drugset / Trial / NCT06916117

Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC

NCT06916117 ↗

Phase 2 Not yet recruiting 30 enrolled RenJi Hospital
NaSingle-groupOpen-labelTreatment

Summary

Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.

Timeline

Start
2025-04-05
Primary completion
2026-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 —
Subject Paclitaxel Small molecule 135 mg/m2 —
Subject Paclitaxel Small molecule 175 mg/m2 —
Subject Sintilimab Monoclonal antibody 200 mg —

Indications