About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Camrelizumab
- Cisplatin
- Nab paclitaxel
- Radical surgery
- external beam radiation therapy (EBRT) + brachytherapy
- Cisplatin
Treatment groups
Sponsors and collaborators
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