Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 4:08 PM
Study NCT ID:
NCT03009461
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2017-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC with Major Portal Vein Tumor Thrombosis
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': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-03', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Portal vein tumor thrombosis', 'Hepatic arterial infusion chemotherapy', 'Sorafenib'], 'conditions': ['HepatoCellular Carcinoma', 'Portal Vein Thrombosis']}, 'referencesModule': {'references': [{'pmid': '25862889', 'type': 'BACKGROUND', 'citation': 'Nagai H, Mukozu T, Ogino YU, Matsui D, Matsui T, Wakui N, Momiyama K, Igarashi Y, Sumino Y, Higai K. Sorafenib and hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombus. Anticancer Res. 2015 Apr;35(4):2269-77.'}, {'pmid': '14573429', 'type': 'BACKGROUND', 'citation': 'Sumie S, Yamashita F, Ando E, Tanaka M, Yano Y, Fukumori K, Sata M. Interventional radiology for advanced hepatocellular carcinoma: comparison of hepatic artery infusion chemotherapy and transcatheter arterial lipiodol chemoembolization. AJR Am J Roentgenol. 2003 Nov;181(5):1327-34. doi: 10.2214/ajr.181.5.1811327.'}, {'pmid': '21415578', 'type': 'BACKGROUND', 'citation': 'Kim HY, Kim JD, Bae SH, Park JY, Han KH, Woo HY, Choi JY, Yoon SK, Jang BK, Hwang JS, Kim SG, Kim YS, Seo YS, Yim HJ, Um SH; Korean Liver Cancer Study Group. A comparative study of high-dose hepatic arterial infusion chemotherapy and transarterial chemoembolization using doxorubicin for intractable, advanced hepatocellular carcinoma. Korean J Hepatol. 2010 Dec;16(4):355-61. doi: 10.3350/kjhep.2010.16.4.355.'}, {'pmid': '24008659', 'type': 'BACKGROUND', 'citation': 'Nouso K, Miyahara K, Uchida D, Kuwaki K, Izumi N, Omata M, Ichida T, Kudo M, Ku Y, Kokudo N, Sakamoto M, Nakashima O, Takayama T, Matsui O, Matsuyama Y, Yamamoto K; Liver Cancer Study Group of Japan. Effect of hepatic arterial infusion chemotherapy of 5-fluorouracil and cisplatin for advanced hepatocellular carcinoma in the Nationwide Survey of Primary Liver Cancer in Japan. Br J Cancer. 2013 Oct 1;109(7):1904-7. doi: 10.1038/bjc.2013.542. Epub 2013 Sep 5.'}, {'pmid': '21166003', 'type': 'BACKGROUND', 'citation': "Kingham TP, D'Angelica M, Kemeny NE. Role of intra-arterial hepatic chemotherapy in the treatment of colorectal cancer metastases. J Surg Oncol. 2010 Dec 15;102(8):988-95. doi: 10.1002/jso.21753."}, {'pmid': '24760444', 'type': 'BACKGROUND', 'citation': 'Xing M, Kooby DA, El-Rayes BF, Kokabi N, Camacho JC, Kim HS. Locoregional therapies for metastatic colorectal carcinoma to the liver--an evidence-based review. J Surg Oncol. 2014 Aug;110(2):182-96. doi: 10.1002/jso.23619. Epub 2014 Apr 24.'}, {'pmid': '26652741', 'type': 'BACKGROUND', 'citation': 'Cho M, Gong J, Fakih M. The state of regional therapy in the management of metastatic colorectal cancer to the liver. Expert Rev Anticancer Ther. 2016;16(2):229-45. doi: 10.1586/14737140.2016.1129277. Epub 2016 Jan 13.'}, {'pmid': '24664624', 'type': 'BACKGROUND', 'citation': "Konstantinidis IT, Do RK, Gultekin DH, Gonen M, Schwartz LH, Fong Y, Allen PJ, D'Angelica MI, DeMatteo RP, Klimstra DS, Kemeny NE, Jarnagin WR. Regional chemotherapy for unresectable intrahepatic cholangiocarcinoma: a potential role for dynamic magnetic resonance imaging as an imaging biomarker and a survival update from two prospective clinical trials. Ann Surg Oncol. 2014 Aug;21(8):2675-83. doi: 10.1245/s10434-014-3649-y. Epub 2014 Mar 25."}, {'pmid': '27820684', 'type': 'BACKGROUND', 'citation': 'Wang X, Hu J, Cao G, Zhu X, Cui Y, Ji X, Li X, Yang R, Chen H, Xu H, Liu P, Li J, Li J, Hao C, Xing B, Shen L. Phase II Study of Hepatic Arterial Infusion Chemotherapy with Oxaliplatin and 5-Fluorouracil for Advanced Perihilar Cholangiocarcinoma. Radiology. 2017 May;283(2):580-589. doi: 10.1148/radiol.2016160572. Epub 2016 Nov 7.'}, {'pmid': '23591833', 'type': 'BACKGROUND', 'citation': 'Katagiri S, Yamamoto M. Multidisciplinary treatments for hepatocellular carcinoma with major portal vein tumor thrombus. Surg Today. 2014 Feb;44(2):219-26. doi: 10.1007/s00595-013-0585-6. Epub 2013 Apr 17.'}, {'pmid': '24886354', 'type': 'BACKGROUND', 'citation': 'Nakazawa T, Hidaka H, Shibuya A, Okuwaki Y, Tanaka Y, Takada J, Minamino T, Watanabe M, Kokubu S, Koizumi W. Overall survival in response to sorafenib versus radiotherapy in unresectable hepatocellular carcinoma with major portal vein tumor thrombosis: propensity score analysis. BMC Gastroenterol. 