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

NCT06453395 | Completed

• 1 other identifier: NO:2023(289)
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor Regression Grade

Outcome Measures

Primary Outcomes (1)

• Tumor regression grade

  Tumor 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.

  up to 1 weeks

Secondary Outcomes (2)

• Disease-free survival

  About 2 years postoperatively

• Overall survival

  About 2 years postoperatively

Study Arms (3)

upper thoracic case

Cervical esophagus to lower border of the azygos vein

Other: Patients were grouped according to tumor location

Middle thoracic case

Cervical esophagus to lower border of the azygos vein

Other: Patients were grouped according to tumor location

Lower thoracic case

Lower border of the inferior pulmonary vein to the stomach, including the esophagogastric junction

Other: Patients were grouped according to tumor location

Interventions

Patients were grouped according to tumor location OTHER

Patients were grouped according to tumor location

Lower thoracic case; Middle thoracic case; upper thoracic case

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From January 1, 2019 to October 1, 2023 thoracoscopic esophagectomies for ESCC of the thoracic esophagus were performed in the Department of Thoracic Surgery, Daping Hospital, Army Medical University (Chongqing, China)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: January 1, 2023
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)