Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-02 @ 10:27 PM
Study NCT ID:
NCT03259867
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2017-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of TATE and PD-1 Inhibitor in Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One arm for advanced HCC, and one for second line metastatic gastro-esophageal cancer . All enrolled patients will receive the same treatment with TATE and a PD-1 inhibitor (nivolumab) until disease progression'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'up to 24 months', 'description': 'Per RECIST 1.1 criteria'}], 'secondaryOutcomes': [{'measure': 'Duration of Response', 'timeFrame': 'up to 24 months', 'description': 'From the date of image-demonstrated response to the date of progression'}, {'measure': 'Time to Progression', 'timeFrame': 'up to 24 months', 'description': 'From randomization to disease progression or death'}, {'measure': 'Progression Free Survival', 'timeFrame': 'up to 24 months', 'description': 'From randomization to disease progression or death'}, {'measure': 'Overall survival', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'From randomization to death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Immune checkpoint inhibitor', 'Gastric cancer', 'Progression'], 'conditions': ['Hepatocellular Carcinoma', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '35504436', 'type': 'BACKGROUND', 'citation': 'Liu CH, Peng CM, Hwang JI, Liang PC, Chen PJ, Abi-Jaoudeh N, Giiang LH, Tyan YS. Phase I Dose-Escalation Study of Tirapazamine Chemoembolization for Unresectable Early- and Intermediate-Stage Hepatocellular Carcinoma. J Vasc Interv Radiol. 2022 Aug;33(8):926-933.e1. doi: 10.1016/j.jvir.2022.04.031. Epub 2022 Apr 30.'}, {'pmid': '34041204', 'type': 'BACKGROUND', 'citation': 'Abi-Jaoudeh N, Dayyani F, Chen PJ, Fernando D, Fidelman N, Javan H, Liang PC, Hwang JI, Imagawa DK. Phase I Trial on Arterial Embolization with Hypoxia Activated Tirapazamine for Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2021 May 17;8:421-434. doi: 10.2147/JHC.S304275. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label phase IIA study that investigates the preliminary efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer followed by a PD-1 checkpoint inhibitor (nivolumab). Patients with two types of cancers will be enrolled, advanced hepatocellular carcinoma (HCC),and metastatic gastric cancer. All enrolled patients need to have liver lesions and have progressed on a prior immune checkpoint inhibitor.', 'detailedDescription': 'The goal of the study is to investigate whether tumor necrosis induced by Trans-arterial Tirapazamine Embolization (TATE) treatment can boost anti-tumor immunity and enhance the therapeutic efficacy of immune checkpoint inhibitor. Patients with advanced liver cancers (primary HCC or metastatic gastric cancer) who have progressed on a prior immune checkpoint inhibitor will be enrolled in the study. Liver lesions will be treated with up to 4 TATE treatments for optimal debulking, which also serve as a vaccination process toward tumor. Lesion not treated with TATE will be used for monitoring the response toward a PD-1 inhibitor (Nivolumab) for abscopal effect. If a patient subsequently develops an "escape" to the PD-1 inhibitor, patient can have another 2 TATE treatments of the escaped tumor lesion. Dosing of the PD-1 inhibitor is per standard FDA-approved dosing schedule and continues until progressive disease. The efficacy will be assessed by the response rate (RR) using RECIST.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.\n2. Patients between ages 18 and 80\n3. If HCC patients, they should have progressive disease (PD) on an immune therapy for advanced HCC. For patients with metastatic gastric cancer, they should have failed at least one line of systemic chemotherapy and an immune checkpoint inhibitor.\n4. Patients with liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target lesion.\n5. ECOG score 2 or less\n6. Child-Pugh scores 5-7 for HCC patients\n7. All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not subject to this limitation.\n8. No major GI bleeding in the prior 2 months.\n\n8\\. Hgb\\>=8, platelet \\>= 50,000, Cr =\\< 2, AST and ALT \\< 10 X ULN, t-Bilirubin \\< 3, 9. Patients with a history of major autoimmune disorders excluded.'}, 'identificationModule': {'nctId': 'NCT03259867', 'acronym': 'TATE-PD1', 'briefTitle': 'Combination of TATE and PD-1 Inhibitor in Liver Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teclison Ltd.'}, 'officialTitle': 'Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody', 'orgStudyIdInfo': {'id': 'LT-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced Hepatocellular carcinoma', 'description': 'PD-1 inhibitor (Nivolumab 360 mg Q3W IV ) starts at day 1, and continues until progression.\n\nTATE treatment starts at day 8 for debulking up to 4 cycles. If escape lesion appears, two more TATE treatments can be given. Tirapazamine dose at 35 mg flat dose given before embolization.', 'interventionNames': ['Drug: Nivolumab Injectable Product', 'Combination Product: Trans-arterial tirapazamine embolization']}, {'type': 'EXPERIMENTAL', 'label': 'Metastatic Gastro-esophageal cancer', 'description': 'PD-1 inhibitor (Nivolumab 360 mg Q3W IV) starts at day 1, and continues until progression.\n\nTATE treatment starts at day 8 for debulking up to 4 cycles. If escape lesion appears, two more TATE treatments can be given. Tirapazamine dose at 35 mg flat dose given before embolization.', 'interventionNames': ['Drug: Nivolumab Injectable Product', 'Combination Product: Trans-arterial tirapazamine embolization']}], 'interventions': [{'name': 'Nivolumab Injectable Product', 'type': 'DRUG', 'otherNames': ['OPDIVO'], 'description': 'a PD-1 immune check inhibitor', 'armGroupLabels': ['Advanced Hepatocellular carcinoma', 'Metastatic Gastro-esophageal cancer']}, {'name': 'Trans-arterial tirapazamine embolization', 'type': 'COMBINATION_PRODUCT', 'description': 'Embolization with Lipiodol and Gelfoam', 'armGroupLabels': ['Advanced Hepatocellular carcinoma', 'Metastatic Gastro-esophageal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Miranda Duron', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'mnduron@hs.uci.edu'}, {'name': 'Nadine Abi-Jaoudeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Yarbrough, RN', 'role': 'CONTACT', 'email': 'melissa-yarbrough@ouhsc.edu'}], 'facility': 'University of Oklahoma Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Dion', 'role': 'CONTACT', 'email': 'badion@mcw.edu'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Ray Lee, MD. PhD', 'role': 'CONTACT', 'email': 'ray.lee01@teclison.com', 'phone': '8043341076'}, {'name': 'Chiwei Lu, PhD.', 'role': 'CONTACT', 'email': 'chiwei.lu4@teclison.com'}], 'overallOfficials': [{'name': 'Nadine Abi-Jaoudeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Irvine Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teclison Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}