Study design and interventions
toxicity
DISEASE PROGRESSION, DISEASE
NATION-1907, a single-center, nonrandomized, phase 1b study, enrolled 30 patients with resectable ESCC from Zhongshan Hospital, Fudan University, between 26 December 2019 and 29 August 2020. Patients received adebrelimab (administered intravenously at a dose of 20 mg per kg body weight every three weeks) on day 1 of a planned 21-day cycle, and two doses before surgery. The study was approved by the Research Ethics Committee of Zhongshan Hospital and carried out in accordance with The International Conference on Harmonization Good Clinical Practice Guidelines, the principles of the Declaration of Helsinki, and national or local laws or regulations. Written informed consent was signed by all patients during enrollment.Neoadjuvant adebrelimab was discontinued if one of the following occurred: informed consent was withdrawn because of a patient’s personal decision, or there was unacceptable toxicity, disease progression according to RECIST 1.1 criteria, or a patient had a life-threatening disease or condition preventing further treatment. Safety and efficacy data were reviewed by an independent data-monitoring committee. There was no bias toward age, gender or race in this clinical trial. The trial was open to men and women who met the inclusion and exclusion criteria outlined. The drug (adebrelimab) and medical examination were provided free to patients, but there was no additional participant compensation.