Trajectory Analysis of NLR and Its Association With Efficacy of Immunochemotherapy in ESCC.

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06125262

Collaborator

(none)

100

Enrollment

Location

22.5

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Conduct a retrospective and prospective study to confirm the association between blood cells counts and the efficacy and safety in immunochemotherapy in patients with advanced esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma Immunotherapy Chemotherapy

Detailed Description

Studies have already demonstrated the feasibility of prognostic role of protein biomarkers change during the treatment trajectory of patients in several carcinoma,However, no study focused on the value of trajectory analysis of blood cells counts of Immunochemotherapy in patients with advanced esophageal cancer.

The investigators plan to analyze the dynamic change of blood cells counts longitudinally from preoperation to long term follow-up in advanced esophageal cancer and predict the efficacy and safety of immunochemotherapy.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Trajectory Analysis of Neutrophil to Lymphocyte Ratio（NLR） and Its Association With Efficacy of Immunochemotherapy in Esophageal Squamous Cell Carcinoma: A Retrospective Cohort Study

Actual Study Start Date :

Sep 16, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jul 31, 2025

Outcome Measures

Primary Outcome Measures

Overall survival and disease-free survival. [From the date of diagnosis to the date of death, assessed up to 100 months]
Overall survival rate

Secondary Outcome Measures

Pathologic complete response rate [Three to five working days after surgery]
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Objective Response Rate (ORR) [Up to 24 weeks]
Immune-modified Response Evaluation Criteria In SolidTumors (iRECIST) criteria defined complete response and partial response
Major pathological response [Three to five working days after surgery]
ess than 10% residual viable tumor follow neoadjuvant therapy
Event-free survival [From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months]
Event-free survival (EFS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathologically confirmed esophageal squamous cell carcinoma
Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4a N1-2 M0, cT3-T4a N0M0)
Treatment-naive
Expected life span > 6 months
Aged 18 - 75 years old
Adequate organ functions
Performance Status (PS) 0-2
Participants are fully informed about the whole study and are willing to sign the informed consent