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

Guangdong Provincial People's Hospital100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Esophageal Squamous Cell Carcinoma Immunotherapy Chemotherapy

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Overall survival and disease-free survival.

Overall survival rate

Time frame: From the date of diagnosis to the date of death, assessed up to 100 months

Secondary Outcomes

Pathologic complete response rate

The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

Time frame: Three to five working days after surgery

Objective Response Rate (ORR)

Immune-modified Response Evaluation Criteria In SolidTumors (iRECIST) criteria defined complete response and partial response

Time frame: Up to 24 weeks

Major pathological response

ess than 10% residual viable tumor follow neoadjuvant therapy

Time frame: Three to five working days after surgery

Event-free survival

Event-free survival (EFS)

Time frame: 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

Central Contacts

guibin Qiao, MD

CONTACT

13602749153 guibinqiao@126.com

Data from ClinicalTrials.gov

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