PMID- 33282388
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220418
IS  - 2072-1439 (Print)
IS  - 2077-6624 (Electronic)
IS  - 2072-1439 (Linking)
VI  - 12
IP  - 11
DP  - 2020 Nov
TI  - A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in 
      locally advanced esophageal squamous cell carcinoma.
PG  - 6861-6867
LID - 10.21037/jtd-20-2198 [doi]
AB  - BACKGROUND: Esophageal squamous cell carcinoma (ESCC) remains a challenging 
      malignancy with poor prognosis and limited therapeutic methods. However, recent 
      clinical trials of immune checkpoint inhibitors (ICIs) have shown promising 
      results in the treatment of lethal malignancies. The second-line treatment of 
      late-stage ESCC was approved based on the results of KEYNOTE-180, KEYNOTE-181 and 
      ATTRACTION-1, ATTRACTION-3. Combining ICIs with chemotherapy in neoadjuvant 
      therapy may benefit patients with locally advanced, resectable ESCC. METHODS: A 
      two-arm phase II trial was launched in July 2019 in Henan Cancer Hospital. The 
      primary outcome measure will be completed within 21 months. The pathological 
      complete response (pCR) rate is the primary endpoint, and the secondary endpoints 
      include overall survival (OS), disease-free survival (DFS), the toxicities of the 
      neoadjuvant toripalimab plus chemotherapy, the relationship between combined 
      positivity score (CPS) of specimen and the treatment response, the relationship 
      between lymphocyte infiltration and the treatment response, the progression-free 
      survival (PFS) rate, and adverse events (AEs). It was assumed that the pCR rate 
      of this trial might be 25%. Therefore, the 30 enrolled patients could reject the 
      hypothesis at 75% (alpha=0.1). DISCUSSION: The study will determine the safety and 
      efficacy of neoadjuvant immunochemotherapy for ESCC and provide enough evidence 
      for phase III clinical trials. TRIAL REGISTRATION: Clinical Trials.gov, 
      NCT03985670, Registered: October 24, 2019, 
      https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0008Z9D&selectaction=Edit&uid=U0002MIY&ts=2&cx=-i71o4q. 
      Registry name: "Teripalimab Plus Chemotherapy in Local Advanced Esophageal 
      Cancer".
CI  - 2020 Journal of Thoracic Disease. All rights reserved.
FAU - Xing, Wenqun
AU  - Xing W
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Zhao, Lingdi
AU  - Zhao L
AD  - Department of Immunotherapy, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Fu, Xiaomin
AU  - Fu X
AD  - Department of Immunotherapy, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Liang, Guanghui
AU  - Liang G
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Zhang, Yong
AU  - Zhang Y
AD  - Department of Immunotherapy, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Yuan, Dongfeng
AU  - Yuan D
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Li, Zhenxuan
AU  - Li Z
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Gao, Quanli
AU  - Gao Q
AD  - Department of Immunotherapy, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Zheng, Yan
AU  - Zheng Y
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
CN  - written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG)
LA  - eng
SI  - ClinicalTrials.gov/NCT03985670
PT  - Journal Article
PL  - China
TA  - J Thorac Dis
JT  - Journal of thoracic disease
JID - 101533916
PMC - PMC7711391
OTO - NOTNLM
OT  - Esophageal cancer
OT  - clinical trial
OT  - neoadjuvant immunochemotherapy
OT  - phase II
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at http://dx.doi.org/10.21037/jtd-20-2198). The authors have no 
      conflicts of interest to declare.
EDAT- 2020/12/08 06:00
MHDA- 2020/12/08 06:01
PMCR- 2020/11/01
CRDT- 2020/12/07 05:33
PHST- 2020/12/07 05:33 [entrez]
PHST- 2020/12/08 06:00 [pubmed]
PHST- 2020/12/08 06:01 [medline]
PHST- 2020/11/01 00:00 [pmc-release]
AID - jtd-12-11-6861 [pii]
AID - 10.21037/jtd-20-2198 [doi]
PST - ppublish
SO  - J Thorac Dis. 2020 Nov;12(11):6861-6867. doi: 10.21037/jtd-20-2198.