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References: Hepatocellular carcinoma

89 sources cited on this page. Links open the primary source.

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  16. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, NDA 21-923/S-007 (supersedes S-004, S-005 and S-006), Nexavar (sorafenib). Unresectable hepatocellular carcinoma. Electronically signed 16 November 2007. Source
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  19. Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009;10(1):25-34. PubMedDOI
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  21. van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308(24):2584-93. PubMedDOI
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  22. Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, et al. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015;16(13):1344-54. PubMedDOI
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  23. Zhu AX, Park JO, Ryoo BY, Yen CJ, Poon R, Pastorelli D, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015;16(7):859-70. PubMedDOI
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  24. Lencioni R, Llovet JM, Han G, Tak WY, Yang J, Guglielmi A, et al. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol. 2016;64(5):1090-1098. PubMedDOI
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  25. Reig M, Mariño Z, Perelló C, Iñarrairaegui M, Ribeiro A, Lens S, et al. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol. 2016;65(4):719-726. PubMedDOI
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  26. Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389(10064):56-66. PubMedDOI
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  27. El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017;389(10088):2492-2502. PubMedDOI
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  28. U.S. Food and Drug Administration. OPDIVO (nivolumab) prescribing information, revised 9/2017, enclosed with the approval letter for BLA 125554/S-041 (Reference ID 4156731). Sections 1.8 and 14.8: hepatocellular carcinoma previously treated with sorafenib. Source
  29. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 125554/S-041 (accelerated approval), Opdivo (nivolumab). Single-agent nivolumab, hepatocellular carcinoma previously treated with sorafenib; accelerated approval. Electronically signed 22 September 2017. Source
  30. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, NDA 203085/S-007, Stivarga (regorafenib). Hepatocellular carcinoma previously treated with sorafenib. Electronically signed 27 April 2017. Source
  31. Kanwal F, Kramer J, Asch SM, Chayanupatkul M, Cao Y, El-Serag HB. Risk of Hepatocellular Cancer in HCV Patients Treated With Direct-Acting Antiviral Agents. Gastroenterology. 2017;153(4):996-1005.e1. PubMedDOI
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  32. Vilgrain V, Pereira H, Assenat E, Guiu B, Ilonca AD, Pageaux GP, et al. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2017;18(12):1624-1636. PubMedDOI
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  33. Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, et al. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018;379(1):54-63. PubMedDOI
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  34. Chow PKH, Gandhi M, Tan SB, Khin MW, Khasbazar A, Ong J, et al. SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma. J Clin Oncol. 2018;36(19):1913-1921. PubMedDOI
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  35. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 125514/S-42 (accelerated approval), Keytruda (pembrolizumab). Hepatocellular carcinoma previously treated with sorafenib; accelerated approval. Electronically signed 9 November 2018. Source
  36. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, NDA 206947/S-007, Lenvima (lenvatinib). First-line treatment of unresectable hepatocellular carcinoma. Electronically signed 15 August 2018. Source
  37. Koshiol J, Liu Z, O'Brien TR, Hildesheim A. Beasley's 1981 paper: The power of a well-designed cohort study to drive liver cancer research and prevention. Cancer Epidemiol. 2018;53:195-199. PubMedDOI
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  38. Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018;391(10126):1163-1173. PubMedDOI
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  39. Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, et al. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018;154(6):1706-1718.e1. PubMedDOI
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  40. Zhu AX, Finn RS, Edeline J, Cattan S, Ogasawara S, Palmer D, et al. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. Lancet Oncol. 2018;19(7):940-952. PubMedDOI
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  41. Carrat F, Fontaine H, Dorival C, Simony M, Diallo A, Hezode C, et al. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study. Lancet. 2019;393(10179):1453-1464. PubMedDOI
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  42. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, NDA 208692/S-003, Cabometyx (cabozantinib). Hepatocellular carcinoma previously treated with sorafenib. Electronically signed 14 January 2019. Source
  43. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 125477/S-29, Cyramza (ramucirumab). Hepatocellular carcinoma with alpha fetoprotein of 400 ng/mL or more, treated with sorafenib. Electronically signed 10 May 2019. Source
  44. Zhu AX, Kang YK, Yen CJ, Finn RS, Galle PR, Llovet JM, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(2):282-296. PubMedDOI
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  45. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 125085/S-332, Avastin (bevacizumab). With atezolizumab, unresectable or metastatic hepatocellular carcinoma, no prior systemic therapy. Electronically signed 29 May 2020. Source
  46. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 125554/S-078 (accelerated approval), Opdivo (nivolumab). With ipilimumab, hepatocellular carcinoma previously treated with sorafenib; accelerated approval. Electronically signed 10 March 2020. Source
  47. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 761034/S-25, Tecentriq (atezolizumab). With bevacizumab, unresectable or metastatic hepatocellular carcinoma, no prior systemic therapy. Electronically signed 29 May 2020. Source
  48. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 125377/S-108 (accelerated approval), Yervoy (ipilimumab). With nivolumab, hepatocellular carcinoma previously treated with sorafenib; accelerated approval. Electronically signed 10 March 2020. Source
  49. Finn RS, Ryoo BY, Merle P, Kudo M, Bouattour M, Lim HY, et al. Pembrolizumab As Second-Line Therapy in Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240: A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2020;38(3):193-202. PubMedDOI
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  50. Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-1905. PubMedDOI
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  51. Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, et al. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020;69(8):1492-1501. PubMedDOI
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  52. Mazzaferro V, Citterio D, Bhoori S, Bongini M, Miceli R, De Carlis L, et al. Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial. Lancet Oncol. 2020;21(7):947-956. PubMedDOI
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  53. Abou-Alfa GK, Lau G, Kudo M, Chan SL, Kelley RK, Furuse J, et al. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022;1(8):EVIDoa2100070. PubMedDOI
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  54. Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, et al. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022;76(4):862-873. PubMedDOI
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  55. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BLA 761069/S-36, Imfinzi (durvalumab). With tremelimumab-actl, unresectable hepatocellular carcinoma. Electronically signed 21 October 2022. Source
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