Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05894369
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2023-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor diameter', 'timeFrame': '1 year', 'description': 'The tumor diameter will be measured to evaluate the therapeutic effect'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year', 'description': 'The survival time of patients is calculated from first treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoadjuvant therapy', 'immunotherapy', 'overall survival', 'efficacy', 'safety'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with esophageal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria：\n\nThe 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\n\nThe 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)"}, 'identificationModule': {'nctId': 'NCT05894369', 'briefTitle': 'Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Renmin Hospital of Wuhan University'}, 'officialTitle': 'Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'WDRY2023-K056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neoadjuvant chemotherapy combi'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Wei Chen', 'role': 'CONTACT', 'email': 'wdrmiit@163.com', 'phone': '86+15671578311'}], 'facility': 'Renmin hosptial of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Yong Shun Chen', 'role': 'CONTACT', 'email': 'yongshun2007@163.com', 'phone': '86+153 2712 2084'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This study is prospective, so it is limited by some uncertainties.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yongshun Chen', 'investigatorAffiliation': 'Renmin Hospital of Wuhan University'}}}}