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

NCT06125262 | Unknown

• 1 other identifier: RICE-Circulation
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma; Immunotherapy; Chemotherapy

Keywords

Advanced Esophageal Carcinoma; Immunochemotherapy; Trajectory analysis; Blood cell counts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pathologic complete response rate

  Three to five working days after surgery

• Objective Response Rate (ORR)

  Up to 24 weeks

• Major pathological response

  Three to five working days after surgery

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood cell counts recorded at baseline and after the first cycle of treatment

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• guibin Qiao, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

guibin Qiao, MD

CONTACT

13602749153; guibinqiao@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: November 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

CN (1)