Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT04207918
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2019-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'C501466', 'term': 'nimotuzumab'}, {'id': 'C079198', 'term': 'S 1 (combination)'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control rate', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with acute toxicities', 'timeFrame': '2-3 months', 'description': 'Acute toxicities are evaluated by NCI-CTC version 5.0'}, {'measure': 'R0 resection rate', 'timeFrame': '2-3 months', 'description': 'The surgical procedure was radical esophagectomy after neoadjuvant therapy.'}, {'measure': 'Pathological response rate', 'timeFrame': '2-3 months', 'description': 'Pathological response were classified into five grades according to Mandard Tumor Regression Grade.'}, {'measure': 'Tumor Response rate', 'timeFrame': '2-3 months'}, {'measure': 'Incidence of perioperative complications', 'timeFrame': '2-3 months', 'description': 'During hospital stay and within the first 30 days after completion of surgery.'}, {'measure': 'Overall survival', 'timeFrame': '1 year, 2 year'}, {'measure': 'Progression free survival', 'timeFrame': '1 year, 2 year'}, {'measure': 'Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis', 'timeFrame': '1 year, 2 year'}, {'measure': 'ctDNA in predicting tumor response rate and prognosis', 'timeFrame': '1 year, 2 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer', 'Chemoradiotherapy', 'Nimotuzumab', 'Unresectable Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years\n* Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)\n* Primary treatment accepted in Chinese Academy of Medical Sciences\n* KPS ≥70\n* NRS score ≥2\n* Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma\n* Normal organ and marrow function as defined below:\n\nHemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit\n\n* Informed consent\n\nExclusion Criteria:\n\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer\n* Any prior chemotherapy or other cancer treatment prior to this protocol\n* With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation\n* History of allergic reactions attributed to contrast medium, similar chemical or biologic complex\n* Existing esophageal fistula, perforation and cachexia\n* Existing active infection such as active tuberculosis and hepatitis\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia\n* Participation in other clinical trials currently or within 4 weeks of selection\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT04207918', 'briefTitle': 'A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)', 'orgStudyIdInfo': {'id': '19/291-2075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant Chemoradiotherapy（NCRT）', 'description': 'NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Nimotuzumab', 'Drug: S-1']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': '44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.', 'armGroupLabels': ['Neoadjuvant Chemoradiotherapy（NCRT）']}, {'name': 'Nimotuzumab', 'type': 'DRUG', 'description': '400mg, by intravenous infusion once a week in 4-6 weeks.', 'armGroupLabels': ['Neoadjuvant Chemoradiotherapy（NCRT）']}, {'name': 'S-1', 'type': 'DRUG', 'description': '40-60mg/m2/d，orally twice a day concurrently with radiotherapy.', 'armGroupLabels': ['Neoadjuvant Chemoradiotherapy（NCRT）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'XIN WANG', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}