Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-27 @ 6:38 PM
Study NCT ID:
NCT05262959
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2022-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710249', 'term': 'donafenib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-11', 'studyFirstSubmitDate': '2022-02-20', 'studyFirstSubmitQcDate': '2022-02-20', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival 1(PFS 1)', 'timeFrame': 'an average of 1 year', 'description': 'PFS 1 refers to the time from the date of enrollment to the first documented tumor progression as assessed by mRECIST criteria or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) per mRECIST', 'timeFrame': 'an average of 1 year', 'description': 'The proportion of patients exhibiting a complete response or partial response to treatment, as assessed by mRECIST.'}, {'measure': 'Disease control rate (DCR) per mRECIST', 'timeFrame': 'an average of 1 year', 'description': 'The proportion of patients exhibiting a complete response, partial response or stable disease, as assessed by mRECIST.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'an average of 1.5 year', 'description': 'The time from the date of enrollment to the date of death from any cause.'}, {'measure': 'Adverse events and serious adverse events.', 'timeFrame': 'an average of 1.5 year.', 'description': 'Incidence of adverse events and serious adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Donafenib', 'Hepatocellular Carcinoma'], 'conditions': ['Donafenib']}, 'descriptionModule': {'briefSummary': 'This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients voluntarily enter the study and sign informed consent form (ICF);\n2. Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender;\n3. Clinically or histologically diagnosed as unresectable HCC;\n4. There is at least one measurable lesions that meet the mRECIST standard;\n5. Child-pugh classification A or B (score≤7);\n6. ECOG : 0 \\~ 1 ;\n7. The number of intrahepatic tumors ≤ 10 and the maximum tumor diameter ≤ 10cm;\n8. Previous TACE treatment ≤ 1 time;\n9. Life expectancy ≥ 3 months;\n10. For patients with HBV infection, if HBV-DNA is≥10\\^4copies/ml within 14 days before enrollment, they should take antiviral treatment first, reduce 1 log or reduce to \\<10\\^4copies/ml before entering the study, and continue antiviral treatment and monitor liver function and serum HBV-DNA levels;\n11. Baseline blood routine and biochemical indexes meet the following criteria within 14 days before treatment:\n\n Blood routine examination criteria must be met: (no blood transfusion within 14 days)\n 1. HB≥90g/L；\n 2. ANC≥1.5×10\\^9/L；\n 3. PLT≥70×10\\^9/L.\n\n Biochemical tests are subject to the following criteria:\n 1. BIL \\<1.25xULN ；\n 2. ALT and AST\\<5xULN；\n 3. Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance\\>50ml/min ( Cockcroft-Gault formula)；\n 4. Albumin≥28g/L；\n 5. Electrolytes (phosphorus, calcium, magnesium, potassium) ≥ LLN;\n 6. Urine protein \\<2+ or 24-hour urine protein quantitative detection ≤1.0 g/L.\n\n Blood coagulation indexes are subject to the following criteria:\n 1. Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;\n 2. Activated partial thromboplastin time（APTT）≤1.5 × ULN.\n12. The serum pregnancy test results of female patients with fertility (referring to premenopausal or non surgical sterilization) must be negative within 14 days before enrollment.\n\nExclusion Criteria:\n\n1. Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma;\n2. The presence of a tumor thrombus in the main portal vein, biliary tract tumor thrombus, inferior vena cava tumor thrombus, or extrahepatic metastasis;\n3. Hepatocellular carcinoma recurrence within 2 years after radical resection or ablation;\n4. History of malignancy other than HCC within 5 years;\n5. Esophageal and/or gastric varices bleeding within 4 weeks prior to initiation of study treatment;\n6. Presence of uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion;\n7. Patients who received liver transplant surgery, prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or palliative local treatment ≥2 times for HCC；\n8. History of organ and cell transplantation；\n9. TACE contraindications identified by the investigator;\n10. Active severe infection;\n11. Autoimmune disease or immune deficiency;\n12. Severe organ (heart, kidney) dysfunction;\n13. Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;\n14. Unable to follow the research protocol for treatment or scheduled follow-up; Any other researcher who thinks they cannot be included.'}, 'identificationModule': {'nctId': 'NCT05262959', 'briefTitle': 'A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Single Center Study of Donafenib Combined With Programmed Cell Death-1 （PD-1） + Transarterial Chemoembolization (TACE) in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC)', 'orgStudyIdInfo': {'id': 'B2021-631R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donafenib', 'description': 'Donafenib: 0.1g po. BID. And it will be taken on the first day of the study. PD-1: 200mg ivgtt. Q3W. It will be used at the same time as Donafenib. TACE: The first treatment will be carried out 2-3 weeks after taking Donafenib.', 'interventionNames': ['Drug: Donafenib, PD-1', 'Procedure: TACE']}], 'interventions': [{'name': 'Donafenib, PD-1', 'type': 'DRUG', 'description': 'Eligible subjects will receive Donafenib combined with PD-1 and TACE. Donafenib will be taken orally twice a day, 0.1mg each time.PD-1 will be used intravenously every 3 weeks.', 'armGroupLabels': ['Donafenib']}, {'name': 'TACE', 'type': 'PROCEDURE', 'description': "TACE will be performed by the investigator based on the patient's tumor status.", 'armGroupLabels': ['Donafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University,', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jian Zhou, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'name': 'Zhiping Yan, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}