Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453395
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-06-04
Brief Title:
PPIO-009 Tumor Regression Grade and Tumor Location in Esophageal Cancer
Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Organization:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study Overview
Official Title:
PPIO-009 Tumor Regression Grade and Prognosis Analysis of Esophageal Cancer in Different Tumor Location After Neoadjuvant Immunotherapy
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At present the evaluation of the effect of neoadjuvant chemoradiotherapy combined with immunotherapy for locally advanced esophageal cancer is mainly based on postoperative pathology among which the pathological assessment of tumor regression grade TRG and TNM staging are the basis for the routine pathological diagnosis of esophageal cancer and the College of American Pathologists divides the TRG after neoadjuvant therapy to esophageal cancer into four grades 0 1 2 and 3The residual primary tumor in the resection specimen following neoadjuvant therapy is associated with shorter overall survival Therefore the prediction of TRG after neoadjuvant therapy is vital for patients We aim to seek to identify factors associated with TRG system as defined by the NCCN
Detailed Description:
Oesophageal cancer is the eighth most common cancer globally 934870 new cases and the sixth most common cause of cancer death 287270 new deathsThe incidence prevalence and histological type of oesophageal cancer vary geographically with about 75 of cases occurring in Asia with China having the highest share accounting for about 50 of the total cases and cancer-specific deaths According to the National Bureau of Statistics of China Statistics 2022 there were 252500 cases of oesophageal cancer and 193900 deaths in China in 2016 making oesophageal cancer the sixth most common cancer and the fifth leading cause of cancer death in China The etiology of the two most common histological subtypes esophageal squamous cell carcinoma ESCC and adenocarcinoma varies widely In the West heavy alcohol consumption and smoking and their synergistic effects are the main risk factors for ESCC However in low-income countries such as parts of Asia and sub-Saharan Africa the main risk factors for ESCC which typically accounts for more than 90 of all oesophageal cancer cases have not been elucidated
Preclinical studies have shown that the PD-1PD-L1 axis can be activated early in solid tumours and a durable protective effect may occur with preoperative induction of the immune response Considering the dramatic decrease in tumour antigens after surgical resection and the removal of intact blood vessels and lymph nodes delivering the drug may affect the immunotherapeutic efficacy the use of immunotherapy preoperatively may be more effective Several phase 12 and phase 2 studies have shown a manageable safety profile and preliminary demonstration of efficacy when PD-1PD-L1 inhibitors were added to perioperative therapy in resectable EC subjects PD-1 inhibitors have demonstrated significant benefit in both second-line therapy and first-line therapy Given the evidence of antitumour activity of immunotherapy in patients with ESCC and the continuing need to improve survival and reduce recurrence rates in resectable oesophageal cancer a number of studies exploring the antitumour activity of immunotherapy in the treatment of resectable disease have tentatively shown promise as a neoadjuvant therapy
Currently after patients receive neoadjuvant therapy tumour cell regression can occur with a variety of histological changes such as tumour cell necrosis and apoptosis fibrous tissue proliferation inflammatory cell infiltration foam cell aggregation cell-free mucus production and formation of mucus pools as well as calcified foci formation However not all tumours produce the above regression reactions after treatment fibrohistiocytosis and inflammatory cell infiltration are the most common histological regression changes and in order to assess the clinical therapeutic efficacy of the tumour tumour regression needs to be graded quantitativelyTRG is a quantitative analysis of the pathology of tumours resected after neoadjuvant chemotherapy to clarify the therapeutic efficacy of chemotherapy or targeted drugs on tumours and to predict the patients postoperative recurrence and metastasis Metastasis It was firstly used to assess the efficacy of oesophageal cancer after concurrent radiotherapy and then gradually used to assess the efficacy of oesophageal cancer The current assessment of post-radiotherapy samples is mainly based on the proportion of residual tumour components and fibrosis to grade pathological regression Currently the main methods for TRG scoring after neoadjuvant radiotherapy include NCCN AJCC and other standards
Currently based on the data of pre-surgical clinical studies the remission rate after neoadjuvant therapy varies in different oesophageal segments which may indicate that the difference in blood supply of oesophageal cancer in different segments affects the blood drug concentration leading to different clinical outcomes in patients with oesophageal cancer in different segments In order to better treat patients in different segments it is necessary to establish a prediction model based on the clinical data of patients in different oesophageal segments for better clinical decision-making
Preclinical studies have shown that the PD-1PD-L1 axis can be activated early in solid tumours and a durable protective effect may occur with preoperative induction of the immune response Considering the dramatic decrease in tumour antigens after surgical resection and the removal of intact blood vessels and lymph nodes delivering the drug may affect the immunotherapeutic efficacy the use of immunotherapy preoperatively may be more effective Several phase 12 and phase 2 studies have shown a manageable safety profile and preliminary demonstration of efficacy when PD-1PD-L1 inhibitors were added to perioperative therapy in resectable EC subjects PD-1 inhibitors have demonstrated significant benefit in both second-line therapy and first-line therapy Given the evidence of antitumour activity of immunotherapy in patients with ESCC and the continuing need to improve survival and reduce recurrence rates in resectable oesophageal cancer a number of studies exploring the antitumour activity of immunotherapy in the treatment of resectable disease have tentatively shown promise as a neoadjuvant therapy
Currently after patients receive neoadjuvant therapy tumour cell regression can occur with a variety of histological changes such as tumour cell necrosis and apoptosis fibrous tissue proliferation inflammatory cell infiltration foam cell aggregation cell-free mucus production and formation of mucus pools as well as calcified foci formation However not all tumours produce the above regression reactions after treatment fibrohistiocytosis and inflammatory cell infiltration are the most common histological regression changes and in order to assess the clinical therapeutic efficacy of the tumour tumour regression needs to be graded quantitativelyTRG is a quantitative analysis of the pathology of tumours resected after neoadjuvant chemotherapy to clarify the therapeutic efficacy of chemotherapy or targeted drugs on tumours and to predict the patients postoperative recurrence and metastasis Metastasis It was firstly used to assess the efficacy of oesophageal cancer after concurrent radiotherapy and then gradually used to assess the efficacy of oesophageal cancer The current assessment of post-radiotherapy samples is mainly based on the proportion of residual tumour components and fibrosis to grade pathological regression Currently the main methods for TRG scoring after neoadjuvant radiotherapy include NCCN AJCC and other standards
Currently based on the data of pre-surgical clinical studies the remission rate after neoadjuvant therapy varies in different oesophageal segments which may indicate that the difference in blood supply of oesophageal cancer in different segments affects the blood drug concentration leading to different clinical outcomes in patients with oesophageal cancer in different segments In order to better treat patients in different segments it is necessary to establish a prediction model based on the clinical data of patients in different oesophageal segments for better clinical decision-making
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None