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Daniele et al. Hepatoma Res 2021;7:61  https://dx.doi.org/10.20517/2394-5079.2021.58  Page 7 of 14

                INR 1.7-2.3                                   1      (6.3%)        0       (0.0%)
                INR > 2.3                                     0      (0.0%)        1       (5.6%)
                Morphology of hepatocellular carcinoma
                Uninodular and extension ≤ 50%                2      (12.5%)       2       (11.1%)
                Multinodular and extension ≤ 50%              13     (81.3%)       13      (72.2%)
                Massive or extension > 50%                    1      (6.3%)        3       (16.7%)
                Alpha-fetoprotein
                < 400 µg/L                                    10     (62.5%)       12      (75.0%)
                ≥ 400 µg/L                                    6      (37.5%)       6       (37.5%)
                Portal vein thrombosis
                No                                            7      (43.8%)       8       (44.4%)
                Yes                                           9      (56.3%)       10      (62.5%)
                Previous therapyΔ
                Surgical resection                            2      (12.5%)       0       (0.0%)
                Percutaneous ethanol injection                2      (12.5%)       5       (31.3%)
                Radiofrequency ablation                       4      (25.0%)       6       (37.5%)
                       ⁋
                TAE/TACE                                      8      (50.0%)       4       (25.0%)
                None                                          8      (50.0%)       10      (55.6%)
               †                 ‡                     §                            |
                BSC: Best supportive care;  CLIP: cancer liver Italian program;  ECOG: Eastern Cooperative Oncology Group;  : the same patient may have more

               than  one  aetiologic  factors;  Δ:  the  same  patient  may  have  received  more  than  one  previous  treatment;  TAE/TACE :  transarterial
               embolization/transarterial chemoembolization.



































                                                      Figure 2. Study flow.

               daily rather than 800 mg. Four patients required a dose reduction during the treatment. At the time of the
               analysis, all patients had discontinued sorafenib, 11 of them after one cycle. Reasons for treatment
               discontinuation were progression of HCC (6 cases), toxicity (5 cases), patient refusal (3 cases, 2 of whom
               with diarrhea), and worsening from Child-Pugh B to C (2 cases). Adverse events leading to treatment
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