Composition of the data monitoring committee, its role, and reporting structure
Data monitoring committee (DMC) consisting of clinicians with experience to treat GC patients with PM and to conduct clinical trials will monitor the safety of the trial subjects throughout the study. Safety analyses will be held after each 13 (35%) will complete the assigned treatment. DMC members are independent of the sponsor and will provide a recommendation to stop or continue the study. The advice of the DMC will be shared with the sponsor and principal investigator of the study, who will be responsible to inform the local research ethics committee if necessary.