drugset / Trial / NCT06288373
Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
Phase 2/3
Recruiting
440 enrolled
Tongji Hospital
Anhui Provincial Cancer Hospital · collabBeijing Friendship Hospital · collabCancer Hospital of Guangxi Medical University · collabGansu Provincial Maternal and Child Health Care Hospital · collabQilu Hospital of Shandong University · collabShengjing Hospital · collabSichuan Cancer Hospital and Research Institute · collabSouthwest Hospital, China · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabTianjin Medical University General Hospital · collabWest China Second University Hospital · collabWomen's Hospital School Of Medicine Zhejiang University · collabXiangya Hospital of Central South University · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.
Timeline
- Start
- 2024-04-22
- Primary completion
- 2031-03-01
- Completion
- 2031-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | — |
| Comparator | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |