Hepatocellular carcinoma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main HCC page for regimens that include active anticancer treatment.
=Adjuvant therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Takayama et al. 2000 (IIC-I01) 	1992-1995 	Phase 3 (C)	Adoptive immunotherapy 	Shorter RFS
Chen et al. 2012 (T1297) 	1997-2003 	Phase 3 (C)	Interferon alfa-2b 	Did not meet primary endpoint of RFS
Wang et al. 2018 (LCI-125-009) 	2011-2014 	Phase 3 (C)	TACE 	Seems to have shorter OSOS36: 77.4% vs 85.2%(HR 1.69, 95% CI 1.03-2.78)
Li et al. 2023 (B2017-006-01) 	2016-06 to 2021-08 	Phase 3 (C)	FOLFOX-HAIC x 1 to 2 	Shorter DFS
Qin et al. 2023 (IMbrave050) 	2019-12-31 to 2021-11-25	Phase 3 (C)	Atezolizumab & Bevacizumab	Seems to have shorter RFS
Awaiting publication (SHR-1210-III-325)	2021-ongoing 	Phase 3 (C)	Apatinib & Camrelizumab 	TBD if different primary endpoint of RFS
No treatment after surgery or ablation.
====Preceding treatment====
*Curative surgical resection or ablation
===References===
#IIC-I01: Takayama T, Sekine T, Makuuchi M, Yamasaki S, Kosuge T, Yamamoto J, Shimada K, Sakamoto M, Hirohashi S, Ohashi Y, Kakizoe T. Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet. 2000 Sep 2;356(9232):802-7. Erratum in: Lancet 2000 Nov 11;356(9242):1690. link to original article EuroPMC NCT00699816
#T1297: Chen LT, Chen MF, Li LA, Lee PH, Jeng LB, Lin DY, Wu CC, Mok KT, Chen CL, Lee WC, Chau GY, Chen YS, Lui WY, Hsiao CF, Whang-Peng J, Chen PJ; Disease Committee of Adjuvant Therapy for Postoperative Hepatocellular Carcinoma, Taiwan Cooperative Oncology Group, National Health Research Institutes, Zhunan, Taiwan. Long-term results of a randomized, observation-controlled, phase III trial of adjuvant interferon alfa-2b in hepatocellular carcinoma after curative resection. Ann Surg. 2012 Jan;255(1):8-17. link to original article EuroPMC NCT00149565
#LCI-125-009: Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant transarterial chemoembolization for HBV-related hepatocellular carcinoma after resection: a randomized controlled study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. Epub 2018 Feb 2. link to original article EuroPMC NCT01966133
#B2017-006-01: Li SH, Mei J, Cheng Y, Li Q, Wang QX, Fang CK, Lei QC, Huang HK, Cao MR, Luo R, Deng JD, Jiang YC, Zhao RC, Lu LH, Zou JW, Deng M, Lin WP, Guan RG, Wen YH, Li JB, Zheng L, Guo ZX, Ling YH, Chen HW, Zhong C, Wei W, Guo RP. Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study. J Clin Oncol. 2023 Apr 1;41(10):1898-1908. Epub 2022 Dec 16. link to original article link to PMC article EuroPMC NCT03192618
#IMbrave050: Qin S, Chen M, Cheng AL, Kaseb AO, Kudo M, Lee HC, Yopp AC, Zhou J, Wang L, Wen X, Heo J, Tak WY, Nakamura S, Numata K, Uguen T, Hsiehchen D, Cha E, Hack SP, Lian Q, Ma N, Spahn JH, Wang Y, Wu C, Chow PKH; IMbrave050 investigators. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Nov 18;402(10415):1835-1847. Epub 2023 Oct 20. link to original article EuroPMC NCT04102098
#SHR-1210-III-325: NCT04639180
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Kudo et al. 2011 (Bayer 11721) 	2006-2009 	Phase 3 (C)	Sorafenib 	Did not meet primary endpoint of TTP
Bruix et al. 2015 (STORMHCC) 	2008-2010 	Phase 3 (C)	Sorafenib 	Did not meet primary endpoint of RFS
Awaiting publication (CheckMate 9DX)	2018-ongoing 	Phase 3 (C)	Nivolumab 	TBD if different primary endpoint of RFS
Awaiting publication (EMERALD-2) 	2019-ongoing 	Phase 3 (C)	1. Durvalumab2. Bevacizumab & Durvalumab	TBD if different primary endpoint of RFS
Awaiting publication (JUPITER 04) 	2019-ongoing 	Phase 3 (C)	Toripalimab 	TBD if different primary endpoint of RFS
Awaiting publication (KEYNOTE-937) 	2019-ongoing 	Phase 3 (C)	Pembrolizumab 	TBD if different co-primary endpoints of RFS/OS
No active antineoplastic treatment. Note that there is another STORM trial in multiple myeloma.
