drugset / Trial / NCT05173272
Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |