Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTongji Hospital

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

440 Participants
are divided into 2 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