====Preceding treatment====
*Bayer 11721: TACE x 1-2
*STORM: Resection or ablation
===References===
#Bayer 11721: Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. link to original article EuroPMC NCT00494299
#STORMHCC: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. Epub 2015 Sep 8. link to original article EuroPMC NCT00692770
##Dataset: Project Data Sphere
#CheckMate 9DX: NCT03383458
#EMERALD-2: NCT03847428
#JUPITER 04: NCT03859128
#KEYNOTE-937: NCT03867084
=First-line therapy for advanced or metastatic disease=
==Best supportive care==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Trinchet et al. 1995 	1990-1992 	Phase 3 (C)	TACE 	Did not meet primary endpoint of OS
Gallo et al. 1998 (CLIP-1)	1995-1997 	Phase 3 (C)	Tamoxifen 	Did not meet primary endpoint of OS
Llovet et al. 2002 	1996-2000 	Phase 3 (C)	TACE 	Shorter OS(HR 2.13, 95% CI 1.10-4.00)
No antineoplastic treatment.
===References===
#Trinchet JC, Abou Rached A, Beaugrand M, Mathieu D, Chevret S, Chastang C; Groupe d'Etude et de Traitement du Carcinome Hépatocellulaire. A comparison of lipiodol chemoembolization and conservative treatment for unresectable hepatocellular carcinoma. N Engl J Med. 1995 May 11;332(19):1256-61. link to original article EuroPMC
#CLIP-1: Gallo C, Daniele B, Gaeta GB, Perrone F, Pignata S; CLIP Group (Cancer of the Liver Italian Programme). Tamoxifen in treatment of hepatocellular carcinoma: a randomised controlled trial. Lancet. 1998 Jul 4;352(9121):17-20. link to original article EuroPMC
#Llovet JM, Real MI, Montaña X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Solà R, Rodés J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. link to original article EuroPMC
==Placebo==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Chow et al. 2002 (NMRC-AHCC01) 	1997-2000 	Phase 3 (C)	1. Tamoxifen; 60 mg/day2. Tamoxifen; 120 mg/day	Seems to have longer OS
Chow et al. 2011 (NMRC-AHCC02) 	2002-2007 	Phase 3 (C)	Megestrol 	Did not meet primary endpoint of OSMedian OS: 2.14 vs 1.88 mo(HR 0.80, 95% CI 0.58-1.09)
Llovet et al. 2008 (SHARP) 	2005-03-10 to 2006-04-11	Phase 3 (C)	Sorafenib 	Shorter OSMedian OS: 7.9 vs 10.7 mo(HR 1.45, 95% CI 1.15-1.82)
Cheng et al. 2008 (Sorafenib AP)	2005-2007 	Phase 3 (C)	Sorafenib 	No predetermined endpoint; inferior OSMedian OS: 4.2 vs 6.5 mo(HR 1.47, 95% CI 1.08-2.00)
No active antineoplastic treatment.
