NCT04799639

Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in NACT for Locally Advanced Cervical Cancer

Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer

Detailed description

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.

Conditions

• Cervical Cancer
• Chemotherapy Effect
• Programmed Cell Death 1 Receptor / Antagonists & Inhibitors
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	Sindilimab +paclitaxel+ cisplantin	standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles

Timeline

• Start date: 2021-03-18
• Primary completion: 2024-06-17
• Completion: 2024-06-24
• First posted: 2021-03-16
• Last updated: 2024-06-25

Locations

1 site across 1 country: China