Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer.
HB≥90g/L；
ANC≥1.5×109/L；
PLT≥100×109/L；
ALT and AST<2.5ULN（liver metastasis: ALT and AST<5ULN）；
Patients initially diagnosed as unresectable (e.g. large metastatic lymph nodes) and treated with conversion therapy;
Patients with severe postoperative complications who are not suitable for adjuvant therapy;
Patients who have received any form of adjuvant therapy after surgery;
Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;
Parallel
Adebrelizumab
DrugPatients undergoing radical surgery to achieve R0 resection were randomised in a 1:1 ratio at 4-16 weeks postoperatively, with patients in the trial group receiving adjuvant treatment with adebrelizumab (up to 17 cycles)
DFS
DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
OS
Baseline to measured date of death from any cause
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Through continuous monitoring and analysis of the safety data, the drug safety characteristics were evaluated, the suspected and unexpected serious adverse reactions and other major risks were identified in time, and appropriate measures were taken to fully control the risks and protect the safety of the subjects.
Patient reported outcome (Quality of Life questionnaire of cancer patients)
EORTC Quality of Life-Core 30/18 questionnaire module
Click on the lead sponsor to view all of their trials.
