Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 11:28 AM
Study NCT ID:
NCT05001360
Status:
WITHDRAWN
Last Update Posted:
2021-10-27
First Post:
2021-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of FMT Combined With Nivolumab in Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'We could not get the IRB approval.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'OS', 'timeFrame': 'up to 2 years', 'description': 'Overall survival defined as the time from enrollment to death from any cause'}], 'primaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': '24 weeks', 'description': 'iCR + iPR + iSD rate according to iRECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': '6, 12, 18 weeks', 'description': 'iCR + iPR + iSD rate according to iRECIST criteria'}, {'measure': 'Objective response rate', 'timeFrame': '24 weeks', 'description': 'iCR + iPR rate according to iRECIST criteria'}, {'measure': 'Changes of intestinal microbiota characteristics between responders and non-responders', 'timeFrame': '24 weeks', 'description': 'To compare the change of intestinal microbiota characteristics between responders and non-responders'}, {'measure': 'Changes of related immune cells in peripheral blood between responders and non-responders', 'timeFrame': '12 weeks', 'description': 'To compare the change of related immune cells in peripheral blood between responders and non-responders'}, {'measure': 'Change of CD8+T cell counts in tumor tissue between responders and non-responders', 'timeFrame': '6 weeks', 'description': 'To compare the change of CD8+T cell counts in tumor tissue between responders and non-responders'}, {'measure': 'Change of CD8+T cell counts in intestinal tissue between responders and non-responders', 'timeFrame': '6 weeks', 'description': 'To compare the change of CD8+T cell counts in intestinal tissue between responders and non-responders'}, {'measure': 'Incidence and severity of AEs that related to XBI-302', 'timeFrame': '24 weeks', 'description': 'Rate of adverse events and their severity that are determined to be related to XBI-302'}, {'measure': 'Incidence and severity of immune related AEs', 'timeFrame': '24 weeks', 'description': 'Rate and severity of irAEs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma', 'Esophagogastric Junction Adenocarcinoma', 'Esophagus Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a single-arm, single center study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.', 'detailedDescription': 'The primary purpose of this single-arm, open-label, single center trial is to evaluate the efficacy and safety of XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.\n\nDuring treatment period, all eligible subjects will receive XBI-302 with Nivolumab following gut preparation. The imaging evaluation of efficacy will be performed every 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily participate in this study and provide written informed consent\n* Age ≥ 18 years and ≤70 years, male or female\n* Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies\n* Able and willing to provide tumor tissue\n* At least one measurable extracranial target lesion according to iRECIST\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy ≥3 months\n\nExclusion Criteria:\n\n* History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin\n* Had systemic diseases that were difficult to control within 4 weeks prior to screening\n* History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy\n* History of coagulation disorders\n* Mechanical or paralytic obstruction of the gastrointestinal tract\n* Anticipated to receive a great number of antibiotics during study period'}, 'identificationModule': {'nctId': 'NCT05001360', 'briefTitle': 'Study of FMT Combined With Nivolumab in Gastric Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer', 'orgStudyIdInfo': {'id': 'SYLT-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XBI-302 + Nivolumab', 'description': 'FMT capsules XBI-302 will be administered orally every two weeks for 12 weeks and then every four weeks for 12 weeks. Nivolumab will be intravenously infused every two weeks for 24 weeks.', 'interventionNames': ['Drug: XBI-302 + Nivolumab']}], 'interventions': [{'name': 'XBI-302 + Nivolumab', 'type': 'DRUG', 'otherNames': ['FMT + PD-1 inhibitor'], 'description': 'After gut preparation, a single dose of FMT will be performed via oral administration. Subsequently, nine combined treatment cycles that composed of anti-PD-1 infusions (Nivolumab at 240 mg, q2w) and additional FMT capsules, and 3 single treatment cycles of anti-PD-1 infusions will be administered.', 'armGroupLabels': ['XBI-302 + Nivolumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}