Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06923020
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-11
First Post:
2025-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Nutritional Status With Immune Checkpoint Inhibitor Efficacy in Metastatic Metastatic Esophagogastric 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '5 years', 'description': 'Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '3 years', 'description': 'Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with EGC.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Neoplasm', 'Esophageal Adenosquamous Carcinoma']}, 'descriptionModule': {'briefSummary': 'In patients with advanced gastrointestinal cancers, malnutrition can lead to increased incidence of adverse events during the peri-chemoradiotherapy period, reduced treatment tolerance, lower completion rates of therapy, compromised efficacy and quality of life, and ultimately shortened survival. Currently, immunotherapy represented by PD-1 inhibitors has become a cornerstone in the treatment of advanced gastrointestinal cancers. Nutritional status plays a critical role in malignancies, with the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) score being particularly important for assessing nutritional conditions in cancer patients. Gastrointestinal cancers, as a group of heterogeneous tumors with distinct morphological and molecular genetic features, are closely linked to nutritional status. Peripheral blood cell profiles reflect the inflammatory impact of malignancies and immune responses in patients, which are crucial for determining treatment responses and clinical outcomes to enable early stratification, intervention, and monitoring. Therefore, this study aims to explore the clinical significance of nutrition-related prognostic indicators in immunotherapy by evaluating nutritional status and comparing treatment efficacy of first-line immune checkpoint inhibitors among advanced gastric cancer and esophageal cancer patients (including unresectable locally advanced, recurrent, or metastatic gastrointestinal cancers such as gastric/gastroesophageal junction adenocarcinoma and esophageal carcinoma) with different nutritional profiles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'metastatic ESCC and GC patients receiving the first-line therapy ICIs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed esophageal squamous carcinoma and gastric adenocarcinoma, metastatic disease.\n* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)\n* Karnofsky performance status ≥80\n* Life expectancy of ≥ 3 month\n* WBC \\> 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet \\> 100,000/mm3, Hb \\> 9g/dl(within 14 days before enrollment),ALT and AST \\< 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \\< 1.0 times ULN,Serum AKP \\< 2.5 times ULN,Serum creatinine \\< 1.5 times ULN\n* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \\> 38℃；\n* Normal ECG and heart function\n* Fertile patients must use effective contraception\n* Good compliance\n\nExclusion Criteria:\n\n* Previous treatment of palliative chemotherapy\n* Only with Brain or bone metastasis\n* No measurable lesions, eg. pleural fluid and ascites\n* Suffer from severe heart disease or disease with other important organs\n* Chronic diarrhea or renal dysfunction\n* Pregnancy or lactation period\n* Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea\n* Mentally abnormal or disable cognition,including CNS metastasis'}, 'identificationModule': {'nctId': 'NCT06923020', 'briefTitle': 'Association of Nutritional Status With Immune Checkpoint Inhibitor Efficacy in Metastatic Metastatic Esophagogastric Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'Exploring the Correlation Between Nutritional Status and Efficacy of First-Line Immune Checkpoint Inhibitors in Metastatic Esophagogastric Cancer: A Prospective Cohort Study.(Nutrition EGC)', 'orgStudyIdInfo': {'id': 'Nutrition EGC-2024-KY-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'advanced GC patients receiving first-line ICIs', 'interventionNames': ['Other: Exposure: Nutritional Status']}, {'label': 'Cohort B', 'description': 'advanced ESCC patients receiving first-line ICIs', 'interventionNames': ['Other: Exposure: Nutritional Status']}], 'interventions': [{'name': 'Exposure: Nutritional Status', 'type': 'OTHER', 'description': 'The assessment of nutritional risk screening (NRS) and nutritional assessments were conducted using NRS 2002 and Patient-Generated Subjective Global Assessment (PG-SGA).', 'armGroupLabels': ['Cohort A']}, {'name': 'Exposure: Nutritional Status', 'type': 'OTHER', 'description': 'The assessment of nutritional risk screening (NRS) and nutritional assessments were conducted using NRS 2002 and Patient-Generated Subjective Global Assessment (PG-SGA).', 'armGroupLabels': ['Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Yongxu Jia', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yongxu Jia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The First Affiliated Hospital of Zhengzhou University', 'investigatorFullName': 'Yongxu Jia', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}