Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 9:59 AM
Study NCT ID:
NCT03400592
Status:
UNKNOWN
Last Update Posted:
2018-01-17
First Post:
2015-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'C501466', 'term': 'nimotuzumab'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2015-10-10', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months', 'description': 'CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years after first enrollment', 'description': 'Overall survival is defined as the time from the date of enrollment to the date of the death from any cause.'}, {'measure': 'Progression free survival', 'timeFrame': '3 years after first enrollment', 'description': 'Progression Free Survival is defined as the time from the date of enrollment to the date of progression or death from any cause'}, {'measure': 'Disease control rate', 'timeFrame': 'From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months', 'description': 'Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response'}, {'measure': 'Safety', 'timeFrame': 'From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}, {'measure': 'Potential predictive biomarkers of nimotuzumab', 'timeFrame': '3 years after first enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric adenocarcinoma', 'EGFR', 'Irinotecan', 'Nimotuzumab', 'biomarker'], 'conditions': ['Stomach Neoplasms']}, 'descriptionModule': {'briefSummary': 'The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.', 'detailedDescription': "The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:\n* Willing to sign ICF\n* Above 18 years\n* KPS score≥70\n* Expected survival time more than 90 days\n* Subjects with EGFR overexpression (2+ or 3+ in IHC)\n* With target lesions in spiral CT or MRI examination within 30 days\n* Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.\n* Lab test of baseline meet following criteria\n* Hemoglobin higher than 9.0g/dL\n* Neutrophil higher than 1,500/mm3\n* PLT higher than 10.0 104/mm3\n* Bilirubin lower than 1.5 times of upper limit of normal range\n* AST,ALT,ALP lower than 2.5 times of upper limit of normal range\n* Creatinine lower than upper limit of normal range\n* When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range\n\nExclusion Criteria:\n\n* Patients who have received irinotecan\n* Patients who are allergic to irinotecan or nimotuzumab.\n* Other active malignancy within the last 5 years\n* Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures\n* Investigator judge not eligible to this trial'}, 'identificationModule': {'nctId': 'NCT03400592', 'acronym': 'NIEGA', 'briefTitle': 'Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Multi-center Phase II Trial of Nimotuzumab Plus Irinotecan in Patients With High EGFR Expression After Failure of First-line Treatment in Recurrent or Metastatic Gastric Adenocarcinoma（NIEGA）', 'orgStudyIdInfo': {'id': 'NIEGA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'irinotecan and nimotuzumab', 'description': 'Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly', 'interventionNames': ['Drug: Irinotecan', 'Drug: nimotuzumab']}], 'interventions': [{'name': 'Irinotecan', 'type': 'DRUG', 'description': '180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient', 'armGroupLabels': ['irinotecan and nimotuzumab']}, {'name': 'nimotuzumab', 'type': 'DRUG', 'description': '400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient', 'armGroupLabels': ['irinotecan and nimotuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lin shen, MD. PhD', 'role': 'CONTACT', 'email': 'linshenpku@163.com', 'phone': '(86)10-88196561'}, {'name': 'jifang gong, MD. PhD', 'role': 'CONTACT', 'email': 'gongjifang@gmail.com', 'phone': '(86)10-88196561'}], 'facility': 'Peking cancer hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of GI oncology, Beijing Cancer Hospital', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}