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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05894369
Enrollment
10
Registered
2023-06-08
Start date
2023-05-04
Completion date
2025-12-30
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

neoadjuvant therapy, immunotherapy, overall survival, efficacy, safety

Brief summary

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

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.

Interventions

None listed

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

: The patient's age between 18 to 80 years old; Esophageal squamous cell carcinoma with definite pathological diagnosis and II-IVA clinical stage Preoperative neoadjuvant chemotherapy combined with immunotherapy The score of eastern cooperative oncology group is 0 \ 1

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)

Design outcomes

Primary

MeasureTime frameDescription
Tumor diameter1 yearThe tumor diameter will be measured to evaluate the therapeutic effect

Secondary

MeasureTime frameDescription
Overall survival1 yearThe survival time of patients is calculated from first treatment

Countries

China

Contacts

Primary ContactYong Shun Chen
yongshun2007@163.com86+153 2712 2084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026