About this trial
This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.
Eligibility criteria
Qualifiers
FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size>4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);
Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.
Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;
Negative PD-L1 expression on preoperative pathological examination (Combined positive score < 1);
Disqualifiers
Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;
Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;
Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;
Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;
Trial design
Treatments tested in this trial
- Camrelizumab
- Paclitaxel-albumin
- Cisplatin
- radical surgery
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
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Tianjin Medical University General Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
West China Second University Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator