Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-31 @ 6:57 PM
Study NCT ID:
NCT07009600
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversion Surgery After Target Therapy or Immunotherapy in Stage IV Gastric Cancer
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': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival and disease free survival', 'timeFrame': 'from date of surgery until the date of first documented cancer recurrence or date of death from cancer progression, whichever came first, assessed up to 160 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer Stage IV']}, 'descriptionModule': {'briefSummary': 'In this retrospective study, investigators conducted a comprehensive investigation of the factors influencing postoperative prognosis in patients with stage IV gastric cancer undergoing conversion surgery. Specifically, investigators examined the impact of targeted therapy or immune check point inhibitors (ICIs) in combination with preoperative chemotherapy on (1) prognostic differences based on initial progression (invading adjacent organs) and metastatic site (peritoneum, distant lymph node \\[LN\\]) at the time of stage IV gastric cancer diagnosis and (2) conversion surgery outcomes and pathological complete response (pCR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with clinically diagnosed and histologically confirmed stage IV gastric cancer between January 2010 and August 2024 and received systemic palliative-intent chemotherapy as initial treatment and underwent conversion surgery at Samsung Medical Center.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage IV gastric cancer patients who underwent conversion surgery\n\nExclusion Criteria:\n\n* Patients who did not undergo gastrectomy\n* Patients who underwent emergent surgery due to cancer perforation\n* Patients with missing medical records or information'}, 'identificationModule': {'nctId': 'NCT07009600', 'briefTitle': 'Conversion Surgery After Target Therapy or Immunotherapy in Stage IV Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Impact of Targeted Therapy and Immune Checkpoint Inhibitors on Prognosis and Surgical Outcomes in Conversion Surgery for Stage IV Gastric Cancer', 'orgStudyIdInfo': {'id': 'SMC 2025-03-046-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'immune check point inhibitors (PD-1 inhibitors), target therapy (trastuzumab)', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'Sung Eun Oh', 'investigatorAffiliation': 'Samsung Medical Center'}}}}