Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-01 @ 4:23 AM
Study NCT ID:
NCT06398405
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], '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'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045651', 'term': 'epigallocatechin gallate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-05-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Choking symptom objective response rate', 'timeFrame': 'baseline and up to 7 days post-treatment', 'description': "Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally)"}, {'measure': 'Pain symptom objective response rate', 'timeFrame': 'baseline and up to 7 days post-treatment', 'description': 'Pain when swallowing was assessed by numerical rating scale (0-5, with 0 being none and 5 being worst pain imaginable)'}, {'measure': 'Imaging objective response rate', 'timeFrame': 'Change from Baseline esophageal stenosis size at 7 days', 'description': 'Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT'}], 'secondaryOutcomes': [{'measure': 'prealbumin change', 'timeFrame': 'baseline and up to 7 days post-treatment', 'description': 'The prealbumin values were tested by biochemical analysis'}, {'measure': 'Albumin change', 'timeFrame': 'baseline and up to 7 days post-treatment', 'description': 'The albumin values were tested by biochemical analysis'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'baseline and up to 7 days post-treatment', 'description': 'participants will be followed for the duration of EGCG treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal Cancer', 'Dysphagia, Esophageal', 'Epigallocatechin gallate'], 'conditions': ['Esophageal Cancer', 'Dysphagia, Esophageal', 'Epigallocatechin Gallate']}, 'descriptionModule': {'briefSummary': 'The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* confirmed pathological esophageal squamous cell carcinoma\n* ≥18 years old\n* the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* no previous anti-tumor treatment\n* no esophageal bleeding or fistula\n* adequate hemocyte count, normal hepatic and renal functions\n* Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score\n\nExclusion Criteria:\n\n* lactating or pregnant women\n* known hypersensitivity or allergy to any kind green tea extract\n* placement of small intestinal feeding tube or endoscopic stent treatment\n* unable or refusing to take oral liquids"}, 'identificationModule': {'nctId': 'NCT06398405', 'briefTitle': 'A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial', 'orgStudyIdInfo': {'id': 'GTEEC2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EGCG ARM', 'description': 'Studies investigating EGCG (purity 95% by high-performance liquid chromatography, obtained from Zhejiang Ningbo HEP Biotech Co., Ltd.) utilized a concentration of 4400 umol/L dissolved in 0.9% saline solution, which is administered three times a day for 1 week. Freshly prepared each time, the EGCG was administered 10 minutes before meals. The repeated slow swallowing of 30 ml of the EGCG solution was essential to ensure sustained contact of the drug on the esophageal walls', 'interventionNames': ['Other: Epigallocatechin-3-gallate']}], 'interventions': [{'name': 'Epigallocatechin-3-gallate', 'type': 'OTHER', 'description': 'Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L', 'armGroupLabels': ['EGCG ARM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hanxi Zhao, MD', 'role': 'CONTACT', 'email': 'zhx87520052@163.com', 'phone': '86-531-67626996'}], 'facility': 'Shandong Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Han Xi Zhao', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}