===References===
#NMRC-AHCC01: Chow PK, Tai BC, Tan CK, Machin D, Win KM, Johnson PJ, Soo KC; Asian-Pacific Hepatocellular Carcinoma Trials Group. High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: a multicenter randomized controlled trial. Hepatology. 2002 Nov;36(5):1221-6. link to original article EuroPMC NCT00003424
#SHARP: Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. link to original article EuroPMC NCT00105443
##Subgroup analysis: Bruix J, Raoul JL, Sherman M, Mazzaferro V, Bolondi L, Craxi A, Galle PR, Santoro A, Beaugrand M, Sangiovanni A, Porta C, Gerken G, Marrero JA, Nadel A, Shan M, Moscovici M, Voliotis D, Llovet JM. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma: subanalyses of a phase III trial. J Hepatol. 2012 Oct;57(4):821-9. Epub 2012 Jun 19. link to original article EuroPMC
#Sorafenib AP: Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. 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 Jan;10(1):25-34. Epub 2008 Dec 16. link to original article EuroPMC NCT00492752
##Subgroup analysis: Cheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jul;48(10):1452-65. Epub 2012 Jan 10. link to original article EuroPMC
#NMRC-AHCC02: Chow PK, Machin D, Chen Y, Zhang X, Win KM, Hoang HH, Nguyen BD, Jin MY, Lobo R, Findlay M, Lim CH, Tan SB, Gandhi M, Soo KC; Asia-Pacific Hepatocellular Carcinoma Trials Group. Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma. Br J Cancer. 2011 Sep 27;105(7):945-52. Epub 2011 Aug 23. link to original article link to PMC article EuroPMC NCT00041275
=Advanced or metastatic disease, second-line=
==Placebo==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Zhu et al. 2015 (REACH-HCC) 	2010-2013 	Phase 3 (C)	Ramucirumab 	Did not meet primary endpoint of OS
Rimassa et al. 2018 (METIV-HCC) 	2012-12-27 to 2015-12-10	Phase 3 (C)	Tivantinib 	Did not meet primary endpoint of OS
Bruix et al. 2016 (RESORCE) 	2013-05-14 to 2015-12-31	Phase 3 (C)	Regorafenib 	Shorter OSMedian OS: 7.8 vs 10.6 mo(HR 1.59, 95% CI 1.27-2.00)
Abou-Alfa et al. 2018 (POLARIS 2009-001)	Not reported 	Phase 3 (C)	ADI-PEG 20 	Did not meet primary endpoint of OS
Zhu et al. 2019 (REACH-2) 	2015-2017 	Phase 3 (C)	Ramucirumab 	Shorter OSMedian OS: 7.3 vs 8.5 mo(HR 1.41, 95% CI 1.05-1.89)
Finn et al. 2020 (KEYNOTE-240) 	2016-05-31 to 2017-11-23	Phase 3 (C)	Pembrolizumab	Seems to have shorter OS
====Prior treatment criteria====
*REACH-HCC, METIV-HCC, RESORCE, REACH-2, KEYNOTE-240: Sorafenib
*POLARIS 2009-001: At least one prior systemic therapy with progression and/or TRAE requiring treatment discontinuation
No active antineoplastic treatment. Note that REACH should not be confused for the trial of the same name in CLL.
===References===
#REACH: Zhu AX, Park JO, Ryoo BY, Yen CJ, Poon R, Pastorelli D, Blanc JF, Chung HC, Baron AD, Pfiffer TE, Okusaka T, Kubackova K, Trojan J, Sastre J, Chau I, Chang SC, Abada PB, Yang L, Schwartz JD, Kudo M; REACH Trial Investigators. 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 Jul;16(7):859-70. Epub 2015 Jun 18. link to original article EuroPMC NCT01140347
#RESORCE: Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Breder V, Gerolami R, Masi G, Ross PJ, Song T, Bronowicki JP, Ollivier-Hourmand I, Kudo M, Cheng AL, Llovet JM, Finn RS, LeBerre MA, Baumhauer A, Meinhardt G, Han G; RESORCE Investigators. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Jan 7;389(10064):56-66. Epub 2016 Dec 6. Erratum in: Lancet. 2017 Jan 7;389(10064):36. link to original article EuroPMC NCT01774344
