drugset / Trial / NCT03864211
Thermal Ablation Followed by Immunotherapy for HCC
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and efficacy of immunotherapy toripalimab (anti-PD-1 mAb) combined with thermal ablation in patients with Hepatocellular Carcinoma (HCC).
Timeline
- Start
- 2019-06-15
- Primary completion
- 2023-05-30
- Completion
- 2023-05-30
Publications
- Background Shi L, Chen L, Wu C, Zhu Y, Xu B, Zheng X, Sun M, Wen W, Dai X, Yang M, Lv Q, Lu B, Jiang J. PD-1 Blockade Boosts Radiofrequency Ablation-Elicited Adaptive Immune Responses against Tumor. Clin Cancer Res. 2016 Mar 1;22(5):1173-1184. doi: 10.1158/1078-0432.CCR-15-1352.
- Background Chu KF, Dupuy DE. Thermal ablation of tumours: biological mechanisms and advances in therapy. Nat Rev Cancer. 2014 Mar;14(3):199-208. doi: 10.1038/nrc3672.
- Background Ulahannan SV, Duffy AG. Hepatocellular carcinoma and immune therapy, from a clinical perspective; where are we? Hepat Oncol. 2016 Aug;3(3):183-185. doi: 10.2217/hep-2016-0008. Epub 2016 Aug 19. No abstract available.
- Background Keam SJ. Toripalimab: First Global Approval. Drugs. 2019 Apr;79(5):573-578. doi: 10.1007/s40265-019-01076-2.
- Background Hwang WL, Pike LRG, Royce TJ, Mahal BA, Loeffler JS. Safety of combining radiotherapy with immune-checkpoint inhibition. Nat Rev Clin Oncol. 2018 Aug;15(8):477-494. doi: 10.1038/s41571-018-0046-7.
- Background Taube JM, Klein A, Brahmer JR, Xu H, Pan X, Kim JH, Chen L, Pardoll DM, Topalian SL, Anders RA. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-PD-1 therapy. Clin Cancer Res. 2014 Oct 1;20(19):5064-74. doi: 10.1158/1078-0432.CCR-13-3271. Epub 2014 Apr 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |