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)

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.

Toripalimab in advanced biliary tract cancer

“…Toripalimab, a new type of recombinant humanized IgG4 monoclonal antibody against PD-1, has shown promising efficacy and safety in a series of clinical studies. 7 , 8 , 9 , 10 However, there is little evidence as to whether a regimen that combines toripalimab with GS would lead to comparable or better outcomes when administered in patients with advanced BTCs.…”

Neoadjuvant Immunotherapy Combined Chemotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma: A Propensity Score-Matched Study

“…Recently, pembrolizumab plus chemotherapy has been recommended as first-line treatment for advanced EC ( 10 ). Considering the promising results in advanced EC, it is reasonable to explore the efficacy and safety of neoadjuvant immunotherapy combined chemotherapy (nICT) ( 11 , 12 ).…”

Delayed Diagnosis and Treatment of Cancer Patients During the COVID-19 Pandemic in Henan, China: An Interrupted Time Series Analysis

“…Here, we explored the influence of the COVID-19 pandemic and lockdown policies on cancer patients in Henan by interrupted time series (ITS) analysis using autoregressive integrated moving average (ARIMA) models, which take the autocorrelation, underlying long-term trends, and seasonality into consideration. As the only tertiary cancer hospital in Henan, Henan Cancer Hospital has a bed capacity of over 3,000, about 660,000 outpatient visits, and 180,000 hospitalizations annually ( 19 ). Henan Cancer Hospital is an oncology specialist hospital and, therefore, does not admit patients with COVID-19.…”