Perioperative tislelizumab plus chemotherapy for locally advanced resectable thoracic oesophageal squamous cell carcinoma trail: A prospective single-arm, phase II study (PILOT trial)

Abstract

Abstract Background The promising therapeutic outcomes of neoadjuvant immunotherapy combined with chemotherapy in the treatment of locally advanced esophageal squamous cell carcinoma (ESCC) have been confirmed by several phase Ⅱ clinical trials and have been widely used in clinical work. Theoretically, postoperative adjuvant immunotherapy may further improve the therapeutic effect, but there is still lack of evidence. The aim of this study was to analyze the safety and efficacy of perioperative immunotherapy (tislelizumab) for locally advanced resectable thoracic ESCC (PILOT trial). Methods Seventy-three eligible patients with pathologically confirmed thoracic ESCC at clinical T1b-3N1-3M0 or T3N0M0 staging will be allocated to receive neoadjuvant immunotherapy (tislelizumab 200mg d1, q3w × 2 cycles) plus chemotherapy (nad-paclitaxel 260 mg/m2 d1 + carboplatin AUC = 5 d1, q3w × 2 cycles) treatment. Patients with pathologic complete response (pCR) after esophagectomy received adjuvant tislelizumab (200 mg every 3 weeks up to one year), and patients with non-pCR were assigned adjuvant tislelizumab plus chemotherapy for two cycles and then maintenance tislelizumab (200 mg every 3 weeks up to 15 cycles). The primary endpoint of this study is 2-year disease-free survival (DFS) in non-pCR patients. The secondary endpoints include pCR rate, major pathological response rate, 2-year DFS in pCR patients, R0 resection rate, adverse events, and overall survival. Discussion This protocol has been reviewed and approved by the Ethics Committee of Shanghai Chest Hospital (IS23059). This is the first prospective clinical trial to investigate the safety and efficacy of perioperative immunotherapy for locally advanced resectable thoracic ESCC. We hypothesize that perioperative immunotherapy could be a promising therapeutic strategy which can provide better 2-year DFS in non-pCR patients. Trial registration ClinicalTrial.gov: NCT0605633