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

December 27, 2023 updated by: GuiBin Qiao, Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Guibin Qiao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent neoadjuvant immunochemotherapy at Guangdong provincial peoples hospital and The First Affiliated Hospital of Shantou University.

Description

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

Exclusion Criteria:

  • Previous history of thoracic surgery or radiation
  • Cervical or multi-origin esophageal cancer
  • Known or suspected experimental drug allergy
  • Pregnant or lactating women
  • Esophagomediastinal fistula
  • Peripheral neuropathy
  • Previous cancer history other than esophageal cancer
  • Severe organ function deterioration that can not tolerate neoadjuvant therapy
  • Previous autoimmune diseases
  • diabetic history > 10 years
  • interstitial pulmonary disease, non-infectious pulmonitis
  • Active type B hepatitis
  • Any other conditions that may affect patients' safety and compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival and disease-free survival.
Time Frame: From the date of diagnosis to the date of death, assessed up to 100 months
Overall survival rate
From the date of diagnosis to the date of death, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic complete response rate
Time Frame: Three to five working days after surgery
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Three to five working days after surgery
Major pathological response
Time Frame: Three to five working days after surgery
ess than 10% residual viable tumor follow neoadjuvant therapy
Three to five working days after surgery
Objective Response Rate (ORR)
Time Frame: Up to 24 weeks
Immune-modified Response Evaluation Criteria In SolidTumors (iRECIST) criteria defined complete response and partial response
Up to 24 weeks
Event-free survival
Time Frame: 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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: guibin Qiao, MD, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RICE-Circulation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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