Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT05313906
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'RC48 plus AK105 and cisplatin'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'three months', 'description': 'the proportion of patients who got CR and PR'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'six months and twelve months', 'description': 'the duration of diseases stable or better'}, {'measure': 'DCR', 'timeFrame': 'three months', 'description': 'the proportion of patients who got CR, PR and SD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Gastric Carcinoma', 'HER2-positive Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.', 'detailedDescription': 'Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old, ≤75 years old, regardless gender\n* Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+\n* ECOG PS scores 0-1\n* Stage IV according to AJCC 8.0 and no systemic therapy previously\n* Expected lifespan ≥ 3 months\n* Adequate organ function\n* At least one measurable lesion according to RECIST 1.1\n* Asymptomatic intracranial metastasis\n* No history of other malignancies\n* Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial\n* Agreed to participate in this clinical study and signed the Informed Consent\n\nExclusion Criteria:\n\n* Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose\n* Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor\n* Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration\n* Active autoimmune diseases or immunodeficiency diseases\n* Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug\n* Severe mental disorder\n* Receiving systemic corticosteroids within 7 days prior to the first dose of the study\n* Clinically apparent cardiovascular and cerebrovascular disease\n* Others investigators evaluated not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05313906', 'briefTitle': 'RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'HenanCH immunotherapy007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exprimental group', 'description': 'RC48 plus AK105 and cisplatin', 'interventionNames': ['Drug: RC48+AK105+cisplatin']}], 'interventions': [{'name': 'RC48+AK105+cisplatin', 'type': 'DRUG', 'description': 'RC48 plus AK105 and cisplatin', 'armGroupLabels': ['exprimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Quanli Gao, Dr', 'role': 'CONTACT', 'email': 'zlyygql0855@zzu.edu.cn', 'phone': '+8637165587795'}], 'overallOfficials': [{'name': 'Quanli Gao, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Henan Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'The IPD will be shared with researhers who plan to do meta-analysis or other reasonable requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Rongchang Biopharmaceutical', 'class': 'UNKNOWN'}, {'name': 'Zhengda Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Quanli Gao', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}