from randomisation to death.
Proportion of patients undergoing radical surgery
Proportion of patients undergoing radical surgery for neoadjuvant chemoimmunotherapy plus surgery group
Pathologic Complete Response
Pathologic complete response (pCR) refers to the absence of invasive/in situ cancer in the cervical and/or lymph nodes.
The surgical complication rate
Intraoperative bleeding, vascular injuries, bladder injuries, rectal injuries, and ureteral injuries were measured by the need for suture repair; occlusive nerve injuries were measured by complete severance, and vascular injuries required documentation of the site of injury. Postoperative complications included: cervical stenosis, cervical insufficiency, ureteral/bladder/rectal/vaginal fistula, internal hemorrhage, pelvic infection, lymphocyst, lymphatic fistula, lower extremity edema, lower extremity venous thrombosis, urinary retention, nerve injury, and bowel obstruction.
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Tongji Hospital
Lead sponsor
Southwest Hospital, China
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Qilu Hospital of Shandong University
Collaborator
Beijing Friendship Hospital
Collaborator
Tianjin Medical University General Hospital
Collaborator
West China Second University Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
