Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-02-06 @ 3:41 PM
Study NCT ID:
NCT05361161
Status:
UNKNOWN
Last Update Posted:
2022-05-24
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy evaluation', 'timeFrame': 'up to 3 years', 'description': 'Objective response rate (ORR): complete response (CR) + partial response (PR). Evaluation methods: Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria. Complete Remission (CR): All target and non-target lesions disappeared, no new lesions; Partial Remission (PR): Compared with baseline, tumor burden decreased by ≥30%, and non-target lesions did not progress significantly , no new lesions; Stable Disease (SD): neither PR nor PD; Progressive Disease (PD): tumor burden increased by ≥20%, and the absolute value increased by at least 5mm, or non-target lesions progressed, or new lesions (reconfirm progression after at least 6 weeks).'}, {'measure': 'Surgical resection rate', 'timeFrame': 'up to 3 years', 'description': 'Surgical resection rate: The rate of surgical resection is transformed from those who cannot undergo radical surgical resection and one-stage anastomosis after treatment.'}, {'measure': 'PFS', 'timeFrame': 'up to 3 years', 'description': 'Progression-free survival（PFS） is defined as the time between the date of randomization and any documented tumor progression or death from any cause.'}, {'measure': 'OS', 'timeFrame': 'up to 3 years', 'description': 'Overall survival (OS), defined as the time from study entry (ie, signing the ICF) to death from any cause. For subjects who were alive at the last contact, their overall survival was censored on the date of the last contact.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Embolization']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of Initial unresectable gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;\n2. Age (18-80 years old) and gender are not limited;\n3. No extragastric organ transfer;\n4. No serious diseases of the heart, liver, lung, kidney and other organs;\n5. Expected survival time \\> 3 months;\n6. Physical performance status score ECOG ≤1 point;\n7. Females of reproductive age must have a negative pregnancy test; or male and female patients must agree to use effective contraception during treatment and within 1 year thereafter.\n\nExclusion Criteria:\n\n1. Poor coagulation function, INR\\>1.5, or ongoing anticoagulation therapy or known bleeding diseases;\n2. WBC \\<3000/mm3 or platelet count \\<50000/mm3;\n3. AST and/or ALT \\> 3 times the upper limit of normal;\n4. Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;\n5. The patient has other primary tumors.'}, 'identificationModule': {'nctId': 'NCT05361161', 'briefTitle': 'Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)', 'orgStudyIdInfo': {'id': 'TACE-GC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer', 'interventionNames': ['Drug: Transarterial Chemoembolization']}], 'interventions': [{'name': 'Transarterial Chemoembolization', 'type': 'DRUG', 'description': 'Arterial infusion chemotherapy (THP + oxaliplatin + raltitrexed) and THP combined with lipiodol embolization for 2 times, with an interval of 1 month.', 'armGroupLabels': ['Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gang Wu, MD', 'role': 'CONTACT', 'email': 'wuganghenan2015@163.com', 'phone': '+86 13938570175'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gang Wu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Gang Wu', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}