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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125262
• Other study ID #: RICE-Circulation
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: December 2023
• Source: Guangdong Provincial People's Hospital
• Contact: guibin Qiao, MD
• Phone: 13602749153
• Email: guibinqiao[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Chemotherapy
• Esophageal Squamous Cell Carcinoma
• Immunotherapy

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival and disease-free survival.	Overall survival rate	From the date of diagnosis to the date of death, assessed up to 100 months
Secondary	Pathologic complete response rate	The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery	Three to five working days after surgery
Secondary	Objective Response Rate (ORR)	Immune-modified Response Evaluation Criteria In SolidTumors (iRECIST) criteria defined complete response and partial response	Up to 24 weeks
Secondary	Major pathological response	ess than 10% residual viable tumor follow neoadjuvant therapy	Three to five working days after surgery
Secondary	Event-free survival	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