This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.
Voluntary participation in clinical research.
Age ≥18 years old, female.
Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology.
Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) .
Patients with active autoimmune disease or a history of autoimmune disease.
Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).
Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug).
Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody.
Single group
Zimberelimab
Drug240mg,d1,iv,Q21D
Albumin-bound Paclitaxel
Drug260mg/m2,d1,iv,Q21D
Cisplatin
Drug75mg/m2,d1,iv,Q21D
Objective response rate (ORR)
Objective response rate based on RECIST v1.1, ORR was defined as the ratio of best complete response (CR) and partial response (PR) recorded from the start of treatment to the preoperative evaluation
Complete pathological response (pCR)
Complete pathological response (pCR) was defined as the proportion of all surgical patients in whom no viable tumor cells were found in the resected specimen.
Major Pathological Response (MPR)
Major pathological response (MPR) was defined as the proportion of patients with ≤10% residual viable tumor cells in the resected specimen among all surgical patients.
R0 resection rate
R0 resection rate: defined as the proportion of patients undergoing surgical excision who had a negative margin of surgical specimens
Event-free survival (EFS)
Event-free survival (EFS) was defined as the time from the start of treatment to the first occurrence of any of the following events: disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc.
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