BACKGROUND: Blocking the interaction between PD-1 and its ligands is a promising 
treatment strategy for advanced hepatocellular carcinoma. This study aimed to 
assess the antitumour activity and safety of the anti-PD-1 inhibitor 
camrelizumab in pretreated patients with advanced hepatocellular carcinoma.
METHODS: This is a multicentre, open-label, parallel-group, randomised, phase 2 
trial done at 13 study sites in China. Eligible patients were aged 18 years and 
older with a histological or cytological diagnosis of advanced hepatocellular 
carcinoma, had progressed on or were intolerant to previous systemic treatment, 
and had an Eastern Cooperative Oncology Group performance score of 0-1. Patients 
were randomly assigned (1:1) to receive camrelizumab 3 mg/kg intravenously every 
2 or 3 weeks, via a centralised interactive web-response system using block 
randomisation (block size of four). The primary endpoints were objective 
response (per blinded independent central review) and 6-month overall survival, 
in all randomly assigned patients who had at least one dose of study treatment. 
Safety was analysed in all treated patients. This study is registered with 
ClinicalTrials.gov, number NCT02989922, and follow-up is ongoing, but enrolment 
is closed.
FINDINGS: Between Nov 15, 2016, and Nov 16, 2017, 303 patients were screened for 
eligibility, of whom 220 eligible patients were randomly assigned and among whom 
217 received camrelizumab (109 patients were given treatment every 2 weeks and 
108 every 3 weeks). Median follow-up was 12·5 months (IQR 5·7-15·5). Objective 
response was reported in 32 (14·7%; 95% CI 10·3-20·2) of 217 patients. The 
overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)]. Grade 3 
or 4 treatment-related adverse events occurred in 47 (22%) of 217 patients; the 
most common were increased aspartate aminotransferase (ten [5%]) and decreased 
neutrophil count (seven [3%]). Two deaths were judged by the investigators to be 
potentially treatment-related (one due to liver dysfunction and one due to 
multiple organ failure).
INTERPRETATION: Camrelizumab showed antitumour activity in pretreated Chinese 
patients with advanced hepatocellular carcinoma, with manageable toxicities, and 
might represent a new treatment option for these patients.
FUNDING: Jiangsu Hengrui Medicine.