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

NCT ID: NCT06125262

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Esophageal Squamous Cell Carcinoma Immunotherapy Chemotherapy

Keywords

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Advanced Esophageal Carcinoma Immunochemotherapy Trajectory analysis Blood cell counts

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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GuiBin Qiao

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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guibin Qiao, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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guibin Qiao, MD

Role: CONTACT

Phone: 13602749153

Email: [email protected]

Facility Contacts

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Guibin Qiao, MD

Role: primary

Other Identifiers

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RICE-Circulation

Identifier Type: -

Identifier Source: org_study_id