Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma

NCT ID: NCT05894369

Last Updated: 2024-11-25

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

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-04

Study Completion Date

2025-12-30

Brief Summary

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To evaluate the predictive value and mechanism of inflammatory factors in peripheral blood on the prognosis of patients, and to explore the influencing factors of inflammation and tumor microenvironment on the efficacy of neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer. To explore the predictors of neoadjuvant therapy in patients with esophageal squamous cell carcinoma.

Detailed Description

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Patients with esophageal cancer admitted to Hubei Provincial People's Hospital from May 2023 to December 2024 were collected (the estimated number of patients included is 60). Collect research objects: 1. Baseline information: gender, age, tumor location, T stage, N stage, and BMI, etc. The tumor staging and grading are determined according to the eighth edition of American Joint Committee on Cancer esophageal cancer staging; 2. Laboratory data; Blood routine, liver and kidney function, electrolyte, coagulation function, tumor markers and cytokines were collected before neoadjuvant chemotherapy combined with immunotherapy, after 2 cycles of treatment and after 4 cycles of treatment (if applicable). After every two cycles of treatment, the remission status of the disease was evaluated by CT or gastroscopy in the routine treatment. To evaluate the predictive value and mechanism of peripheral blood inflammatory factors on the prognosis of patients, and to explore the influencing factors of inflammation and tumor microenvironment on the efficacy of neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer.

Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neoadjuvant chemotherapy combi

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

The estimated survival time is less than 6 months; The first diagnosis had distant metastasis Suffering from malignant tumor or accompanying malignant disease in the past 5 years Pregnant or pregnant women. Vulnerable groups (those without informed ability, minors, vagrants, students and subordinates of researchers, employees of bidders)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Yongshun Chen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renmin hosptial of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Shun Chen

Role: CONTACT

86+153 2712 2084

Facility Contacts

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Li Wei Chen

Role: primary

86+15671578311

Other Identifiers

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WDRY2023-K056

Identifier Type: -

Identifier Source: org_study_id

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