To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer
A total of 47 patients will be enrolled in this study. After screening, patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles. CT/MR of chest, upper and lower abdomen and pelvic MR will be performed before treatment and 2 weeks after the 3rd cycle chemotherapy. The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1. Radical surgery will be performed after NACT. According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated. The adverse events will be continuously monitored during treatment until 30 days after chemotherapy. Toxic adverse events is evaluated according to NCI-CTCAEv5.0 criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China
pathological complete remission rate (pCR) rate
According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated.
Time frame: 3 months
objective response rate (ORR) (CR + PR)
The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1.
Time frame: 3 months
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