Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-01-27 @ 1:43 PM
Study NCT ID:
NCT02959359
Status:
WITHDRAWN
Last Update Posted:
2017-08-07
First Post:
2016-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DAA in the Risk of Recurrence After Curative Treatment of HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D012008', 'term': 'Recurrence'}], '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': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586541', 'term': 'ledipasvir'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The supplies of study drug were halted by Gilead Sciences Ltd.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-04', 'studyFirstSubmitDate': '2016-10-30', 'studyFirstSubmitQcDate': '2016-11-06', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years.', 'timeFrame': 'up to 5 years', 'description': 'The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years.'}], 'secondaryOutcomes': [{'measure': 'SVR 4/12/24 by DAA', 'timeFrame': 'up to 5 years', 'description': 'SVR: sustained virological response. DAA: direct antiviral agent. SVR 4/12/24 means undetectable HCV viral load 4/12/24 weeks after completing DAA treatment.'}, {'measure': 'Regression of fibrosis', 'timeFrame': 'up to 5 years', 'description': 'Regression of fibrosis'}, {'measure': 'Incidence of liver-related complications (EV bleeding, ascites) after DAA treatment', 'timeFrame': 'up to 5 years', 'description': 'Incidence of liver-related complications (EV bleeding, ascites) after DAA treatment'}, {'measure': 'Overall survival', 'timeFrame': 'up to 5 years', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic hepatitis C', 'Hepatocellular Carcinoma', 'Direct-acting antiviral (DAA)', 'Recurrence'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'For early stage of HCC, surgical resection or radiofrequency ablation (RFA) is the mainstay curative treatments. However, recurrence is still a major issue after the surgery or RFA. Only selected patients are eligible and tolerable to IFN-based treatment after surgical resection and the sustained virological response varied.\n\nHarvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR and being recommended by AASLD and EASL. Mixed HCV genotype infection accounts for 10% of CHC patients in Taiwan. Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi plus rivavirin in the treatment of genotype 2 HCV, as well as mixed genotype 1 and 2 HCV infection. As genotype 1 and 2 are the leading HCV genotypes in Taiwan, It can simplify the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin, not only for genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection. Although an unexpected high recurrence rate in HCC patients under DAA treatment was reported once. However, one recent study showed a low risk of HCC recurrence after DAA treatment. In this study, the investigators plan to enroll 130 HCV-HCC patients after confirming curative treatment for their HCC, either by surgery or RFA. For the cases fulfilling the inclusion/exclusion criteria, a 12 weeks Harvoni plus ribavirin treatment will be provided for all cases (single armed design). The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years. A hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei Veterans General Hospital and Investigated Sites will be recruited as historical controls.', 'detailedDescription': 'Chronic hepatitis C virus (HCV) infection is a major etiology of hepatocellular carcinoma (HCC). For early stage of HCC, surgical resection or radiofrequency ablation (RFA) is the mainstay curative treatments. However, recurrence is still a major issue after the surgery or RFA. According to our previous report, the cumulated recurrence rate for small HCV-HCC was 72.4% at 5 year. PEG-interferon plus RBV treatment is the standard of care for chronic hepatitis C (CHC) in Taiwan. NHIRD data showed that PEG-IFN plus RBV treatment can reduce 12% of recurrence rate in 5 years (64% vs 52%) after curative resection of HCC. However, only selected patients are eligible and tolerable to IFN-based treatment after surgical resection and the sustained virological response varied.\n\nHarvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR and being recommended by AASLD and EASL. All-oral regimen, being more tolerable and effective for HCC patients after curative treatment than IFN-based treatment. Mixed HCV genotype infection accounts for 10% of CHC patients in Taiwan. Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi plus rivavirin in the treatment of genotype 2 HCV, as well as mixed genotype 1 and 2 HCV infection. As genotype 1 and 2 are the leading HCV genotypes in Taiwan, It can simplify the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin, not only for genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection. Although an unexpected high recurrence rate in HCC patients under DAA treatment was reported once. However, one recent study showed a low risk of HCC recurrence after DAA treatment. Harvoni is an all-oral regimen, being more tolerable and effective for HCC patients after surgery than IFN-based treatment. The all oral regimen would be beneficial in eradicating HCV viral load and subsequently reduce the risk of recurrence after curative resection of HCV-HCC.\n\nIn this study, the investigators plan to enroll 130 HCV-HCC patients after confirming curative treatment for their HCC, either by surgery or RFA. For the cases fulfilling the inclusion/exclusion criteria, a 12 weeks Harvoni plus ribavirin treatment will be provided for all cases (single armed design). The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years. The secondary objectives of the study are SVR 4/12/24 by DAA, regression of fibrosis, incidence of liver-related complications (EV bleeding, ascites) after DAA treatment, and overall survival for 5 years.\n\nA hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei Veterans General Hospital and Investigated Sites will be recruited as historical controls. The historical controls include HCV-HCC undergoing curative treatment without Peg-interferon plus ribavirin treatment (cohort 1) or with Peg-interferon plus ribavirin treatment (cohort 2) after curative treatment (surgical resection or RFA) for HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anti-HCV positive and HBsAg-negative\n* HCV genotype 1 or 2 infection, mixed infection GT 1 \\& 2 is allowed\n* HCV RNA ≥ 10,000 IU/ml at the time of screening\n* Age \\> 20 y/o\n* BCLC stage 0 or A HCC confirmed by pathology and receiving the first time of curative treatment\n* No recurrence of HCC confirmed by contrast-enhanced image studies (CT or MRI) within 3 months post the curative treatment.\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0-1\n* Child-Pugh score ≤7\n\nExclusion Criteria:\n\n* HBV, or HIV coinfection\n* Co-existing other malignancy\n* Intolerance to ribavirin\n* Marked decompensated liver cirrhosis (CTP score\\>7)\n* Uremia or renal impaired patients (eGFR\\<30)'}, 'identificationModule': {'nctId': 'NCT02959359', 'briefTitle': 'DAA in the Risk of Recurrence After Curative Treatment of HCC', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'The Role of DAA in Reducing the Risk of Recurrence After Curative Treatment of HCC in Patients With Chronic Hepatitis C and Early Stage HCC', 'orgStudyIdInfo': {'id': 'GILEAD IN-US-337-4109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DAA treatment arm', 'description': "Active DAA treatment ('Ledipasvir 90mg/Sofosbuvir 400 mg plus Ribavirin' ) for HCV-HCC patients after curative resection or ablation.", 'interventionNames': ['Drug: Ledipasvir 90mg/Sofosbuvir 400 mg', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Ledipasvir 90mg/Sofosbuvir 400 mg', 'type': 'DRUG', 'otherNames': ['DAA'], 'description': 'A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.', 'armGroupLabels': ['DAA treatment arm']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['rebetol'], 'description': 'A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.', 'armGroupLabels': ['DAA treatment arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yi-Hsiang Huang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, {'name': 'China Medical University Hospital', 'class': 'OTHER'}, {'name': 'Chi Mei Medical Hospital', 'class': 'OTHER'}, {'name': 'Chiayi Christian Hospital', 'class': 'OTHER'}, {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Yi-Hsiang Huang', 'investigatorFullName': 'vghtpe user', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}