Clinical trial NCT05894369: Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
Official title: Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Keywords: neoadjuvant therapy
immunotherapy
overall survival
efficacy
safety
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with esophageal cancer

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.

Eligibility 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)

Primary outcomes:
measure: Tumor diameter
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin hosptial of Wuhan University
state: Hubei
Study officials:
References: