Dose reductions
| Number (%) or time (day) | |
| Treatment permanently interrupted because of toxic effects | 4/43 (9.3%) |
| Treatment dose reduced/temporarily interrupted | 24/43 (55.8%) |
| Treatment temporarily interrupted | 6/43 (14.0%) |
| Treatment dose reduced | 21/43 (48.8%) |
| Dose of apatinib +camrelizumab | |
| 500 mg daily +200 mg Q2W initially | 43/43 (100.0%) |
| 250 mg daily +200 mg Q2W (−1 dose level) | 21/43 (48.8%) |
| 125 mg daily +200 mg Q2W (−2 dose level) | 1/43 (2.3%) |
| Days apatinib held for one interruption | |
| Mean (SD) | 9.0 (10.2) |
| Median (IQR) | 3.0 (2.0–15.0) |
| Days apatinib held during trial | |
| Mean (SD) | 18.0 (14.2) |
| Median (IQR) | 15.0 (3.0–31.5) |
| Days camrelizumab held for one interruption | |
| Mean (SD) | 12.7 (7.3) |
| Median (IQR) | 11.0 (7.0–17.1) |
| Days camrelizumab held during trial* | |
| Mean (SD) | 12.7 (7.3) |
| Median (IQR) | 11.0 (7.0–17.1) |
Data are n (%), mean (SD), or median (IQR). Camrelizumab was temporary interrupted mainly because of immune-related toxicities judged by investigators. Temporary interruptions of both drugs were usually for several causes: wound dehiscence, diarrhea, blood bilirubin increased and aminotransferase increased and pneumothorax. Of the 43 patients, 21 patients who had reduced apatinib doses to 250 mg were also treated at a dose level of 200 mg Q2W of camrelizumab (−1 dose level). Thrombocytopenia, hand and foot syndrome, oral mucositis or other skin toxic effects, hypertension, and diarrhea were the most common causes for apatinib dose reductions.
*Throughout the trial, camrelizumab had only been held for temporary interruptions for once in all four patients.