Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTongji Hospital

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

40 Participants
are divided into 1 treatment group

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