Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT06410651
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma
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': 'C501466', 'term': 'nimotuzumab'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2024-05-05', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': '4 months after initiation of induction chemoimmunotherapy', 'description': 'Minimal distance tumor/circumferential resection margin (CRM) \\> 1 mm.'}], 'secondaryOutcomes': [{'measure': 'Pathological complete response', 'timeFrame': '4 months after initiation of induction chemoimmunotherapy', 'description': 'the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes'}, {'measure': 'Event-free survival', 'timeFrame': '1 year after all treatment', 'description': 'the time from start of induction chemo(immuno)therapy to progression, relapse, all-cause death, or the last day of follow-up'}, {'measure': 'Side effects during chemoradiotherpay', 'timeFrame': '1 month after chemoradiotherapy', 'description': 'the time from start of chemoradiotherapy to 1 month after chemoradiotherapy'}, {'measure': 'Postoperative complications', 'timeFrame': '1 month after surgery'}, {'measure': 'Overall survival', 'timeFrame': '1 year after all treatment', 'description': 'the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer', 'Nimotuzumab', 'Chemoradiotherapy', 'Chemotherapy', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': 'Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc.\n\nNimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies.\n\nThe current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed esophageal squamous cell carcinoma. Tumor response was evaluated as stable or locoregionally progresive disease or assessed by surgeons being unresectable (without distant metastasis) after induction chemo(immuno)therapy.\n* Cycles of induction chemo(immuno)therapy was 2-4.\n* KPS score ≥70.\n* Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;\n\nExclusion Criteria:\n\n* Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n* At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites\n* There are active infections, such as active tuberculosis and hepatitis\n* There are contraindications to targeted therapy.'}, 'identificationModule': {'nctId': 'NCT06410651', 'briefTitle': 'Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma After Failure of Chemotherapy：A Phase II Study', 'orgStudyIdInfo': {'id': 'NCC4536'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimotuzumab concurrent with chemordiotherapy followed by surgery', 'interventionNames': ['Combination Product: Nimotuzumab with chemoradiotherapy']}], 'interventions': [{'name': 'Nimotuzumab with chemoradiotherapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA，orally twice daily on radiotherapy days.', 'armGroupLabels': ['Nimotuzumab concurrent with chemordiotherapy followed by surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Wang, doctor', 'role': 'CONTACT', 'email': 'berly_wx2000@163.com', 'phone': '13311583220'}], 'facility': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xin Wang, doctor', 'role': 'CONTACT', 'email': 'beryl_wx2000@163.com', 'phone': '13311583220'}, {'name': 'Guojie Feng, B.M', 'role': 'CONTACT', 'email': 'fenggj18243017306@163.com', 'phone': '16601212285'}]}, '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'}}}}