Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-19 @ 10:30 PM
Study NCT ID:
NCT06649292
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 524}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-10-17', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Until death, assessed up to approximately 2 years', 'description': 'Measure description: Defined as time from randomization until the date of death due to any cause'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS) by investigator assessment', 'timeFrame': 'Until progression or death, assessed up to approximately 1 year', 'description': 'Measure description: Defined as time from randomization until progression or death as assessed by the investigator'}, {'measure': 'Objective response rate (ORR) by investigator assessment', 'timeFrame': 'Until progression, assessed up to approximately 1 year', 'description': 'Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator'}, {'measure': 'Duration of response (DOR) by investigator assessment', 'timeFrame': 'Until progression or death, assessed up to approximately 1 year', 'description': 'Measure description: Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator'}, {'measure': 'Disease control rate (DCR) by investigator assessment', 'timeFrame': 'Until progression, assessed up to approximately 1 year', 'description': 'Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator'}, {'measure': 'Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)', 'timeFrame': 'until to 90 days after the last dose，assessed up to approximately 2 years', 'description': 'Measure description: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 75 years old (including boundary values)\n2. Volunteer to participate in this clinical study and sign informed consent;\n3. ECOG score 0-1;\n4. Expected survival ≥3 months;\n5. Gastric or Gastroesophageal Junction Adenocarcinoma;\n6. positive CLDN18.2 expression in tumor tissue;\n7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;\n8. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study\n2. HER2 posotive (IHC 3+ or IHC 2+/ISH +);\n3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;\n4. Individuals with Leptomeningeal metastasis or Active brain metastases;\n5. Individuals with a history of GI perforation or fistula, unstable GI bleeding;\n6. Individuals with a history of severe cardiovascular and cerebrovascular diseases;\n7. The researcher determined that there are other situations that are not suitable for participation.'}, 'identificationModule': {'nctId': 'NCT06649292', 'briefTitle': "SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': "An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma", 'orgStudyIdInfo': {'id': 'SHR-A1904-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A: SHR-A1904', 'interventionNames': ['Drug: SHR-A1904']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group B: Paclitaxel, Docetaxel, Irinotecan.', 'interventionNames': ['Drug: Paclitaxel, Docetaxel, Irinotecan']}], 'interventions': [{'name': 'SHR-A1904', 'type': 'DRUG', 'description': 'SHR-A1904', 'armGroupLabels': ['Treatment group A: SHR-A1904']}, {'name': 'Paclitaxel, Docetaxel, Irinotecan', 'type': 'DRUG', 'description': 'Paclitaxel, Docetaxel, Irinotecan', 'armGroupLabels': ['Treatment group B: Paclitaxel, Docetaxel, Irinotecan.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruihua Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qi Shi', 'role': 'CONTACT', 'email': 'shi.qi.qs16@hengrui.com', 'phone': '86-021-23511999'}, {'name': 'Liang Hu', 'role': 'CONTACT', 'email': 'Liang.hu@hengrui.com', 'phone': '18036618148'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}