#METIV-HCC: Rimassa L, Assenat E, Peck-Radosavljevic M, Pracht M, Zagonel V, Mathurin P, Rota Caremoli E, Porta C, Daniele B, Bolondi L, Mazzaferro V, Harris W, Damjanov N, Pastorelli D, Reig M, Knox J, Negri F, Trojan J, López López C, Personeni N, Decaens T, Dupuy M, Sieghart W, Abbadessa G, Schwartz B, Lamar M, Goldberg T, Shuster D, Santoro A, Bruix J. Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study. Lancet Oncol. 2018 May;19(5):682-693. Epub 2018 Apr 3. link to original article EuroPMC NCT01755767
#POLARIS 2009-001: Abou-Alfa GK, Qin S, Ryoo BY, Lu SN, Yen CJ, Feng YH, Lim HY, Izzo F, Colombo M, Sarker D, Bolondi L, Vaccaro G, Harris WP, Chen Z, Hubner RA, Meyer T, Sun W, Harding JJ, Hollywood EM, Ma J, Wan PJ, Ly M, Bomalaski J, Johnston A, Lin CC, Chao Y, Chen LT. Phase III randomized study of second line ADI-PEG 20 plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma. Ann Oncol. 2018 Jun 1;29(6):1402-1408. link to original article EuroPMC NCT01287585
#REACH-2: Zhu AX, Kang YK, Yen CJ, Finn RS, Galle PR, Llovet JM, Assenat E, Brandi G, Pracht M, Lim HY, Rau KM, Motomura K, Ohno I, Merle P, Daniele B, Shin DB, Gerken G, Borg C, Hiriart JB, Okusaka T, Morimoto M, Hsu Y, Abada PB, Kudo M; REACH-2 study investigators. 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 Feb;20(2):282-296. Epub 2019 Jan 18. link to original article EuroPMC NCT02435433
#KEYNOTE-240: Finn RS, Ryoo BY, Merle P, Kudo M, Bouattour M, Lim HY, Breder V, Edeline J, Chao Y, Ogasawara S, Yau T, Garrido M, Chan SL, Knox J, Daniele B, Ebbinghaus SW, Chen E, Siegel AB, Zhu AX, Cheng AL; KEYNOTE-240 investigators. 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 Jan 20;38(3):193-202. Epub 2019 Dec 2. link to original article EuroPMC NCT02702401
##Update: Merle P, Kudo M, Edeline J, Bouattour M, Cheng AL, Chan SL, Yau T, Garrido M, Knox J, Daniele B, Breder V, Lim HY, Ogasawara S, Cattan S, Chao Y, Siegel AB, Martinez-Forero I, Wei Z, Liu CC, Finn RS. Pembrolizumab as Second-Line Therapy for Advanced Hepatocellular Carcinoma: Longer Term Follow-Up from the Phase 3 KEYNOTE-240 Trial. Liver Cancer. 2023 Feb 14;12(4):309-320. link to original article link to PMC article EuroPMC
=Subsequent lines of therapy=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Barbare et al. 2009 	2002-07 to 2003-10 	Phase 3 (C)	Octreotide LAR	Did not meet primary endpoint of OS
Dollinger et al. 2010 	2002-2005 	Phase 3 (C)	Thymostimulin 	Did not meet primary endpoint of OS12
Llovet et al. 2013 (BRISK-PS) 	2009-2011 	Phase 3 (C)	Brivanib 	Did not meet primary endpoint of OS
Kudo et al. 2017 (S-CUBE) 	2009-2012 	Phase 3 (C)	S-1 	Did not meet primary endpoint of OS
Zhu et al. 2014 (EVOLVE-1) 	2010-2012 	Phase 3 (C)	Everolimus 	Did not meet primary endpoint of OS
Abou-Alfa et al. 2018 (CELESTIAL)	2013-2017 	Phase 3 (C)	Cabozantinib 	Shorter OSMedian OS: 8 vs 10.2 mo(HR 1.32, 95% CI 1.09-1.59)
Kudo et al. 2020 (JET-HCC) 	2014-2016 	Phase 3 (C)	Tivantinib 	Might have shorter PFS
Qin et al. 2021 (AHELP) 	2014-2017 	Phase 3 (C)	Apatinib 	Seems to have shorter OSMedian OS: 6.8 vs 8.7 mo(HR 1.27, 95% CI 1.002-1.61)
No active antineoplastic treatment.
