drugset / Trial / NCT05173272

Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer

NCT05173272

Phase 3 Recruiting 286 enrolled Sichuan Cancer Hospital and Research Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates. Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone. 286 patients will be recruited during 2 years, with 3 years of follow up period.

Timeline

Start
2023-07-24
Primary completion
2027-12-28
Completion
2028-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 30 mg/m2
Subject Cisplatin Other / unclassified 40 mg/m2
Subject Cisplatin Other / unclassified 50 mg/m2
Subject Paclitaxel Small molecule 175 mg/m2
Subject Serplulimab Monoclonal antibody 300 mg

Indications