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

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

NCT ID: NCT06125262

Condition: Esophageal Squamous Cell Carcinoma
Immunotherapy
Chemotherapy

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma

Conditions: Keywords:
Advanced Esophageal Carcinoma
Immunochemotherapy
Trajectory analysis
Blood cell counts

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

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.

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Guangdong Provincial People's Hospital

Address:
City: Guangzhou
Zip: 510080
Country: China

Status: Recruiting

Contact:
Last name: Guibin Qiao, MD

Phone: 13602749153
Email: guibinqiao@126.com

Investigator:
Last name: Guibin Qiao, MD
Email: Principal Investigator

Start date: November 1, 2022

Completion date: July 31, 2025

Lead sponsor:
Agency: Guangdong Provincial People's Hospital
Agency class: Other

Source: Guangdong Provincial People's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06125262