Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-31 @ 4:25 AM
Study NCT ID:
NCT05615103
Status:
UNKNOWN
Last Update Posted:
2022-11-29
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-24', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic complete response rate (pCR)', 'timeFrame': 'Three to five working days after surgery', 'description': 'The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'from the date of diagnosis to the date of death, assessed up to 100 months', 'description': 'Overall survival rate'}, {'measure': 'Event-free survival', 'timeFrame': 'from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months', 'description': 'EFS'}, {'measure': 'Safety as measured by number of participants with Grade 3 and 4 adverse events', 'timeFrame': 'Up to 12 weeks', 'description': 'Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': "Treatment with immune checkpoint inhibitors such as programmed death receptor 1 (PD-1 inhibitors) for advanced and metastatic esophageal squamous cell carcinoma (ESCC) significantly improves patients' overall survival compared to chemotherapy alone. Despite this milestone breakthrough, immunochemotherapy also has known limitations. Indeed, only 45-72% of patients achieved objective responses. It is urgent to find out easily-determined and convenient biomarkers to identify patients who will benefit from such treatment modality. Due to the luminal structure of the esophagus, the exact diameter of esophageal tumor cannot be precisely measured per RECIST 1.1. Moreover, the definition of the metastatic lymph node in which the short-axis lengths should be longer than 1.5 cm hinders the risk of missing the smaller metastatic lymph node foci. Thus, it is difficult to implement morphology-based criteria for evaluating the neoadjuvant immunochemotherapy response. The current study aimed to investigate the role of iPERCIST in predicting tumor response and the short-term overall survival of patients with locally advanced ESCC after neoadjuvant immunochemotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients were selected according to the following criteria: pathologically confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after neoadjuvant immunochemotherapy. All patients were treatment-naïve and had adequate cardiopulmonary function. The exclusion criteria included previous autoimmune disease; unable to complete planned treatment courses and no complete follow-up PET-CT scan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologically confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after neoadjuvant immunochemotherapy.\n* treatment-naïve and had the adequate cardiopulmonary function\n\nExclusion Criteria:\n\n* previous autoimmune disease\n* unable to complete planned treatment courses and no complete follow-up PET-CT scan'}, 'identificationModule': {'nctId': 'NCT05615103', 'acronym': 'POSITRON', 'briefTitle': 'The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': "The Efficiency of 18F-FDG PET-CT for Predicting Advanced Oesophageal Squamous Cell Carcinoma Patients' Tumor Response to Immunochemotherapy in the Neoadjuvant Setting", 'orgStudyIdInfo': {'id': 'POSITRON'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guibin Qiao, MD', 'role': 'CONTACT', 'email': 'guibinqiao@126.com', 'phone': '13602749153'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Guibin Qiao, MD', 'role': 'CONTACT', 'email': 'guibinqiao@126.com', 'phone': '13602749153'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital of Shantou University Medical College', 'class': 'OTHER'}, {'name': "Shenzhen People's Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Cancer Hospital of Guangzhou Medical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}