Endpoints
PD, tumor
ADVERSE REACTIONS, TUMOR, ADVERSE EVENTS, DISEASE, TRANSMISSION, SECONDARY
The primary endpoint is Objective Response Rate. The secondary endpoints are progression-free survival, disease control rate, safety, duration of response, overall survival, quality of life. The safety endpoints are occurrence of adverse events, proportion of patients withdrawn due to adverse events, proportion of patients with dose adjustment due to adverse events. We will closely evaluate and monitor safety information in accordance with safety information evaluation and management practices during drug clinical trials. We will timely submit suspected and unexpected serious adverse reactions (SUSAR) reports through the pharmacovigilatory Electronic Transmission System (PV system), and timely submit safety update reports (DSUR) during the study and other potential serious safety risk information reports through the Drug Approval Center website. We will carry out risk monitoring, identification, assessment and control of safety information, timely discover existing safety problems or other risks, and promptly take measures of risk control and risk minimization, including general risk management measures (such as modifying clinical trial protocol), active suspension or termination of clinical trials.Efficacy evaluation will be performed every two cycles (i.e., every 6 weeks) from 24 weeks after the first dose. All imaging data will be kept for patients with CR, PR, SD, and PD. If subjects discontinue the trial before the development of PD, follow up every 6 weeks for imaging (external hospital reports are acceptable) to observe whether the tumor progresses or take other anti-tumor therapies. Telephone or clinical follow-ups are acceptable.