Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:41 AM
Study NCT ID:
NCT07429318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Survival Analysis of Perioperative Treatment of Locally Advanced Gastric or Gastroesophageal Junction Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS', 'timeFrame': 'From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented death from any cause, assessed up to 100 months.', 'description': 'overall survival'}], 'secondaryOutcomes': [{'measure': 'EFS', 'timeFrame': 'From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 100 months.', 'description': 'event free survival'}, {'measure': 'DFS', 'timeFrame': 'From the start date of cycle 1 (each cycle is 14 days or 21 days) adjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.', 'description': 'disease free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, retrospective cohort study. The purpose is to evaluate different perioperative treatment options on the efficacy and survival prognosis of locally advanced GC/GEJC, clarify whether the tumor regression grade can influence survival of patients using neoadjuvant therapy. Moreover, we aim to explore the clinical and pathological characteristics that will affect the long-term survival benefit of patients who underwent perioperative treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who had locally advanced GC/GEJC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Pathologically diagnosed as gastric adenocarcinoma or esophageal-gastric junction adenocarcinoma, and has not received any anti-tumor treatment before (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)\n* (2) cT3-4N+M0 (according to AJCC version 8 stage) confirmed as resectable by CT or MRI.\n* (3) Patients who underwent adjuvant therapy before surgery.\n* (4) After neoadjuvant therapy , radical resection was performed at the Cancer Hospital of the Chinese Academy of Medical Sciences.\n* (5) Patients who have complete clinical, pathological and imaging data.\n\nExclusion Criteria:\n\n* (1) It is known that peritoneal metastasis or peritoneal irrigation solution cytology is positive (CY1P0) or there is distant metastasis (according to the 8th edition of AJCC).\n* (2) There are unresectable factors, including irresectable tumor causes or surgical contraindications that are irresectable or refuse surgery.\n* (3) Those who have suffered from other malignant tumors within 5 years or at the same time, except for cured skin basal cell carcinoma and cervical cancer in situ and breast cancer in situ.\n* (4) Those who have had radiotherapy, interventional treatment and other local therapists before surgery.\n* (5) Patients whose key diagnosis and treatment information records were missing.'}, 'identificationModule': {'nctId': 'NCT07429318', 'acronym': 'GC/GEJC', 'briefTitle': 'Efficacy and Survival Analysis of Perioperative Treatment of Locally Advanced Gastric or Gastroesophageal Junction Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Efficacy and Survival Prognosis Analysis of Perioperative Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': 'NCC5964'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chemotherapy', 'description': 'patients who only used chemotherapy during neoadjuvant treatment', 'interventionNames': ['Procedure: Chemo only']}, {'label': 'immunochemotherapy', 'description': 'patients who used immunotherapy combined with chemotherapy during neoadjuvant treatment', 'interventionNames': ['Procedure: Immunochemotherapy']}], 'interventions': [{'name': 'Chemo only', 'type': 'PROCEDURE', 'otherNames': ['chemothreapy'], 'description': 'Patients who only used chemotherapy during neodajuvant treatment period', 'armGroupLabels': ['chemotherapy']}, {'name': 'Immunochemotherapy', 'type': 'PROCEDURE', 'otherNames': ['immunotherapy combined with chemotherapy'], 'description': 'Patients who used immunotherapy combined with chemotherapy during neodajuvant treatment period', 'armGroupLabels': ['immunochemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'LIN YANG', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}