Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in NACT for Locally Advanced Cervical Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cervical Cancer
- Chemotherapy Effect
- Neoadjuvant Therapy
- Programmed Cell Death 1 Receptor / Antagonists & Inhibitors
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cyclesMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Only males
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 ...
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.
Tracking Information
- NCT #
- NCT04799639
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jihong Liu, Ph.D. Sun Yat-sen University
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