PMID- 33553366
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220420
IS  - 2305-5839 (Print)
IS  - 2305-5847 (Electronic)
IS  - 2305-5839 (Linking)
VI  - 9
IP  - 1
DP  - 2021 Jan
TI  - A phase III study on neoadjuvant chemotherapy versus neoadjuvant toripalimab plus 
      chemotherapy for locally advanced esophageal squamous cell carcinoma: Henan 
      Cancer Hospital Thoracic Oncology Group 1909 (HCHTOG1909).
PG  - 73
LID - 10.21037/atm-20-5404 [doi]
LID - 73
AB  - BACKGROUND: Neoadjuvant chemotherapy (NAC) and neoadjuvant chemoradiotherapy 
      (NACR) are the standard treatments for esophageal squamous cell carcinoma (ESCC). 
      However, the 5-year overall survival (OS) rate is still far from satisfactory. In 
      recent years, immune checkpoint inhibitors (ICIs) have shown promising results in 
      the treatment of ESCC. More than 20 phase II clinical trials have been launched 
      to explore combinations of ICIs in the neoadjuvant setting for ESCC. Based on our 
      phase II clinical trial, a two-arm phase III trial was launched in Henan Cancer 
      Hospital. ICIs combined with NAC may usher in a new era and may benefit locally 
      advanced, resectable ESCC patients. METHODS: A two-arm phase III trial was 
      launched in April 2020 in Henan Cancer Hospital. Patient recruitment will be 
      completed within 18 months. The primary endpoint is event-free survival (EFS). 
      The secondary endpoints include pathologic complete response (pCR), disease-free 
      survival (DFS) rate, overall response rate (ORR), R0 resection rate, major 
      pathologic response (MPR), adverse events (AEs), complication rate and quality of 
      life (QOL). A biobank of pretreatment, resected tumor tissue and paired blood 
      samples will be built for translational research in the future. DISCUSSION: This 
      RCT directly compares NAC with neoadjuvant toripalimab plus chemotherapy in terms 
      of EFS for locally advanced ESCC. The results may usher in a new era of 
      resectable ESCC treatment. TRIAL REGISTRATION: NCT04280822 
      (https://www.clinicaltrials.gov/ct2/show/NCT04280822). Registered title: "A Phase 
      III, Randomized Controlled Study of Neo-adjuvant Toripalimab (JS001) in 
      Combination with Chemotherapy versus Neo-adjuvant Chemotherapy for Resectable 
      Esophageal Squamous Cell Carcinoma". Version 1.0/Nov. 21, 2019.
CI  - 2021 Annals of Translational Medicine. All rights reserved.
FAU - Zheng, Yan
AU  - Zheng Y
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Liu, Xian-Ben
AU  - Liu XB
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Sun, Hai-Bo
AU  - Sun HB
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Xu, Jinliang
AU  - Xu J
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Shen, Sining
AU  - Shen S
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Ba, Yu-Feng
AU  - Ba YF
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Yan, Ming
AU  - Yan M
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Qin, Zimin
AU  - Qin Z
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Liu, Bao-Xing
AU  - Liu BX
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Wang, Zong-Fei
AU  - Wang ZF
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Liu, Shi-Lei
AU  - Liu SL
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Zhang, Rui-Xiang
AU  - Zhang RX
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Chen, Pei-Nan
AU  - Chen PN
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Liang, Guang-Hui
AU  - Liang GH
AD  - Department of Thoracic Surgery, 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, Zhen-Xuan
AU  - Li ZX
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Liu, Qi
AU  - Liu Q
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Wang, Hao-Ran
AU  - Wang HR
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Li, Hao-Miao
AU  - Li HM
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Lv, Hongwei
AU  - Lv H
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Ma, Xiaochao
AU  - Ma X
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Zhu, Jianping
AU  - Zhu J
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Yu, Yong-Kui
AU  - Yu YK
AD  - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, China.
FAU - Xing, Wen-Qun
AU  - Xing WQ
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/NCT04280822
PT  - Journal Article
PL  - China
TA  - Ann Transl Med
JT  - Annals of translational medicine
JID - 101617978
PMC - PMC7859818
OTO - NOTNLM
OT  - Esophageal cancer (EC)
OT  - clinical trial
OT  - neoadjuvant immunochemotherapy
OT  - phase III
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at http://dx.doi.org/10.21037/atm-20-5404). The authors have no 
      conflicts of interest to declare.
EDAT- 2021/02/09 06:00
MHDA- 2021/02/09 06:01
PMCR- 2021/01/01
CRDT- 2021/02/08 05:48
PHST- 2021/02/08 05:48 [entrez]
PHST- 2021/02/09 06:00 [pubmed]
PHST- 2021/02/09 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - atm-09-01-73 [pii]
AID - 10.21037/atm-20-5404 [doi]
PST - ppublish
SO  - Ann Transl Med. 2021 Jan;9(1):73. doi: 10.21037/atm-20-5404.