2014 May 3;14:84. doi: 10.1186/1471-230X-14-84.'}, {'pmid': '18650514', 'type': 'BACKGROUND', 'citation': 'Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.'}, {'pmid': '19095497', 'type': 'BACKGROUND', 'citation': 'Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.'}, {'pmid': '24708192', 'type': 'BACKGROUND', 'citation': 'Zhu K, Chen J, Lai L, Meng X, Zhou B, Huang W, Cai M, Shan H. Hepatocellular carcinoma with portal vein tumor thrombus: treatment with transarterial chemoembolization combined with sorafenib--a retrospective controlled study. Radiology. 2014 Jul;272(1):284-93. doi: 10.1148/radiol.14131946. Epub 2014 Apr 6.'}, {'pmid': '9862851', 'type': 'BACKGROUND', 'citation': 'Llovet JM, Bustamante J, Castells A, Vilana R, Ayuso Mdel C, Sala M, Bru C, Rodes J, Bruix J. Natural history of untreated nonsurgical hepatocellular carcinoma: rationale for the design and evaluation of therapeutic trials. Hepatology. 1999 Jan;29(1):62-7. doi: 10.1002/hep.510290145.'}, {'pmid': '26026424', 'type': 'BACKGROUND', 'citation': 'Zhang ZM, Lai EC, Zhang C, Yu HW, Liu Z, Wan BJ, Liu LM, Tian ZH, Deng H, Sun QH, Chen XP. The strategies for treating primary hepatocellular carcinoma with portal vein tumor thrombus. Int J Surg. 2015 Aug;20:8-16. doi: 10.1016/j.ijsu.2015.05.009. Epub 2015 May 27.'}, {'pmid': '25651787', 'type': 'BACKGROUND', 'citation': 'Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.'}, {'pmid': '35103539', 'type': 'DERIVED', 'citation': 'Zheng K, Zhu X, Fu S, Cao G, Li WQ, Xu L, Chen H, Wu D, Yang R, Wang K, Liu W, Wang H, Bao Q, Liu M, Hao C, Shen L, Xing B, Wang X. Sorafenib Plus Hepatic Arterial Infusion Chemotherapy versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis: A Randomized Trial. Radiology. 2022 May;303(2):455-464. doi: 10.1148/radiol.211545. Epub 2022 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT), but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. There is no established standard treatment for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient must have histologically or clinically confirmed hepatocellular carcinoma.\n* HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein)\n* Child A class\n* Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =\\< 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,500/mcL\n* Platelets \\>= 100,000/mcL\n* Hemoglobin \\>= 90g/L\n* Total bilirubin =\\< 2 X institutional upper limit of normal\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \\[SGPT\\]) =\\< 2.5 X institutional upper limit of normality\n* Creatinine =\\< 1.5 X institutional upper limit of normal\n* Albumin \\>= 30g/L\n* Patient must be able to understand and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients who have had prior chemotherapy with Oxaliplatin or Fluorouracil or sorafenib.\n* Patient who is receiving any other investigational agents\n* Patient who have a diagnosis of hepatic encephalopathy\n* Patients who have a diagnosis of sclerosing cholangitis.\n* Patients who have a diagnosis of Gilbert's disease.\n* Patients who have clinical ascites\n* Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements\n* No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years\n* Patient who is pregnant or lactating\n* Patient Allergic to Iodine contrast medium\n* Uncontrolled severe coagulation disorders (INR \\< 1.5 in patients not on warfarin therapy)"}, 'identificationModule': {'nctId': 'NCT03009461', 'briefTitle': 'Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC with Major Portal Vein Tumor Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion with Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis', 'orgStudyIdInfo': {'id': 'MPVTT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sor-HAIC group', 'description': '400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.', 'interventionNames': ['Procedure: HAIC', 'Drug: Sorafenib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sor group', 'description': '400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'HAIC', 'type': 'PROCEDURE', 'description': 'Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.', 'armGroupLabels': ['Sor-HAIC group']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': '400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.', 'armGroupLabels': ['Sor group', 'Sor-HAIC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician, Associate Professor', 'investigatorFullName': 'Xiaodong Wang, MD', 'investigatorAffiliation': 'Peking University'}}}}