===References===
#Barbare JC, Bouché O, Bonnetain F, Dahan L, Lombard-Bohas C, Faroux R, Raoul JL, Cattan S, Lemoine A, Blanc JF, Bronowicki JP, Zarski JP, Cazorla S, Gargot D, Thevenot T, Diaz E, Bastie A, Aparicio T, Bedenne L. Treatment of advanced hepatocellular carcinoma with long-acting octreotide: a phase III multicentre, randomised, double blind placebo-controlled study. Eur J Cancer. 2009 Jul;45(10):1788-97. Epub 2009 Mar 19. link to original article EuroPMC
#Dollinger MM, Lautenschlaeger C, Lesske J, Tannapfel A, Wagner AD, Schoppmeyer K, Nehls O, Welker MW, Wiest R, Fleig WE; AIO Hepatobiliary Study Group. Thymostimulin versus placebo for palliative treatment of locally advanced or metastasised hepatocellular carcinoma: a phase III clinical trial. BMC Cancer. 2010 Aug 24;10:457. link to original article link to PMC article EuroPMC ISRCTN64487365
#BRISK-PS: Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. Epub 2013 Aug 26. link to original article EuroPMC NCT00825955
#EVOLVE-1: Zhu AX, Kudo M, Assenat E, Cattan S, Kang YK, Lim HY, Poon RT, Blanc JF, Vogel A, Chen CL, Dorval E, Peck-Radosavljevic M, Santoro A, Daniele B, Furuse J, Jappe A, Perraud K, Anak O, Sellami DB, Chen LT. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA. 2014 Jul 2;312(1):57-67. link to original article EuroPMC NCT01035229
#S-CUBE: Kudo M, Moriguchi M, Numata K, Hidaka H, Tanaka H, Ikeda M, Kawazoe S, Ohkawa S, Sato Y, Kaneko S, Furuse J, Takeuchi M, Fang X, Date Y, Takeuchi M, Okusaka T. S-1 versus placebo in patients with sorafenib-refractory advanced hepatocellular carcinoma (S-CUBE): a randomised, double-blind, multicentre, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):407-417. Epub 2017 Apr 6. link to original article EuroPMC JapicCTI-090920
#CELESTIAL: Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, Cicin I, Merle P, Chen Y, Park JW, Blanc JF, Bolondi L, Klümpen HJ, Chan SL, Zagonel V, Pressiani T, Ryu MH, Venook AP, Hessel C, Borgman-Hagey AE, Schwab G, Kelley RK. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63. link to original article link to PMC article EuroPMC NCT01908426
#JET-HCC: Kudo M, Morimoto M, Moriguchi M, Izumi N, Takayama T, Yoshiji H, Hino K, Oikawa T, Chiba T, Motomura K, Kato J, Yasuchika K, Ido A, Sato T, Nakashima D, Ueshima K, Ikeda M, Okusaka T, Tamura K, Furuse J. A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma. Cancer Sci. 2020 Oct;111(10):3759-3769. Epub 2020 Aug 26. link to original article link to PMC article EuroPMC NCT02029157
#AHELP: Qin S, Li Q, Gu S, Chen X, Lin L, Wang Z, Xu A, Chen X, Zhou C, Ren Z, Yang L, Xu L, Bai Y, Chen L, Li J, Pan H, Cao B, Fang W, Wu W, Wang G, Cheng Y, Yu Z, Zhu X, Jiang D, Lu Y, Wang H, Xu J, Bai L, Liu Y, Lin H, Wu C, Zhang Y, Yan P, Jin C, Zou J. Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):559-568. Epub 2021 May 7. link to original article EuroPMC NCT02329860
#KEYNOTE-394: Qin S, Chen Z, Fang W, Ren Z, Xu R, Ryoo BY, Meng Z, Bai Y, Chen X, Liu X, Xiao J, Ho GF, Mao Y, Wang X, Ying J, Li J, Zhong W, Zhou Y, Siegel AB, Hao C. Pembrolizumab Versus Placebo as Second-Line Therapy in Patients From Asia With Advanced Hepatocellular Carcinoma: A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2023 Mar 1;41(7):1434-1443. Epub 2022 Dec 1. link to original article link to PMC article EuroPMC NCT03062358
##HRQoL analysis: Qin S, Fang W, Ren Z, Ou S, Lim HY, Zhang F, Lee KC, Choi HJ, Tong J, Tao M, Xu A, Cheng A, Lu CH, Chiu CF, Abdul Wahid MI, Kamble S, Norquist JM, Zhong W, Li C, Chen Z. A Phase 3 Study of Pembrolizumab versus Placebo for Previously Treated Patients from Asia with Hepatocellular Carcinoma: Health-Related Quality of Life Analysis from KEYNOTE-394. Liver Cancer. 2024 Jan 10;13(4):389-400. link to original article link to PMC article EuroPMC
Category:Hepatocellular carcinoma regimens
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Category:Hepatobiliary cancers
Category:Null regimens