Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-01 @ 8:13 AM
Study NCT ID:
NCT05862259
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Indicators of cardiac injury', 'timeFrame': 'two years', 'description': 'Including but not limited to troponin, BNP and cardiac magnetic resonance imaging'}], 'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'six months', 'description': 'The time between randomization and the first occurrence of disease progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'two years', 'description': 'Time from randomization to death from any cause'}, {'measure': 'Objective response rate', 'timeFrame': 'one years', 'description': 'Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements'}, {'measure': 'Immune-Related Adverse Events', 'timeFrame': 'two years', 'description': 'In clinical trials of antineoplastic drugs/therapies, all levels of adverse drug reactions that are judged to be related to immune mechanisms,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Tumor', 'Immunotherapy', 'Artificial Intelligence']}, 'descriptionModule': {'briefSummary': 'In this study, we collected the data of immunohistochemistry, gene detection, image, OS, PFS, Orr, and so on. Secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'receiving immunotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.\n2. the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology.\n3. the stage IV according to the eighth edition of IASLC.\n4. PS 0-2, the expected survival \\> 3 months.\n5. the age of 18-75 years.\n6. no contraindication to treatment with immune checkpoint inhibitors.\n\nExclusion Criteria:\n\n1. the patients' compliance was poor, which violated the rules of the trial;\n2. the patients with severe dysfunction of vital organs (heart, liver and kidney) ;\n3. the patients with other malignant tumors;\n4. the researchers considered that the patients should not participate in other conditions of the trial."}, 'identificationModule': {'nctId': 'NCT05862259', 'briefTitle': 'A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'A Multicenter, Multiomics, Non-interventional, Real-world Study of the Efficacy and Safety of Immune Checkpoint Inhibitors as First-line Therapy for Advanced Malignancies', 'orgStudyIdInfo': {'id': 'XQonc-021'}}, 'contactsLocationsModule': {'locations': [{'zip': '40037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianguo sun, Phd', 'role': 'CONTACT', 'email': 'sunjg09@aliyun.com', 'phone': '023-68774490'}], 'facility': 'the second affiliated hospital of Army medical university', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director of oncology department，clinical professor', 'investigatorFullName': 'Jianguo Sun', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}