drugset / Trial / NCT05768464
Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors
Phase 2
Recruiting
30 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NaSingle-groupOpen-labelTreatment
Summary
The goal of this prospective, multicenter, single-arm clinical study is to evaluate the efficacy and safety of toripalimab in combination with axitinib for postoperative adjuvant therapy for non-clear renal cell carcinoma with high-risk recurrence factors.
Timeline
- Start
- 2023-02-01
- Primary completion
- 2026-12-30
- Completion
- 2027-12-30
Publications
- Background Liu T, Zhang M, Sun D. Immune Cell Infiltration and Identifying Genes of Prognostic Value in the Papillary Renal Cell Carcinoma Microenvironment by Bioinformatics Analysis. Biomed Res Int. 2020 Jul 25;2020:5019746. doi: 10.1155/2020/5019746. eCollection 2020.
- Background Lobo J, Ohashi R, Amin MB, Berney DM, Comperat EM, Cree IA, Gill AJ, Hartmann A, Menon S, Netto GJ, Raspollini MR, Rubin MA, Tan PH, Tickoo SK, Tsuzuki T, Turajlic S, Zhou M, Srigley JR, Moch H. WHO 2022 landscape of papillary and chromophobe renal cell carcinoma. Histopathology. 2022 Oct;81(4):426-438. doi: 10.1111/his.14700. Epub 2022 Jun 10.
- Background Steffens S, Janssen M, Roos FC, Becker F, Schumacher S, Seidel C, Wegener G, Thuroff JW, Hofmann R, Stockle M, Siemer S, Schrader M, Hartmann A, Kuczyk MA, Junker K, Schrader AJ. Incidence and long-term prognosis of papillary compared to clear cell renal cell carcinoma--a multicentre study. Eur J Cancer. 2012 Oct;48(15):2347-52. doi: 10.1016/j.ejca.2012.05.002. Epub 2012 Jun 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axitinib | Small molecule | 5 mg | Oral |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |