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PPIO-009 Tumor Regression Grade and Tumor Location in Esophageal Cancer

PPIO-009 Tumor Regression Grade and Prognosis Analysis of Esophageal Cancer in Different Tumor Location After Neoadjuvant Immunotherapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06453395
Enrollment
248
Registered
2024-06-11
Start date
2023-01-01
Completion date
2024-06-04
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor Regression Grade

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 3.The 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 (934,870 new cases) and the sixth most common cause of cancer death (287,270 new deaths).The 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 252,500 cases of oesophageal cancer and 193,900 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-1/PD-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 1/2 and phase 2 studies have shown a manageable safety profile and preliminary demonstration of efficacy when PD-1/PD-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 quantitatively.TRG 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 patient's 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.

Interventions

OTHERPatients were grouped according to tumor location

Patients were grouped according to tumor location

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* 1\. Clinical diagnosis of Esophageal Squamous Cell Carcinoma 2. patients with clinical TNM (cTNM) stage II-IVA ESCC 3. patients with Neoadjuvant Immunochemotherapy before esophagectomy

Exclusion criteria

* 1\. nonradical resection (R1 or R2) 2. combined with other anticancer therapies (radiotherapy or Targeted drugs) 3. incomplete data or missing follow-up time 4. concurrent or previous presence of malignancies at other sites

Design outcomes

Primary

MeasureTime frameDescription
Tumor regression gradeup to 1 weeksTumor regression grade was defined by NCCN/CAP system. The grading ranges from 0 to 3. TRG is scored as follows: grade 0-No viabal cancer cell (including lymph nodes), grade 1-single cells or small groups of cancer cells, grade 2-single cells or rare small groups of cancer cells, and grade 3-extensive residual cancer with no evident tumor regression.

Secondary

MeasureTime frameDescription
Disease-free survivalAbout 2 years postoperativelyDisease-free survival (DFS) was defined as the time from the date of surgery to recurrence, metastasis, and death from any cause.
Overall survivalAbout 2 years postoperativelyOverall survival (OS) was defined as the time from the date of surgery to death from any cause or last follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026