About this trial
This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, EFS and OS.
Eligibility criteria
Qualifiers
Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and MRI evaluation by the investigator (FIGO 2018);
Pathologically confirmed diagnosis of cervical squamous cell carcinoma;
Transformation zone of TZ1 or TZ2 (IFCPC 2011);
Positive PD-L1 expression by preoperative pathology, i.e., Combined Positive Score (CPS) ≥1;
Disqualifiers
History of infertility, including those with infertility due to tubal or (and) husband;
Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, 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;
History of human immunodeficiency virus (HIV) infection or known active hepatitis B or C;
Trial design
Treatments tested in this trial
- Camrelizumab
- Cisplatin
- Nab paclitaxel
- biopsy
Treatment groups
Sponsors and collaborators
Tongji Hospital
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Third Military Medical University
Collaborator
Beijing Friendship Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Tianjin Medical University
Collaborator
West China Second University Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Gansu Cancer Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator
Anhui Provincial Cancer Hospital
Collaborator