PO.CL07.04 · 临床研究
卡瑞利珠单抗联合化疗作为晚期食管鳞状细胞癌二线治疗的探索性研究
Exploratory study of camrelizumab combined with chemotherapy as second-line treatment for advanced esophageal squamous cell carcinoma
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
背景：晚期食管鳞状细胞癌（ESCC）患者预后不良，一线治疗失败后选择有限。本研究旨在评估卡瑞利珠单抗联合化疗作为二线治疗在既往有或无免疫治疗暴露的患者中的疗效和安全性。
方法：这项单中心、多队列、2期探索性临床试验入组了局部复发或转移性ESCC患者，这些患者对一线治疗失败或不耐受。患者被分为两个队列：既往接受过免疫治疗者（队列1）和未接受过者（队列2）。所有患者接受卡瑞利珠单抗（每3周一次，最长2年）联合以白蛋白结合型紫杉醇或氟尿嘧啶为基础的化疗（每3周一次，4-6个周期）。主要终点为无进展生存期（PFS）。
结果：2021年5月至2025年9月间，共入组40例患者，每个队列各20例。队列1的中位年龄为67岁，队列2为66岁。队列1和队列2分别有18例（90%）和15例（75%）为男性；15例（75%）和15例（75%）的ECOG体能状态为1；10%和15%有肺转移；55%和45%有淋巴结转移。根据RECIST 1.1，在队列1和队列2的15例和18例可评估患者中，客观缓解率（ORR）分别为33.3%和50.0%，疾病控制率（DCR）分别为93.3%和88.9%。中位无进展生存期（mPFS）在队列1为4.5个月（95%CI 2.13-6.8），队列2为9.5个月（95%CI 2.7-16.4）。中位总生存期（mOS）尚未达到。最常见的不良事件（AE）为淋巴细胞计数减少（90%和75%）、贫血（85%和70%）和中性粒细胞减少（50%和40%），均为1-3级。未发生4级或5级AE。最常见的免疫相关不良事件（irAE）为反应性皮肤毛细血管内皮增生（64%和57.1%），所有病例均为1-2级。
结论：卡瑞利珠单抗联合化疗作为二线治疗在晚期ESCC中显示出良好的抗肿瘤疗效和安全性，无论患者既往是否接受过免疫治疗。
查看英文原文 English abstract
Background: Patients with advanced esophageal squamous cell carcinoma (ESCC) face a poor prognosis and limited options after first-line therapy failure. This study aims to evaluate the efficacy and safety of camrelizumab combined with chemotherapy as a second-line treatment in patients who with or without prior immunotherapy exposure.
Method:This single-center, multi-cohorts, phase II exploratory clinical trial enrolled patients with locally recurrent or metastatic ESCC who had either failed or were intolerant to first-line treatment. Patients were stratified into two cohorts: those who had previously received immunotherapy (Cohort 1) and those who had not (Cohort 2). All patients received camrelizumab (Q3W, up to 2 years) combined with nab-paclitaxel or fluorouracil based chemotherapy (Q3W, 4-6 cycles).The primary endpoint was progression-free survival (PFS).
Results: Between May 2021 and September 2025, 40 patients were enrolled, with 20 patients in each cohort. The median age was 67 years in Cohort 1 and 66 years in Cohort 2.The median age was 67 years in Cohort 1 and 66 years in Cohort 2. The cohorts comprised 18 (90%) and 15(75%) males;15(75%) and 15(75%) with an ECOG performance status of 1; 10% and 15% with pulmonary metastases; and 55% and 45% with lymph node metastases, respectively. According to RECIST 1.1, among the 15 and 18 evaluable patients in Cohorts 1 and 2, the objective response rate (ORR) was 33.3% and 50.0%, and the disease control rate (DCR) was 93.3% and 88.9%, respectively. The median progression-free survival (mPFS) was 4.5 months(95%CI 2.13-6.8 ) in Cohort 1 and 9.5 months(95%CI 2.7-16.4 ) in Cohort 2. The median overall survival(mOS) was not reached.The most common adverse events (AEs) were lymphocyte count decreased (90% and 75%), anemia (85% and 70%), and decreased neutrophils (50% and 40%), which were grade 1-3. No grade 4 or 5 AEs occurred.The most common immune-related AEs (irAEs) was reactive cutaneous capillary endothelial proliferation(64.% and 57.1%), which was grade 1-2 in all cases.
Conclusion: Camrelizumab combined with chemotherapy showed good antitumor efficacy and safety in advanced ESCC as second-line treatment, regardless of whether the patients have previously received immunotherapy.
利益披露 Disclosure
L. Wang, None..
B. Fan, None..
B. Zou, None..
A. Gao, None..
S. Wang, None..
C. Wang, None..
Q. Shao, None..
Y. Yu, None..
H. Zhao, None..
J. Wang, None..
Y. Yi, None..
Q. Yu, None.