Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-31 @ 4:32 AM
Study NCT ID:
NCT04822103
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced 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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-28', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 24 weeks', 'description': 'Objective Response Rate'}, {'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'}, {'measure': 'Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses', 'timeFrame': 'Up to 36 weeks', 'description': 'The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.'}], 'secondaryOutcomes': [{'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'}, {'measure': 'R0 resection rate', 'timeFrame': 'Three to five working days after surgery', 'description': 'The R0 resection rate of esophagectomy'}, {'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': 'Major pathological response', 'timeFrame': 'Three to five working days after surgery', 'description': '≤10% residual viable tumor follow NAIC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal cancer', 'real-world study', 'immunotherapy', 'chemotherapy'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '40146232', 'type': 'DERIVED', 'citation': 'Yang W, Ma SC, Fang Z, Liu Y, Zhang X, Wang F, Wang C, Wang Y, Wang X, Chen W, Luo H, Yang L, Zhang S, Zeng B, Liu Z, Ou Q, Cai J, Yeung SJ, Cheng C. TP53-centric ctDNA complements PET/CT for non-invasive assessment of pathological complete response and survival after neoadjuvant immunochemotherapy in esophageal squamous cell carcinoma: a prospective cohort study. Int J Surg. 2025 May 1;111(5):3256-3268. doi: 10.1097/JS9.0000000000002341.'}]}, 'descriptionModule': {'briefSummary': 'The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically diagnosed as esophageal squamous cell carcinoma\n* KPS≥80\n* Adequate organ function\n* No distant metastasis\n* The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist\n\nExclusion Criteria:\n\n* incomplete medical record which affects statistical analysis\n* have participated in previous interventional clinical trials\n* other situations evaluated by investigators not meet the enrollment'}, 'identificationModule': {'nctId': 'NCT04822103', 'briefTitle': 'A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer', 'orgStudyIdInfo': {'id': 'RICE-retro'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '515031', 'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shantou Central Hospital', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}], 'overallOfficials': [{'name': 'Guibin Qiao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "The People's Hospital of Gaozhou", 'class': 'OTHER'}, {'name': 'The General Hospital of Southern Theater Command', 'class': 'OTHER'}, {'name': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Shantou University Medical College', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Shantou Central Hospital', 'class': 'OTHER'}, {'name': "Shenzhen People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}