Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:27 PM
Study NCT ID:
NCT05833594
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2023-04-16', 'studyFirstSubmitQcDate': '2023-04-16', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adverse events', 'timeFrame': '1 month post treatment', 'description': 'Rate of adverse events (CTCAE V4.0)'}, {'measure': 'Disease Control Rate', 'timeFrame': '1 month post treatment', 'description': 'Disease Control Rate'}], 'secondaryOutcomes': [{'measure': '1-, 2-, 3-year Progression-free survival rate (PFS).', 'timeFrame': '1 to 3 years', 'description': '1-, 2-, 3-year Progression-free survival rate (PFS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma', 'Chemoradiotherapy', 'Immunonutrition', 'Inoperable']}, 'descriptionModule': {'briefSummary': 'Chemoradiotherapy has been a standard modality for inoperable locally advance esophageal carcinoma. The goal of this randomized control study is to compare the feasibility, and survival benefits of whole-course immunonutrition combined with chemoradiotherapy±ICIs for local advanced patients with inoperable esophageal squamous cell carcinoma. The main questions it aims to answer are: • If the feasibility and safety of whole-course immunonutrition combined with chemoradiotherapy±ICIs is better. • If the survival benefits (1, 2 and 3-years progression free survival) of whole-course immunonutrition combined with chemoradiotherapy±ICIs is longer. The Experimental group will receive a combination immunonutrition of omega-3 fatty acids, and glutamine, whereas the control group will receive standard formula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* 18-85 years old;\n* Eastern Cooperative Oncology Group (ECOG) 0-2;\n* Esophageal squamous cell carcinoma;\n* cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;\n* initial unresectable at initial diagnosis confirmed by thoracic surgeons;\n* Treatment naive;\n* No contraindications for adjuvant chemoradiotherapy;\n* Signature of inform consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-85 years old;\n* Eastern Cooperative Oncology Group (ECOG) 0-2;\n* Esophageal squamous cell carcinoma;\n* cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;\n* initial unresectable at initial diagnosis confirmed by thoracic surgeons;\n* Treatment naive;\n* No contraindications for adjuvant chemoradiotherapy;\n* Signature of inform consent.\n\nExclusion Criteria:\n\n* younger than 18 years old or older than 85 years old;\n* ECOG\\>2;\n* Esophageal adenocarcinoma, small-cell cancer and other pathological types;\n* cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;\n* Resectable at initial diagnosis confirmed by thoracic surgeons;\n* Previous treatment of chemotherapy, radiotherapy, and other treatment;\n* Contraindications for chemoradiotherapy;\n* No signature of inform consent.'}, 'identificationModule': {'nctId': 'NCT05833594', 'briefTitle': 'Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Anhui Provincial Hospital'}, 'officialTitle': 'Anhui Provincial Hospita', 'orgStudyIdInfo': {'id': '2023WCIN001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs', 'interventionNames': ['Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs']}, {'label': 'Comparator', 'description': 'Whole-course nutrition Combined With Chemoradiotherapy±ICIs', 'interventionNames': ['Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs']}], 'interventions': [{'name': 'Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.', 'armGroupLabels': ['Comparator', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'dong qian, M.D.', 'role': 'CONTACT', 'email': 'qiankeyu1983@163.com', 'phone': '+86-19156007756'}, {'name': 'Yuan He, M.D.', 'role': 'CONTACT', 'email': 'heyuan3766@126.com', 'phone': '+86-18926243766'}], 'facility': 'Anhui provincial hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'dong qian, M.D.', 'role': 'CONTACT', 'email': 'qiankeyu1983@163.com', 'phone': '+86-19156007756'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}