drugset / Trial / NCT04954339
DYNAmic Immune Microenvironment of HCC Treated With atezolIzumab Plus bevaCizumab
NaSingle-groupOpen-labelTreatment
Summary
Part I (Clinical trial setting): A single-arm phase II study to investigate the efficacy of neoadjuvant atezolizumab (T) + bevacizumab (A) in patients with potentially resectable BCLC stage B/C or high risk resectable hepatocellular carcinoma (HCC) (n = 40) Part II (Biomarker study setting): Exploratory translational research will be conducted using samples obtained from Part 1 (n =40) and those acquired from an independent cohort of treatment-naïve HCC patients (n = 15).
Timeline
- Start
- 2021-10-29
- Primary completion
- 2025-10-10
- Completion
- 2026-05-26
Publications
- Background Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background El-Serag HB. Hepatocellular carcinoma. N Engl J Med. 2011 Sep 22;365(12):1118-27. doi: 10.1056/NEJMra1001683. No abstract available.
- Background Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.
- Background Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
- Background Chan AWH, Zhong J, Berhane S, Toyoda H, Cucchetti A, Shi K, Tada T, Chong CCN, Xiang BD, Li LQ, Lai PBS, Mazzaferro V, Garcia-Finana M, Kudo M, Kumada T, Roayaie S, Johnson PJ. Development of pre and post-operative models to predict early recurrence of hepatocellular carcinoma after surgical resection. J Hepatol. 2018 Dec;69(6):1284-1293. doi: 10.1016/j.jhep.2018.08.027. Epub 2018 Sep 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | — |
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | — |