Table 2.
Study flow chart and visit schedule.
| FLOW CHART | Screening | Treatment visit | End of treatment visit |
Safety follow-up visit |
|---|---|---|---|---|
| Timepoint | -d14–d0 | Before dosing every cycle | Within 7 days after termination of treatment | Within 30 days after the last dose |
| Informed consent | X | |||
| Inclusion and Exclusion criteria | X | |||
| Demographic characteristics | X | |||
| Medical history and treatment history | X | |||
| Physical examination | X | X | X | X |
| ECOG score | X | X | X | X |
| QLQ-C30 score | X | X | X | X |
| Vital sign | X | X | X | X |
| Tumor tissue sample | X | |||
| Virus detection:HbsAg,HbsAb,HbcAb,HCVAb,HIVAb | X | |||
| Complete blood count, Urine Routine Examination | X | X | X | X |
| Alanine aminotransferase, Aspartate aminotransferase, Direct bilirubin, Total bilirubin, Glucose, Potassium,Sodium,Calcium, Phosphorus, blood urea nitrogen,Creatinine,Creatinine clearance, Total cholesterol |
X | X | X | X |
| Activeated partial thromboplastin time, Prothrombin time, Thrombin time,International Normalized Ratio | X | X | X | X |
| Pregnacy test | X | X | ||
| Free triiodothyronine, Free thyroxine, Thyroid-stimulating hormone | X | X | X | X |
| Cortisol, Adrenocorticotropic hormone | X | X | X | X |
| 12-lead electrocardiogram | X | X | X | X |
| Echocardiography | X | |||
| Lung function | X | Once every 3 months | X | |
| Evaluation of COPD symptoms | X | Once every 3 months | X | |
| Risk assessment of COPD exacerbations | X | Once every 3 months | X | |
| Evaluation of severity of acute exacerbation of COPD | X | Once every 3 months | X | |
| Drug administration | X | |||
| Chest and abdominal CT (or abdominal and adrenal ultrasound), Cranial enhanced MRI,Neck ultrasound, Bone ECT, PET-CT | X | X | ||
| Adverse events and drug combinations | X | X | ||
| Survival follow-up | X | |||