Number of Patients Screened	42
Number of Patients Enrolled	40
Number of Patients Evaluable for Toxicity	35
Number of Patients Evaluated for Efficacy	37
Evaluation Method	RECIST 1.1
Response Assessment CR	n = 0 (0%)
Response Assessment PR	n = 3 (7.5%)
Response Assessment SD	n = 23 (57.5%)
Response Assessment PD	n = 11 (27.5%)
Response Assessment OTHER	n = 3 (7.5%)
(Median) Duration Assessments PFS	3.8 months; 95% CI, 2.2–5.4
(Median) Duration Assessments OS	5.8 months; 95% CI, 3.2–8.4
Outcome Notes
Only one patient is still alive. Two patients terminated apatinib because of adverse effects, and we subsequently lost touch with them. The main causes of treatment failure were disease progression and severe adverse events (AEs). We achieved our primary endpoint of 37 respondents among the 40 patients. Among them, 3 patients with PR and 23 patients with SD were observed for ORR of 7.5% and DCR of 65.0%. Five percent (2/40) of patients had obvious tumor necrosis and cavitation of lung metastasis (Fig. 1). When the responses were evaluated by mRECIST, they were PRs, and the ORR was 12.5% (5/40; Fig. 2B). Median PFS was 3.8 months (95% CI, 2.2–5.4; Fig. 3A), whereas median OS was 5.8 months (95% CI, 3.2–8.4; Fig. 3B). PFS at 2 months was 60.4%, and 3‐month PFS was 57.7%. OS at 6 months was 45.0%, and 12‐month OS was 15.9%. Two cases of massive fatal bronchopulmonary hemorrhage and one case of esophageal fistula occurred in patients with uncontrolled primary tumors (3/5, 60%). We conducted an analysis excluding the patients with uncontrolled primary tumors. This subset analysis suggested that the ORR and DCR were 8.6% (3/35) and 68.6% (24/35), mPFS2 was 3.9 months (95% CI, 3.3–4.5; Fig. 3C), and mOS2 was 6.0 months (95% CI, 3.3–8.7; Fig. 3D). PFS2 was 64.5% at 2 months and 61.4% at 3 months. Six‐month OS2 was 47.2%, and 12‐month OS2 was 14.8%.