drugset / Trial / NCT04735861
Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma
Phase 2
Completed
38 enrolled
Tongji Hospital
Anhui Provincial Cancer Hospital · collabCancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital · collabHenan Cancer Hospital · collabHubei Cancer Hospital · collabJingzhou Central Hospital · collabQilu Hospital of Shandong University · collabShengjing Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First People's Hospital of Jingzhou · collabUnion Hospital affiliated to Tongji Medical College · collabXiangyang Central Hospital · collabZhongnan Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
Ovarian clear cell carcinoma (OCCC) is one of the rare subtypes of ovarian cancer, yet its prognosis is extremely poor. Previous studies indicate that both bevacizumab and PD-1 inhibitor have clinical benefits for OCCC patients. And the combination of bevacizumab and PD-1 inhibitor has shown preliminary safety and clinical activity. Therefore, this study aims to investigate the potential benefit of combination therapy for patients with OCCC.
Timeline
- Start
- 2021-04-07
- Primary completion
- 2024-07-30
- Completion
- 2024-07-30
Publications
- Peng Z, Li H, Gao Y, Sun L, Jiang J, Xia B, Huang Y, Zhang Y, Xia Y, Zhang Y, Shen Y, Huang B, Nie J, Chen X, Liu X, Feng C, Li Z, Zhang W, Tao K, Zhang Q, Duan S, Chen Y, Chen Y, Wang W, Zheng H, Lu Y, Liu Y, Wang L, Qi W, He Y, Tian Y; NUWA Platform Research Group; Li G, Ma D, Gao Q. Sintilimab combined with bevacizumab in relapsed or persistent ovarian clear cell carcinoma (INOVA): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Oct;25(10):1288-1297. doi: 10.1016/S1470-2045(24)00437-6. Epub 2024 Sep 11.
- Li R, Liu X, Song C, Zhang W, Liu J, Jiao X, Yu Y, Zeng S, Chi J, Zhao Y, Ma G, Huo Y, Li M, Peng Z, Li G, Jiang J, Gao QL. Sintilimab combined with bevacizumab in relapsed/persistent ovarian clear cell carcinoma (INOVA): an investigator-initiated, multicentre clinical trial-a study protocol of clinical trial. BMJ Open. 2022 May 24;12(5):e058132. doi: 10.1136/bmjopen-2021-058132.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |