Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT06389760
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C501466', 'term': 'nimotuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free survival (DFS)', 'timeFrame': 'Up to 24 months', 'description': 'The time from the date of surgery to the disease recurrence or death, whichever is earlier.'}], 'secondaryOutcomes': [{'measure': 'overall survival (OS)', 'timeFrame': 'Up to 24 months', 'description': 'The time from the date of surgery to death due to any cause.'}, {'measure': 'adverse events', 'timeFrame': 'Up to 30 days after last administration', 'description': 'Frequency and severity of adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nimotuzumab', 'mFOLFIRINOX', 'adjuvant therapy', 'pancreatic cancer', 'GX'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, single-arm, open-label study. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX/GX for postoperative adjuvant treatment of pancreatic cancer.', 'detailedDescription': 'This clinical study is designed as a prospective, multicenter, single arm, open-label study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX/GX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included overall survival (OS) and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age 18 years or older, gender unlimited;\n* 2\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 3\\. Had undergone complete macroscopic resection for pancreatic cancer (R0 or R1 resection) with histological confirmation and with no evidence of distant metastasis as demonstrated by imaging;\n* 4\\. No prior tumor therapy;\n* 5\\. Adequate organ and bone marrow function, defined as follows: White blood cells (WBC) ≥ 3.0×10\\^9/L; absolute neutrophil count (ANC)≥1.5×10\\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1×ULN or estimated creatinine clearance ≥ 50 mL/min;\n* 6\\. Left ventricular ejection fraction (LVEF) ≥ 50%;\n* 7\\. Fertile subjects are willing to take contraceptive measures during the study period.\n* 8\\. good compliance and signed informed consent voluntarily\n\nExclusion Criteria:\n\n* 1\\. Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;\n* 2\\. Participated in other drug clinical trials within 4 weeks;\n* 3\\. History of other malignancies;\n* 4\\. Immunodeficiency, or other immune-related disorders requiring medical intervention;\n* 5\\. Postoperative complications such as bleeding;\n* 6\\. Woman who are pregnant or breastfeeding;\n* 7\\. Drug abuse, or clinical, psychological or social factors that may have an impact on informed consent or the implementation of the study;\n* 8.Known allergy to prescription or any component of the prescription used in this study, including nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, and capecitabine.'}, 'identificationModule': {'nctId': 'NCT06389760', 'briefTitle': 'Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study', 'orgStudyIdInfo': {'id': 'IST-Nim-PC-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimotuzumab+ mFOLFIRINOX/GX', 'description': 'Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.', 'interventionNames': ['Drug: Nimotuzumab', 'Drug: mFOLFIRINOX', 'Drug: GX']}], 'interventions': [{'name': 'Nimotuzumab', 'type': 'DRUG', 'otherNames': ['Taixinsheng'], 'description': 'When combined with the mFOLFIRINOX regimen, nimotuzumab (nimo) will be administered at a dose of 400mg on Day 1 and 15 of a 28-day cycle (6 cycles). When combined with the GX regimen, nimotuzumab will be given at 400mg on Day 1 and 8 of a 21-day cycle (8 cycles).', 'armGroupLabels': ['Nimotuzumab+ mFOLFIRINOX/GX']}, {'name': 'mFOLFIRINOX', 'type': 'DRUG', 'description': 'Patients will receive mFOLFIRINOX as follows: Oxaliplatin 65 mg/m2 on Day 1 and 15 of a 28-day cycle; Irinotecan 130 mg/m2 on Day 1 and 15 of a 28-day cycle; Leucovorin(LV) 200 mg/m2 Day 1 and 15 of a 28-day cycle; 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day 1 and 15 of a 28-day cycle (6 cycles).', 'armGroupLabels': ['Nimotuzumab+ mFOLFIRINOX/GX']}, {'name': 'GX', 'type': 'DRUG', 'description': 'Patients will receive GX regimen as follows: Gemcitabine 1000 mg/m2 on Day 1 and 8 of a 21-day cycle; capecitabine 2000 mg/m2 on d1-14 a 21-day cycle(8 cycles).', 'armGroupLabels': ['Nimotuzumab+ mFOLFIRINOX/GX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Du, M.D. Ph.D', 'role': 'CONTACT', 'email': 'dujunglyy@163.com', 'phone': '+86-025-83106666'}, {'name': 'Juan Du, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Juan Du, MD', 'role': 'CONTACT', 'email': 'dujuanglyy@163.com', 'phone': '86-25-83106666'}], 'overallOfficials': [{'name': 'Juan Du, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}