Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 6:18 AM
Study NCT ID:
NCT04387695
Status:
UNKNOWN
Last Update Posted:
2023-02-16
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
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': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS) rate', 'timeFrame': 'at 12 weeks after randomization', 'description': 'Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.'}], 'secondaryOutcomes': [{'measure': 'Radiologic response rate', 'timeFrame': 'at 12 weeks after randomization', 'description': "Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate."}, {'measure': 'Overall patient survival rate', 'timeFrame': 'up to 2 years after randomization', 'description': 'The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.'}, {'measure': 'Objective response rate', 'timeFrame': 'at 12 weeks and up to 2 years after randomization', 'description': "Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate."}, {'measure': 'Disease control rate', 'timeFrame': 'at 12 weeks and up to 2 years after randomization', 'description': "Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma,Portal Vein Tumor Thrombus', 'Radiation ,Sorafenib'], 'conditions': ['Unresectable Hepatocellular Carcinoma', 'Portal Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.', 'detailedDescription': 'HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Child-Pugh score ≤ 7\n* Performance status: ECOG score ≤ 2\n* HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017\n* the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline\n* No previous therapy for HCC\n* at least one measurable target lesion according to RECIST 1.1\n* Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3\n* Serum total bilirubin ≤ 2 x ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN\n* Creatinine ≤ 1.5 x ULN\n* No plan for pregnancy or breast feeding. Active contraception.\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib\n* Complete obstruction of hepatic outflow\n* Uncontrolled ascites of hepatic encephalopathy\n* Prior liver transplantation\n* Positive for human immunodeficiency virus (HIV)\n* Active gastric or duodenal ulcer\n* Other uncontrolled comorbidities or malignancy\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04387695', 'briefTitle': 'SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'HEPIC2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBRT + TACE + Sorafenib', 'description': 'SBRT sequential TACE combined with Sorafenib', 'interventionNames': ['Radiation: SBRT+TACE+Sorafenib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sorafenib', 'description': 'Sorafenib 800 mg/day orally', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'SBRT+TACE+Sorafenib', 'type': 'RADIATION', 'otherNames': ['Stereotactic Body Radiation Therapy'], 'description': 'SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later', 'armGroupLabels': ['SBRT + TACE + Sorafenib']}, {'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['Nexavar'], 'description': 'Sorafenib 800 mg/day orally', 'armGroupLabels': ['Sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun-hui Sun, MD,PH.D', 'role': 'CONTACT', 'email': '1307005@zju.edu.cn', 'phone': '+86-0571-87236815'}, {'name': 'Tan-yang Zhou, MD,PH.D', 'role': 'CONTACT', 'email': 'zhoutanyang@zju.edu.cn', 'phone': '+86-0571-87236812'}], 'facility': 'The First Affiliated Hospital, College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jun-hui Sun, MD,PH.D', 'role': 'CONTACT', 'email': '1307005@zju.edu.cn', 'phone': '+86-0571-87236815'}, {'name': 'Tan-yang Zhou, MD,PH.D', 'role': 'CONTACT', 'email': 'zhoutanyang@zju.edu.cn', 'phone': '+86-0571-87236812'}], 'overallOfficials': [{'name': 'Jun-hui Sun, MD,PH.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}