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)

Yan Zheng, Xian-Ben Liu, Hai-Bo Sun, Jinliang Xu, Sining Shen, Yu-Feng Ba, Ming Yan, Zimin Qin, Bao-Xing Liu, Zong-Fei Wang, Shi-Lei Liu, Rui-Xiang Zhang, Pei-Nan Chen, Guang-Hui Liang, Dongfeng Yuan, Zhen-Xuan Li, Qi Liu, Hao-Ran Wang, Hao-Miao Li, Hongwei Lv, Xiaochao Ma, Jianping Zhu, Yong-Kui Yu, Wen-Qun Xing, written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG), Yan Zheng, Xian-Ben Liu, Hai-Bo Sun, Jinliang Xu, Sining Shen, Yu-Feng Ba, Ming Yan, Zimin Qin, Bao-Xing Liu, Zong-Fei Wang, Shi-Lei Liu, Rui-Xiang Zhang, Pei-Nan Chen, Guang-Hui Liang, Dongfeng Yuan, Zhen-Xuan Li, Qi Liu, Hao-Ran Wang, Hao-Miao Li, Hongwei Lv, Xiaochao Ma, Jianping Zhu, Yong-Kui Yu, Wen-Qun Xing, written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG)

Abstract

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.

Keywords: Esophageal cancer (EC); clinical trial; neoadjuvant immunochemotherapy; phase III.

Conflict of interest statement

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.

2021 Annals of Translational Medicine. All rights reserved.

Figures

Figure 1
Figure 1
Flowchart of the study. ESCC, oesophageal squamous cell carcinoma; NAIC, neoadjuvant immunochemotherapy; MT, maintain treatment; NAC, neoadjuvant chemotherapy; CRE, clinical response evaluation; QOL, quality of life; NAT, neoadjuvant treatment.

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Source: PubMed

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