Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06001567
Status:
UNKNOWN
Last Update Posted:
2023-09-14
First Post:
2023-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533238', 'term': 'avatrombopag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with PLT >75×10^9/L or doubling from baseline', 'timeFrame': '1 year', 'description': 'The proportion of patients with PLT \\>75×10\\^9/L or doubling from baseline'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with PLT >75×10^9/L', 'timeFrame': '1 year', 'description': 'The proportion of patients with PLT \\>75×10\\^9/L'}, {'measure': 'Proportion of patients with PLT doubling from baseline', 'timeFrame': '1 year', 'description': 'The proportion of patients with PLT doubling from baseline'}, {'measure': 'Increace in PLT', 'timeFrame': '1 year', 'description': 'the Increace in PLT after treatment'}, {'measure': 'Proportion of patients who successfully receive TACE/HAIC', 'timeFrame': '1 year', 'description': 'The proportion of patients who successfully receive TACE/HAIC'}, {'measure': 'Adverse events (AEs)', 'timeFrame': '1 year', 'description': 'Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombocytopenia', 'Hepatocellular Carcinoma', 'Transarterial Chemoembolization', 'hepatic arterial infusion chemotherapy'], 'conditions': ['Thrombocytopenia', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in patients with hepatocellular carcinoma (HCC) who intend to undergo transarterial chemoembolization (TACE) and/or hepatic arterial infusion chemotherapy (HAIC).', 'detailedDescription': 'This is a single-center, prospective study to evaluate the efficacy of avatrombopag for thrombocytopenia in HCC patients who intend to undergo TACE and/or HAIC.\n\n30 HCC patients with thrombocytopenia will be enrolled in this study. Avatrombopag (platelet count \\[PLT\\] \\<40×10\\^9/L, 60mg P.O. QD; PLT of 40-75×10\\^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10\\^9/L, the treatment will be discontinued.\n\nThe primary end point of this study is the proportion of patients with PLT \\>75×10\\^9/L or doubling from baseline. The secondary endpoints are the proportion of patients with PLT \\>75×10\\^9/L, the proportion of patients with PLT doubling from baseline, the increace in PLT, the proportion of patients who successfully receive TACE/HAIC, .adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCC with diagnosis confirmed pathologically or clinically\n* Patients who need to receive TACE and/or HAIC, or have plans to undergo another treatment (3-6 weeks after the previous treatment)\n* Child Pugh class A or B\n* ECOG PS 0-2\n* PLT ≤ 75×10\\^9/L (10 days before interventional therapy)\n\nExclusion Criteria:\n\n* Thrombocytopenia caused by hematological diseases, non chemotherapy related thrombocytopenia (excluding liver cirrhosis with hypersplenism)\n* PLT \\<30×10\\^9/L\n* History of hepatic encephalopathy, refractory ascites, or hepatorenal syndrome\n* History of arterial or venous thrombosis within 6 months\n* Uncontrolled severe infections\n* Pregnant or breastfeeding female patients\n* Immune deficiencies, such as autoimmune diseases, HIV infected individuals, etc\n* Anticoagulation or antiplatelet therapy witch cannot be suspended during the treatment period: heparin, warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory drugs, aspirin, verapamil, Ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, erythropoietin, etc;\n* Administration of blood products within 7 days prior to the baseline visit (excluding albumin infusion)\n* Allergy to avatrombopag or any of its formulations\n* History (such as gastrointestinal bleeding within 3 months, high risk of thrombosis, such as portal vein main flow velocity\\<10cm/s) which may affect the safety of the patients or their ability to complete the study'}, 'identificationModule': {'nctId': 'NCT06001567', 'briefTitle': 'Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'A Single-center, Single-arm Study of Avatrombopag for Patients With Hepatocellular Carcinoma and Thrombocytopenia Who Intend to Undergo Transarterial Chemoembolization and/or Hepatic Arterial Infusion Chemotherapy', 'orgStudyIdInfo': {'id': 'MIIR-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avatrombopag', 'description': 'Patients receive avatrombopag treatment 5-10 days.', 'interventionNames': ['Drug: Avatrombopag']}], 'interventions': [{'name': 'Avatrombopag', 'type': 'DRUG', 'description': 'Avatrombopag (platelet count \\[PLT\\] \\<40×10\\^9/L, 60mg P.O. QD; PLT of 40-75×10\\^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10\\^9/L, the treatment will be discontinued.', 'armGroupLabels': ['Avatrombopag']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kangshun Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhksh010@126.com', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mingyue Cai, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Mingyue Cai, Dr.', 'role': 'CONTACT', 'email': 'cai020@yeah.net', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhksh010@163.com', 'phone': '+86-20-34156205'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}