Clinical trial NCT06125262: Trajectory Analysis of NLR and Its Association With Efficacy of Immunochemotherapy in ESCC.
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma
Immunotherapy
Chemotherapy
Keywords: Advanced Esophageal Carcinoma
Immunochemotherapy
Trajectory analysis
Blood cell counts
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Overall survival and disease-free survival.
timeFrame: From the date of diagnosis to the date of death, assessed up to 100 months
Secondary outcomes:
measure: Pathologic complete response rate
timeFrame: Three to five working days after surgery
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 weeks
measure: Major pathological response
timeFrame: Three to five working days after surgery
measure: Event-free survival
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: guibin Qiao, MD
role: PRINCIPAL_INVESTIGATOR
References: