| Number of patients screened |
17 |
| Number of patients enrolled |
17 |
| Number of patients evaluable for toxicity |
17 |
| Number of patients evaluated for efficacy |
16 |
| Evaluation method |
RECIST 1.1 |
| Response assessment, PR |
1 (6.3%) |
| Response assessment, SD |
9 (56.3%) |
| Response assessment, PD |
6 (37.5%) |
| (Median) duration assessments, OS |
15.3 months (95% CI, 3.1-not reached) |
| (Median) duration assessments, PFS |
3.2 months (95% CI, 1.2-7.4 |
| (Median) duration assessments, TTF |
3.2 months (95% CI, 1.2-not reached) |
| Outcome notes |
The 1-year survival rate (the primary endpoint of this study) was 53.3% (95% CI, 25.9-74.6) (Table 1). The ORR and disease control rate were 6.3% (95% CI, 0.2-30.2) and 62.5% (95% CI, 35.4-84.8), respectively. |