A Phase 2 interventional study of Sindilimab +paclitaxel+ cisplantin in Cervical Cancer, Chemotherapy Effect and Programmed Cell Death 1 Receptor / Antagonists & Inhibitors, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 47 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles paclitaxel 150mg/m2,ivdrip,\>3 hours cisplantin 70mg/m2,ivdrip,\>1 hours Sindilimab 200mg,ivdrip, \>0.5 hours
Drug: Sindilimab +paclitaxel+ cisplantin
standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles
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
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University