Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma.

"Conflict of Interest Statement Kudo M.: Lecture: Eisai, Bayer, MSD, BMS, EA Pharma, Eli Lilly, Chugai; Grants: Eisai, Takeda, Otsuka, Taiho, EA Pharma, Gilead Sciences, Abbvie, Sumitomo Dainippon Pharma, Chugai, Ono Pharma; Advisory Consulting: Eisai, Ono, MSD, BMS, Roche. Masatoshi Kudo is Editor-in-Chief of Liver Cancer. Ueshima K.: Honoraria from Bayer AG, Eisai Co. Ltd., Merck Sharp & Dohme, Eli Lilly and Company, Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Pfizer Inc., Otsuka Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taiho Pharmaceutical. Co. Ltd., EA Pharma Co., Ltd., and Kowa Co., Ltd.; Consulting or advisory fees from Eisai Co. Ltd., Eli Lilly and Company, Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Pfizer Inc. Kazuomi Ueshima is an Editorial Board Member of Liver Cancer. Ikeda M. reports grants and personal fees from Bayer, grants and personal fees from Eisai, grants and personal fees from Eli Lilly Japan, grants and personal fees from Chugai Pharmaceutical, grants and personal fees from AstraZeneca, grants and personal fees from Merck Sharp & Dohme, grants from Novartis, grants from Bristol Myers Squibb, grants from Merck Serono, personal fees from Sumitomo Dainippon Pharma, grants and personal fees from Takeda, outside the submitted work. Masafumi Ikeda is an Editorial Board Member of Liver Cancer. Aikata H.: Lecture: Eisai, Bayer. Izumi N.: Receiver speaker bureau from Bayer, Eisai, Lily, and Chugai. Namiki Izumi is an Associate Editor Member of Liver Cancer. Kuzuya T.: Lecture: Eisai, Bayer, Eli Lilly; Grants: Eisai. Isoda N.: Grants: GK, Eisai. Moriguchi M.: Honoraria: Eisai, Bayer, MSD, Eli Lilly, Chugai; Advisory Consulting: Bayer, Eli Lilly, Chugai. Ogasawara S.: Lecture: Eisai, Bayer, MDS, EA Pharma, Eli Lilly, Chugai, Takeda; Grants: Eisai, Bayer, Eli Lilly, AstraZeneca, Chugai; Advisory Consulting: Eisai, Chugai, Roche, AstraZeneca. Yoshimura K.: Lecture: AstraZeneca, Chugai Pharmaceutical Co., Ltd., Eizai, Otsuka, Nihon Kayaku, Elli Lilly, Taiho, Novartis, Boehringer Ingelheim, BrightPath Biotherapeutics, and Nihon Shinyaku, outside the submitted work. Okusaka T.: Consulting/advisory role: Taiho Pharmaceutical, Daiichi Sankyo, Sumitomo Dainippon Pharma, Bristol Myers Squibb, AstraZeneca, Eisai, and Nihon Servier; Research funding: Eli Lilly Japan, MSD, AstraZeneca, Eisai, Chugai Pharmaceutical, Novartis Pharma, Sumitomo Dainippon Pharma, Bristol Myers Squibb, Taiho Pharmaceutical, and Baxter; Honoraria: Meiji Seika Pharma, Teijin Pharma, Eli Lilly Japan, MSD, AstraZeneca, AbbVie, Eisai, Ono Pharmaceutical, Yakult Honsha, Daiichi Sankyo, Chugai Pharmaceutical, Nihon Servier, and Novartis Pharma; Scientific advisory board: AstraZeneca, Nippon Shinyaku, Nihon Servier, Novartis Pharma, Pfizer, and Mundipharma. Junji Furuse is an Editorial Board Member of Liver Cancer. Norihiro Kokudo is an Associate Editor Member of Liver Cancer."

"Funding Sources This work was supported by the Japan Liver Oncology Group with funding from Bayer Yakuhin Ltd., Japan under a research contract."

"The study was conducted in accordance with the Declaration of Helsinki. The study was registered at ClinicalTrials.gov (NCT01217034) and was approved by the institutional review boards and/or independent Ethics Committees of the participating institutions. All patients provided written informed consent prior to enrolment. Conclusions: In TACTICS trial, TACE plus sorafenib did not show significant OS benefit over TACE alone; however, clinical meaningful OS prolongation and significantly improved PFS was observed. Thus, the TACE plus sorafenib can be considered a choice of treatment in intermediate-stage HCC, especially in patients with high tumor burden. Trial Registration: NCT01217034."