UNASSIGNED:术前pembrolizumab联合放化疗(PPCT)治疗可切除的食管鳞状细胞癌的安全性和可行性已被先前的术前抗PD-1抗体联合放化疗治疗局部晚期食管鳞状细胞癌(PALACE)-1试验证实。还观察到潜在的治疗益处,PPCT后病理完全缓解率为55.6%。我们将进行多中心单臂PALACE-2研究,以调查疗效并进一步确认PPCT的安全性(ClinicalTrials.govID:NCT04435197)。
未经证实:共有143名先前未经治疗的患者,本地先进,和手术可切除的食管鳞状细胞癌(T2至T4a,N0到N+,M0)将在PALACE-2中注册。主要排除标准是自身免疫性疾病,间质性肺病,正在进行的免疫抑制治疗,接受过化疗,放射治疗,靶向治疗,或其他恶性肿瘤的免疫治疗。正的程序性细胞死亡配体1表达对于登记不是强制性的。患者将接受PPCT,其中包括并发派姆单抗(第1天和第22天200mg),卡铂(曲线下面积=2,每周一次,共5周),nab-紫杉醇(50mg/m2,每周一次,共5周),和放疗(23分1.8Gy,每周5分)。食管切除术将在PPCT完成后4至6周内进行。
UNASSIGNED:主要终点是病理性完全缓解率。次要结局指标是3年无病生存率,3年总生存率,R0切除率,以及新辅助和围手术期的不良事件。
未经批准:PPCT被初步证明是安全的,可行,并通过PALACE-1试验提供潜在的治疗益处。随后的多中心PALACE-2研究将调查疗效并进一步确认PPCT对局部晚期,可切除食管鳞状细胞癌。
UNASSIGNED: The safety and feasibility of preoperative pembrolizumab combined with chemoradiotherapy (PPCT) for resectable esophageal squamous cell carcinoma have been confirmed by the prior Preoperative Anti-PD-1 Antibody combined with Chemoradiotherapy for Locally Advanced Squmous Cell Carcinoma of Esophageus (PALACE)-1 trial. Potential therapeutic benefit was also observed with a pathologic complete response rate of 55.6% after PPCT. We will conduct the multicenter single-arm PALACE-2 study to investigate the efficacy and to further confirm the safety of PPCT (ClinicalTrials.gov ID: NCT04435197).
UNASSIGNED: A total of 143 patients with previously untreated, locally advanced, and surgically resectable esophageal squamous cell carcinoma (T2 through T4a, N0 through N+, M0) will be enrolled in PALACE-2. Main exclusion criteria are autoimmune disease, interstitial lung disease, ongoing immunosuppressive therapy, and having received chemotherapy, radiotherapy, target therapy, or immune therapy for this or any other malignancies. Positive programmed cell death ligand 1 expression is not mandatory for enrollment. Patients will receive PPCT, which includes concurrent pembrolizumab (200 mg on day 1 and day 22), carboplatin (area under the curve = 2, once a week for 5 weeks), nab-paclitaxel (50 mg/m2, once a week for 5 weeks), and radiotherapy (23 fractions of 1.8 Gy, 5 fractions a week). Esophagectomy will be performed within 4 to 6 weeks after the completion of PPCT.
UNASSIGNED: The primary end point is the rate of pathologic complete response. Secondary outcome measures are 3-year disease-free survival rate, 3-year overall survival rate, R0 resection rate, and adverse events during neoadjuvant and perioperative periods.
UNASSIGNED: PPCT was preliminarily demonstrated to be safe, feasible, and to provide potential therapeutic benefits by the PALACE-1 trial. The subsequent multicenter PALACE-2 study will investigate the efficacy and further confirm the safety of PPCT for locally advanced, resectable esophageal squamous cell carcinoma.