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

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma; Immunotherapy; Chemotherapy

• Registration Number: NCT06125262
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

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 Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-05
• Study First Posted: 2023-11-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28
• Primary Completion: 2024-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China