About this trial
This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.
Eligibility criteria
Qualifiers
Clinical diagnosis of untreated stage IB cervical cancer with IB2 (FIGO, 2018 criteria; 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 (any grade), usual type adenocarcinoma (G1 or G2 / Silva A or B), and adenosquamous carcinoma (G1 or G2);
Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;
Disqualifiers
Subjects with an 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 mechanism of tumor immune action;
Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;
Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> 10 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
- Cadonilimab
- Paclitaxel-albumin
- Cisplatin
- Extrafascial hysterectomy
- Radical hysterectomy
- Cone biopsy
Treatment groups
Sponsors and collaborators
Tongji Hospital
Lead sponsor
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Southwest Hospital, China
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Qilu Hospital of Shandong University
Collaborator
Beijing Friendship Hospital
Collaborator
Tianjin Medical University
Collaborator
West China Second University Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator