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The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.

Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial

Open access
Luo, Huiyan, Lu, Jin, Bai, Yuxian, Mao, Teng, Wang, Jun, Fan, Qingxia, Zhang, Yiping, Zhao, Kuaile, Chen, Zhendong, Gao, Shegan, Li, Jiancheng, Fu, Zhichao, Gu, Kangsheng, Liu, Zhihua, Wu, Lin, Zhang, Xiaodong, Feng, Jifeng, Niu, Zuoxing, Ba, Yi, Zhang, Helong, Liu, Ying, Zhang, Li, Min, Xuhong, Huang, Jing, Cheng, Ying, Wang, Dong, Shen, Yu, Yang, Qing, Zou, Jianjun, Xu, Rui-Hua, ESCORT-1st Investigators, Yuan, Xianglin, Ma, Dong, Liu, Li, Ye, Feng, Liu, Tianshu, Wang, Xiuwen, Liu, Likun, Xia, Bing, Ran, Fengming, Sun, Sanyuan, Miao, Zhanhui, Bie, Jun, Gao, Yong, Yu, Junyan, Chen, Li, He, Yifu, Ren, Wei, Luo, Suxia, Zhao, Guangqiang, Lin, Youen, Chen, Long, Guo, Zhiyuan, Hu, Chunhong, Wang, Ying, Xu, Nong, Chen, Baofu, Zhan, Xianbao, Chen, Yuping, Lu, Hongda, Qin, Shukui, Wang, Guolei, Chen, Liming, Bai, Li, Zhang, Jingdong·2021·JAMA
DOI 10.1001/jama.2021.12836
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Abstract

Importance: Standard first-line therapy for advanced or metastatic esophageal carcinoma is chemotherapy, but the prognosis remains poor. Camrelizumab (an anti-programmed death receptor 1 [PD-1] antibody) showed antitumor activity in previously treated advanced or metastatic esophageal squamous cell carcinoma. Objective: To evaluate the efficacy and adverse events of camrelizumab plus chemotherapy vs placebo plus chemotherapy as a first-line treatment in advanced or metastatic esophageal squamous cell carcinoma. Design, Setting, and Participants: This randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) enrolled patients from 60 hospitals in China between December 3, 2018, and May 12, 2020 (final follow-up, October 30, 2020). A total of 751 patients were screened and 596 eligible patients with untreated advanced or metastatic esophageal squamous cell carcinoma were randomized. Interventions: Patients were randomized 1:1 to receive either camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with up to 6 cycles of paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). All treatments were given intravenously every 3 weeks. Main Outcomes and Measures: Coprimary end points were overall survival (significance threshold, 1-sided P < .02) and progression-free survival (significance threshold, 1-sided P < .005). Results: Of the 596 patients randomized (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.8%]), 1 patient in the placebo-chemotherapy group did not receive planned treatment. A total of 490 patients (82.2%) had discontinued the study treatment. The median follow-up was 10.8 months. The overall survival for the camrelizumab-chemotherapy group was a median of 15.3 months (95% CI, 12.8-17.3; 135 deaths) vs a median of 12.0 months (95% CI, 11.0-13.3; 174 deaths) for the placebo-chemotherapy group (hazard ratio [HR] for death, 0.70 [95% CI, 0.56-0.88]; 1-sided P = .001). Progression-free survival for camrelizumab plus chemotherapy was a median of 6.9 months (95% CI, 5.8-7.4; 199 progression or deaths) vs 5.6 months (95% CI, 5.5-5.7; 229 progression or deaths) for the placebo-chemotherapy group (HR for progression or death, 0.56 [95% CI, 0.46-0.68]; 1-sided P < .001). Treatment-related adverse events of grade 3 or higher occurred in 189 patients (63.4%) in the camrelizumab-chemotherapy group and 201 (67.7%) in the placebo-chemotherapy group, including treatment-related deaths among 9 patients (3.0%) and 11 patients (3.7%), respectively. Conclusions and Relevance: Among patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of camrelizumab to chemotherapy, compared with placebo and chemotherapy, significantly improved overall survival and progression-free survival. Trial Registration: ClinicalTrials.gov Identifier: NCT03691090.

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Metadata

Authors
Luo, H., Lu, J., Bai, Y., Mao, T., Wang, J., Fan, Q., Zhang, Y., Zhao, K., Chen, Z., Gao, S., Li, J., Fu, Z., Gu, K., Liu, Z., Wu, L., Zhang, X., Feng, J., Niu, Z., Ba, Y., Zhang, H., Liu, Y., Zhang, L., Min, X., Huang, J., Cheng, Y., Wang, D., Shen, Y., Yang, Q., Zou, J., Xu, R.-H., ESCORT-1st Investigators, Yuan, X., Ma, D., Liu, L., Ye, F., Liu, T., Wang, X., Liu, L., Xia, B., Ran, F., Sun, S., Miao, Z., Bie, J., Gao, Y., Yu, J., Chen, L., He, Y., Ren, W., Luo, S., Zhao, G., Lin, Y., Chen, L., Guo, Z., Hu, C., Wang, Y., Xu, N., Chen, B., Zhan, X., Chen, Y., Lu, H., Qin, S., Wang, G., Chen, L., Bai, L., & Zhang, J.
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2021-09-14
Volume
326
Issue
10
Pages
916
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.2021.12836
OpenAlex
W3200109370
Cited by
803
References
20
FWCI
104.86
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. https://app.cochat.ai/papers/10.1001/jama.2021.12836
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Luo, H., Lu, J., Bai, Y., Mao, T., Wang, J., Fan, Q., Zhang, Y., Zhao, K., Chen, Z., Gao, S., Li, J., Fu, Z., Gu, K., Liu, Z., Wu, L., Zhang, X., Feng, J., Niu, Z., Ba, Y., . . . Zhang, J. (2021). Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. https://doi.org/10.1001/jama.2021.12836

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