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.
This study will enroll patients with IB3 and IIA2 locally advanced cervical cancer who received three cycles of neoadjuvant Zimberelimab combined with albumin-bound paclitaxel and cisplatin to evaluate the efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Hongxi Zhao
Xi'an, Shaanxi, China
RECRUITINGObjective 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
Time frame: 3-4 months
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.
Time frame: one year
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.
Time frame: one year
R0 resection rate
R0 resection rate: defined as the proportion of patients undergoing surgical excision who had a negative margin of surgical specimens
Time frame: one year
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.
Time frame: three years
Overall survival (OS)
Overall survival (OS) : defined as the time between the initiation of treatment and death from any cause.
Time frame: three years
Adverse Events
Based on NCI-CTC AE v5.0
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Time frame: three years