drugset / Trial / NCT06289062
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
Phase 2
Recruiting
40 enrolled
Tongji Hospital
Anhui Provincial Cancer Hospital · collabBeijing Friendship Hospital · collabGansu Cancer Hospital · collabQilu Hospital of Shandong University · collabShengjing Hospital · collabSichuan Cancer Hospital and Research Institute · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThird Military Medical University · collabTianjin Medical University · collabWest China Second University Hospital · collabWomen's Hospital School Of Medicine Zhejiang University · collabXiangya Hospital of Central South University · collabZhejiang Cancer Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, EFS and OS.
Timeline
- Start
- 2024-05-08
- Primary completion
- 2025-12-01
- Completion
- 2030-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 260 mg/m2 | Intravenous |