Clinical trial NCT05171335 - References

Hepatocellular Carcinoma — Neoadjuvant Combination Therapy of Lenvatinib and TACE for Transplant-Eligible Large Hepatocellular Carcinoma Patients

Citation(s)

•   Bharat A, Brown DB, Crippin JS, Gould JE, Lowell JA, Shenoy S, Desai NM, Chapman WC
  Pre-liver transplantation locoregional adjuvant therapy for hepatocellular carcinoma as a strategy to improve longterm survival. J Am Coll Surg. 2006 Oct;203(4):411-20. Epub 2006 Aug 17.
•   Daoud A, Teeter L, Ghobrial RM, Graviss EA, Mogawer S, Sholkamy A, El-Shazli M, Gaber AO
  Transplantation for Hepatocellular Carcinoma: Is There a Tumor Size Limit? Transplant Proc. 2018 Dec;50(10):3577-3581. doi: 10.1016/j.transproceed.2018.04.038. Epub 2018 Apr 18.
•   Hastie T, Tibshirani R, Wainwright M
  Statistical Learning with Sparsity: The Lasso and Generalizations. Boca Raton, FL: CRC Press; 2015.
•   Highlights of prescribing information: Lenvima
  In:2020.
•   Hsiao P, Hsieh KC, Chen YS, Hsu CC, Lo GH, Li YC, Hsieh PM, Lin HY, Wu TC, Yeh JH, Lin CW
  Sorafenib with concurrent multiple-line therapies improves overall survival in advanced stage hepatocellular carcinoma. Medicine (Baltimore). 2019 Jun;98(25):e16074. doi: 10.1097/MD.0000000000016074.
•   Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL
  Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.
•   Kudo M
  Proposal of Primary Endpoints for TACE Combination Trials with Systemic Therapy: Lessons Learned from 5 Negative Trials and the Positive TACTICS Trial. Liver Cancer. 2018 Sep;7(3):225-234. doi: 10.1159/000492535. Epub 2018 Aug 23.
•   Lee S, Kang JH, Kim DY, Ahn SH, Park JY, Kim BK, Kim SU, Han KH
  Prognostic factors of sorafenib therapy in hepatocellular carcinoma patients with failure of transarterial chemoembolization. Hepatol Int. 2017 May;11(3):292-299. doi: 10.1007/s12072-017-9792-3. Epub 2017 Mar 21.
•   Lencioni R, Llovet JM
  Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19. Review.
•   Lenvima [Package Insert]
  Eisai R&D Management Co., Ltd. http://www.lenvima.com/pdfs/prescribinginformation. pdf. Published 2020. Accessed June 12, 2020.
•   Matsuki M, Hoshi T, Yamamoto Y, Ikemori-Kawada M, Minoshima Y, Funahashi Y, Matsui J
  Lenvatinib inhibits angiogenesis and tumor fibroblast growth factor signaling pathways in human hepatocellular carcinoma models. Cancer Med. 2018 Jun;7(6):2641-2653. doi: 10.1002/cam4.1517. Epub 2018 May 7.
•   Mazzaferro V, Regalia E, Doci R, Andreola S, Pulvirenti A, Bozzetti F, Montalto F, Ammatuna M, Morabito A, Gennari L
  Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis. N Engl J Med. 1996 Mar 14;334(11):693-9.
•   Oligane HC, Xing M, Kim HS
  Effect of Bridging Local-Regional Therapy on Recurrence of Hepatocellular Carcinoma and Survival after Orthotopic Liver Transplantation. Radiology. 2017 Mar;282(3):869-879. doi: 10.1148/radiol.2016160288. Epub 2016 Sep 27.
•   SEER stats
  Liver and intrahepatic bile duct cancer. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Cancer Stat Facts Web site. https://seer.cancer.gov/statfacts/html/livibd.html. Published 2019. Accessed December 8, 2019.
•   Victor DW 3rd, Monsour HP Jr, Boktour M, Lunsford K, Balogh J, Graviss EA, Nguyen DT, McFadden R, Divatia MK, Heyne K, Ankoma-Sey V, Egwim C, Galati J, Duchini A, Saharia A, Mobley C, Gaber AO, Ghobrial RM
  Outcomes of Liver Transplantation for Hepatocellular Carcinoma Beyond the University of California San Francisco Criteria: A Single-center Experience. Transplantation. 2020 Jan;104(1):113-121. doi: 10.1097/TP.0000000000002835.
•   White DL, Thrift AP, Kanwal F, Davila J, El-Serag HB
  Incidence of Hepatocellular Carcinoma in All 50 United States, From 2000 Through 2012. Gastroenterology. 2017 Mar;152(4):812-820.e5. doi: 10.1053/j.gastro.2016.11.020. Epub 2016 Nov 23.
•   Wu FX, Chen J, Bai T, Zhu SL, Yang TB, Qi LN, Zou L, Li ZH, Ye JZ, Li LQ
  The safety and efficacy of transarterial chemoembolization combined with sorafenib and sorafenib mono-therapy in patients with BCLC stage B/C hepatocellular carcinoma. BMC Cancer. 2017 Sep 12;17(1):645. doi: 10.1186/s12885-017-3545-5.
•   Yang JD, Larson JJ, Watt KD, Allen AM, Wiesner RH, Gores GJ, Roberts LR, Heimbach JA, Leise MD
  Hepatocellular Carcinoma Is the Most Common Indication for Liver Transplantation and Placement on the Waitlist in the United States. Clin Gastroenterol Hepatol. 2017 May;15(5):767-775.e3. doi: 10.1016/j.cgh.2016.11.034. Epub 2016 Dec 21.
•   Young S, Sanghvi T, Lake JJ, Rubin N, Golzarian J
  Predicting post-transarterial chemoembolization outcomes: A comparison of direct and total bilirubin serums levels. Diagn Interv Imaging. 2020 Jun;101(6):355-364. doi: 10.1016/j.diii.2019.12.006. Epub 2020 Jan 13.
•   Zhang W, Jin K, Wang F, Zhangyuan G, Yu W, Liu Y, Zhang H, Zhang P, Sun B
  Differences in the prognostic value of tumor size on hepatocellular cancer-specific survival stratified by gender in a SEER population-based study. United European Gastroenterol J. 2019 Aug;7(7):933-941. doi: 10.1177/2050640619845602. Epub 2019 Apr 24.

Neoadjuvant Combination Therapy of Lenvima Plus Transcatheter Arterial Chemoembolization (TACE) for Transplant-Eligible Patients With Large Hepatocellular Carcinoma

Details for clinical trial NCT05171335