Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial.

"Conflict of Interest Statement Zhenggang Ren reports consulting support from AstraZeneca, F. Hoffmann-La Roche Ltd., and Merck. Michel Ducreux reports research support to the institution from F. Hoffmann-La Roche, Ltd., Merck, Keocyt, and Bayer and receives consulting support from AMGEN, F. Hoffmann-La Roche Ltd., Ipsen, Merck, MSD, Bayer, BeiGene, Ltd., Hutchinson, AstraZeneca, Eli Lilly, Keocyt, and Celgene. Ghassan K. Abou-Alfa reports research support to the institution from Arcus, Agios, AstraZeneca, Bayer, BioNTech, BMS, Celgene, Flatiron, Genentech/Ltd./F. Hoffmann-La Roche Ltd., Genoscience, Incyte, Polaris, Puma, QED, Sillajen, and Yiviva and receives consulting support from Agios, Alnylam, AstraZeneca, Autem, Bayer, BeiGene, Ltd., Berry Genomics, Eisai, Eli Lilly, Exelixis, Flatiron, Genentech Ltd./F. Hoffmann-La Roche Ltd., Genoscience, Helio, Incyte, Ipsen, Legend Biotech, Merck, MINA, QED, Redhill, Sillajen, Surface Oncology, Therabionics, Twoxar, Vector, and Yiviva. Philippe Merle reports grants from Ipsen and Genosciences and receives advisory board fees from F. Hoffmann-La Roche Ltd., BMS, AstraZeneca, Bayer, Eisai, MSD, Ipsen, Lilly, and Genosciences. Weijia Fang, Zhiwei Li, Julien Edeline, Lihua Wu, Sheng Hu, Tao Zhang, Jean-Frédéric Blanc, Hongming Pan, Chia-Jui Yen, Albert Tran, Guoliang Shao, Mohamed Bouattour, Yajin Chen, Jinlin Hou, Yuxian Bai, Ming-Mo Hou, and Zhiqiang Meng declare no competing interests. Eric Assenat reports research support to the institution from F. Hoffmann-La Roche Ltd. and Bayer and receives consulting support from AMGEN, F. Hoffmann-La Roche Ltd., Ipsen, Bayer, AstraZeneca, and Boston. Lorenza Rimassa reports receiving consulting support from Amgen, ArQule, AstraZeneca, Basilea, Bayer, BMS, Celgene, Eisai, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Lilly, MSD, Nerviano Medical Sciences, F. Hoffmann-La Roche Ltd., Sanofi, Servier, Taiho Oncology, and Zymeworks; lecture fees from AbbVie, Amgen, Bayer, Eisai, Gilead, Incyte, Ipsen, Lilly, Merck Serono, F. Hoffmann-La Roche Ltd., and Sanofi; travel expenses from AstraZeneca; and institutional research funding from Agios, ARMO BioSciences, AstraZeneca, BeiGene, Ltd., Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, F. Hoffmann-La Roche Ltd., and Zymeworks. Paul Ross reports grants from Bayer and Sanofi. Tim Meyer is supported by the NIHR ULCH Biomedical Research Centre. David Tougeron reports receiving consulting support from Amgen, AstraZeneca, Bayer, BMS, Ipsen, MSD, Sanofi, Servier, and Merck Serono and institutional research funding from AstraZeneca, MSD, F. Hoffmann-La Roche Ltd., and Ipsen. John Wu reports employment with BeiGene, Ltd. Vincent Li reports employment and stocks with BeiGene, Ltd. Sandra Chica-Duque reports employment with BeiGene, Ltd., and her immediate family member reports a relationship with Turning Point Therapeutics. Ann-Lii Cheng reports and receives consulting support from Bristol Myers Squibb, Bayer, Eisai, Ono Pharmaceutical, AstraZeneca, Genentech Ltd./F. Hoffmann-La Roche Ltd., MSD, BeiGene, Ltd., Exelixis Ltd., Ipsen Innovation, and F. Hoffmann-La Roche Ltd."

"The study was sponsored by BeiGene, Ltd."

"The Kaplan-Meier method was used to estimate time-to-event variables and corresponding quantiles in the responders. Two-sided CIs of DoR, PFS, and OS were calculated using the Brookmeyer and Crowley method. Two-sided CIs of DCR and CBR were calculated using a binomial exact method. Follow-up duration was calculated by the reverse Kaplan-Meier method. Patients who were lost to follow-up were censored at the last date they were known to be alive, and patients who remained alive were censored at the date of last adequate radiologic assessment or date of the first treatment dose if they had no baseline tumor assessment. Safety data were analyzed using descriptive statistics. All calculations and analyses were conducted using SAS version 9.4. This trial is registered on ClinicalTrials.gov (NCT03419897) and ChinaDrugTrials.org.cn (CTR20171257). Full statistical methods are provided in the online supplementary methods."