Organ-Preserving Endoscopic Resection & Adjuvant RADIO-immuno-chemotherapy for Esophageal Cancer

"Durvalumab treatment is to begin six weeks following patient ESD/EMR surgery.~Patients may delay dosing under the following certain circumstances:~1. Dosing may be delayed per Toxicity Management Guidelines (Appendix IV), due to either an immune or a non-immune-related AE.~2. Dosing intervals of subsequent cycles may be shortened as clinically feasible in order to gradually align treatment cycles with the schedule of tumor efficacy (RECIST) and PRO assessments. Subsequent time between 2 consecutive doses cannot be less than 22 days, based on the half-lives of durvalumab (see current Investigator Brochure for durvalumab).~3. Standard of Care Arm (CROSS):~4. Patients may delay and subsequently resume dosing per local standard clinical practice.~If dosing must be delayed for reasons other than treatment-related toxicity, dosing will occur as soon as feasible."

"Durvalumab treatment is to begin six weeks following patient ESD/EMR surgery.~Patients may delay dosing under the following certain circumstances:~1. Dosing may be delayed per Toxicity Management Guidelines (Appendix IV), due to either an immune or a non-immune-related AE.~2. Dosing intervals of subsequent cycles may be shortened as clinically feasible in order to gradually align treatment cycles with the schedule of tumor efficacy (RECIST) and PRO assessments. Subsequent time between 2 consecutive doses cannot be less than 22 days, based on the half-lives of durvalumab (see current Investigator Brochure for durvalumab).~3. Standard of Care Arm (CROSS):~4. Patients may delay and subsequently resume dosing per local standard clinical practice.~If dosing must be delayed for reasons other than treatment-related toxicity, dosing will occur as soon as feasible."