Comparing a PD-L1 inhibitor plus chemotherapy to chemotherapy alone in neoadjuvant therapy for locally advanced ESCC: a randomized Phase II clinical trial A randomized clinical trial of neoadjuvant therapy for ESCC

被引：28

作者：

Li, Yong ^{[1
]}

Zhou, Aiping ^{[2
]}

Liu, Shuoyan ^{[3
]}

He, Ming ^{[4
]}

Chen, Keneng ^{[5
]}

Tian, Ziqiang ^{[4
]}

Li, Yin ^{[1
]}

Qin, Jianjun ^{[1
]}

Wang, Zhen ^{[1
]}

Chen, Haiquan ^{[6
]}

Tian, Hui ^{[7
]}

Yu, Yue ^{[8
]}

Qu, Wang ^{[2
]}

Xue, Liyan ^{[9
]}

He, Shun ^{[10
]}

Wang, Shuhang ^{[8
]}

Bie, Fenglong ^{[1
]}

Bai, Guangyu ^{[1
]}

Zhou, Bolun ^{[1
]}

Yang, Zhaoyang ^{[9
]}

Huang, Huiyao ^{[8
]}

Fang, Yan ^{[11
]}

Li, Benjamin ^{[12
]}

Dai, Xiangrong ^{[12
]}

Gao, Shugeng ^{[1
]}

He, Jie ^{[1
]}

机构：

[1] Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Dept Thorac Surg, 17 Panjiayuannanli, Beijing 100021, Peoples R China

[2] Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Dept Med Oncol, Beijing 100021, Peoples R China

[3] Fujian Prov Canc Hosp, Fujian, Peoples R China

[4] Hebei Med Univ, Hosp 4, Shijiazhuang, Hebei, Peoples R China

[5] Peking Univ, Canc Hosp, Beijing, Peoples R China

[6] Fudan Univ, Canc Hosp, Shanghai, Peoples R China

[7] Shandong Univ, Qilu Hosp, Jinan, Shandong, Peoples R China

[8] Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Clin Trial Ctr, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing 100021, Peoples R China

[9] Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Dept Pathol, Beijing 100021, Peoples R China

[10] Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Dept Endoscopy, Beijing 100021, Peoples R China

[11] Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, PET CT Ctr, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing 100021, Peoples R China

[12] Lees Pharmaceut Ltd, Shenzhen, Peoples R China

来源：

BMC MEDICINE | 2023年 / 21卷 / 01期

基金：

中国国家自然科学基金;

关键词：

PD-L1; Chemotherapy; Neoadjuvant treatment; Esophageal squamous cell carcinoma (ESCC); Major pathological response (MPR); SQUAMOUS-CELL CARCINOMA; SINGLE-ARM TRIAL; OPEN-LABEL; ESOPHAGEAL; PACLITAXEL; SINTILIMAB; CHEMORADIOTHERAPY; TORIPALIMAB; MULTICENTER; CISPLATIN;

D O I：

10.1186/s12916-023-02804-y

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BackgroundA Phase II study was undertaken to evaluate the safety and efficacy of the neoadjuvant socazolimab, a novel PD-L1 inhibitor, in combination with nab-paclitaxel and cisplatin for locally advanced esophageal squamous cell carcinoma (ESCC).MethodsSixty-four patients were randomly divided between the Socazolimab + nab-paclitaxel + cisplatin (TP) arm (n = 32) and the control arm (n = 32), receiving either socazolimab (5 mg/kg intravenously (IV), day 1) or a placebo with nab-paclitaxel (125 mg/m(2) IV, day 1/8) and cisplatin (75 mg/m(2) IV, day 1) repeated every 21 days for four cycles before surgery. The primary endpoint was major pathological response (MPR), and the secondary endpoints were pathological complete response (pCR), R0 resection rate, event-free survival (EFS), overall survival (OS), and safety.ResultsA total of 29 (90.6%) patients in each arm underwent surgery, and 29 (100%) and 28 (98.6%) patients underwent R0 resection in the Socazolimab + TP and Placebo + TP arms, respectively. The MPR rates were 69.0 and 62.1% (95% Confidence Interval (CI): 49.1-84.0% vs. 42.4-78.7%, P = 0.509), and the pCR rates were 41.4 and 27.6% (95% CI: 24.1-60.9% vs. 13.5-47.5%, P = 0.311) in the Socazolimab + TP and Placebo + TP arms, respectively. Significantly higher incidence rates of ypT0 (37.9% vs. 3.5%; P = 0.001) and T downstaging were observed in the Socazolimab + TP arm than in the Placebo + TP arm. The EFS and OS outcomes were not mature.ConclusionsThe neoadjuvant socazolimab combined with chemotherapy demonstrated promising MPR and pCR rates and significant T downstaging in locally advanced ESCC without increasing surgical complication rates.

引用

页数：12

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