Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04042805
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2019-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
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': 'C000632826', 'term': 'sintilimab'}, {'id': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-27', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': "1 year after the last patient's enrollment"}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': "2 years after the last patient's enrollment"}, {'measure': 'Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).', 'timeFrame': "2 years after the last patient's enrollment"}, {'measure': 'Conversion rate to surgery', 'timeFrame': "1 year after the last patient's enrollment", 'description': 'Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment'}, {'measure': 'Tumor mutation burden in association with ORR and survival.', 'timeFrame': "1 year after the last patient's enrollment", 'description': 'It will be performed by NGS.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology\n* Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery\n* No previous systemic anticancer treatment or TACE treatment\n* Age ≥18 years\n* ECOG performance status: 0-1\n* Child Pugh score≤7\n* Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1\n* Life expectancy ≥12 weeks.\n* Patients must be able to understand and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma\n* History of hepatic encephalopathy or liver transplantation\n* Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.\n* Untreated hepatitis infection: HBV DNA\\>2000IU/mlor10000 copy/ml, HCV RNA\\> 1000copy/ml, both HbsAg and anti-HCV body are positive.\n* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.\n* History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity\n* With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable.\n* Evidence of active pulmonary tuberculosis (TB).\n* Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)\n* History of allergic reactions to related drugs\n* Pregnant women, nursing mothers'}, 'identificationModule': {'nctId': 'NCT04042805', 'briefTitle': 'Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study', 'orgStudyIdInfo': {'id': '2019088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sintilimab Plus Lenvatinib', 'description': 'Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \\<60 kg) orally once a day (QD) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.', 'interventionNames': ['Biological: Sintilimab', 'Drug: Lenvatinib']}], 'interventions': [{'name': 'Sintilimab', 'type': 'BIOLOGICAL', 'otherNames': ['IBI308'], 'description': '200mg intravenously every 3 weeks', 'armGroupLabels': ['Sintilimab Plus Lenvatinib']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'description': '12 mg (or 8 mg) once daily (QD) oral dosing.', 'armGroupLabels': ['Sintilimab Plus Lenvatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lijun Wang, Doctor', 'role': 'CONTACT', 'email': 'wanglijun1017@163.com', 'phone': '+8615801154770'}, {'name': 'Baocai Xing, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Baocai Xing, Doctor', 'role': 'CONTACT', 'email': 'xingbaocai88@sina.com', 'phone': '+8613910721238'}], 'overallOfficials': [{'name': 'Baocai Xing, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baocai Xing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Baocai Xing', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}