Precision palliative care in advanced/recurrent esophageal cancer patients treated with anti-PD-1/PD-L1 immunotherapy (ESO-Shanghai 25): a randomized, phase III Trial

Over half of patients with advanced or recurrent esophageal cancer experience malnutrition, psychological distress, and cancer-related pain, which impair immune function, diminish quality of life, and attenuate responses to immunotherapy. Whether a precision palliative care (PC) model that integrates nutritional, psychological, and symptomatic support can improve survival and quality of life in these patients undergoing anti-PD-1/PD-L1 immunotherapy remains unknown. We are conducting a multicenter randomized trial to evaluate the superiority of a precision PC model compared with standard oncology care in improving patients' overall survival (OS). All patients will be randomly assigned to either the Standard Arm (standard oncology care)or the Precision Arm (standard oncology care + precision PC). Patients in the Standard Arm receive anti-PD-1/PD-L1 immunotherapy-based standard oncology care. Patients assigned to the Precision Arm receive anti-PD-1/PD-L1 immunotherapy-based standard oncologic care and precision PC, in which patients meeting any of the following criteria are stepped up to meet with the precision PC clinicians every 4 weeks: (1) malnutrition (NRS2002 ≥ 3 or meeting GLIM criteria), (2) psychological distress (GAD-7 ≥ 5 or PHQ-9 ≥ 5), or (3) moderate-to-severe symptoms (any MDASI symptom score ≥4). The primary endpoint is overall survival (OS). The secondary endpoints are quality of life and progression-free survival (PFS).Clinical trial registration: NCT06787313 (clinicaltrials.gov).