drugset / Trial / NCT04663035
Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma.
Timeline
- Start
- 2020-12-21
- Primary completion
- 2023-12-18
- Completion
- 2025-12-18
Publications
- Background Lyu N, Kong Y, Li X, Mu L, Deng H, Chen H, He M, Lai J, Li J, Tang H, Lin Y, Zhao M. Ablation Reboots the Response in Advanced Hepatocellular Carcinoma With Stable or Atypical Response During PD-1 Therapy: A Proof-of-Concept Study. Front Oncol. 2020 Oct 9;10:580241. doi: 10.3389/fonc.2020.580241. eCollection 2020.
- Background Pan T, Xie QK, Lv N, Li XS, Mu LW, Wu PH, Zhao M. Percutaneous CT-guided Radiofrequency Ablation for Lymph Node Oligometastases from Hepatocellular Carcinoma: A Propensity Score-matching Analysis. Radiology. 2017 Jan;282(1):259-270. doi: 10.1148/radiol.2016151807. Epub 2016 Jul 11.
- Background Deng H, Kan A, Lyu N, Mu L, Han Y, Liu L, Zhang Y, Duan Y, Liao S, Li S, Xie Q, Gao T, Li Y, Zhang Z, Zhao M. Dual Vascular Endothelial Growth Factor Receptor and Fibroblast Growth Factor Receptor Inhibition Elicits Antitumor Immunity and Enhances Programmed Cell Death-1 Checkpoint Blockade in Hepatocellular Carcinoma. Liver Cancer. 2020 Jun;9(3):338-357. doi: 10.1159/000505695. Epub 2020 Feb 25.
- Background Lyu N, Kong Y, Pan T, Mu L, Sun X, Li S, Deng H, Lai J, Zhao M. Survival benefits of computed tomography-guided thermal ablation for adrenal metastases from hepatocellular carcinoma. Int J Hyperthermia. 2019;36(1):1003-1011. doi: 10.1080/02656736.2019.1663279.
- Background Mu L, Pan T, Lyu N, Sun L, Li S, Xie Q, Deng H, Wu P, Liu H, Zhao M. CT-guided percutaneous radiofrequency ablation for lung neoplasms adjacent to the pericardium. Lung Cancer. 2018 Aug;122:25-31. doi: 10.1016/j.lungcan.2018.05.004. Epub 2018 May 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |