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Trial Title:
Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05894369
Condition:
Esophageal Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Conditions: Keywords:
neoadjuvant therapy
immunotherapy
overall survival
efficacy
safety
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients with esophageal cancer
Sampling method:
Probability Sample
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renmin hosptial of Wuhan University
Address:
City:
Wuhan
Zip:
430060
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Wei Chen
Phone:
86+15671578311
Email:
wdrmiit@163.com
Start date:
May 4, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Renmin Hospital of Wuhan University
Agency class:
Other
Source:
Renmin Hospital of Wuhan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05894369
