Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-03-02 @ 8:37 PM
Study NCT ID:
NCT02809534
Status:
UNKNOWN
Last Update Posted:
2016-09-07
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Anlotinib in Patients With 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': 'C000625192', 'term': 'anlotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-04', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-week Progression-free survival rate(PFR 12w)', 'timeFrame': 'From randomization，each 42 days up to PD or death(up to 24 months)'}], 'secondaryOutcomes': [{'measure': 'Time to Progression(TTP)', 'timeFrame': 'From randomization，each 42 days up to PD or death(up to 24 months)'}, {'measure': '24-week Progression-free survival rate(PFR 24w)', 'timeFrame': 'From randomization，each 42 days up to PD or death(up to 24 months)'}, {'measure': 'Serum Alpha-Fetoprotein level (AFP)', 'timeFrame': 'From randomization up to 24 months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization until death (up to 24 months)'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'each 42 days up to intolerance the toxicity or PD (up to 24 months)'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'each 42 days up to intolerance the toxicity or PD (up to 24 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anlotinib', 'AL3818'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To assess the primary effects and safety of Anlotinib with placebo in patients with Hepatocellular Carcinoma(HCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of hepatocellular carcinoma who cannot benefit from treatments of ablative therapy\n* Liver function status Child-Pugh Class A or B (score≤8)\n* Enroll 2 group patients：Group A：No history of systematic chemotherapy/target therapy.Group B:Failed with Sorafenib(Last Sorafenib Therapy≥4 weeks )\n* Last Therapy≥4 weeks (such as surgery, PCI,ablation, radiotherapy)，and the wound healing.Patients with adjuvant chemotherapy, last chemotherapy ≥6m\n* At least one measurable lesion (by RECIST1.1)\n* 18-75 years,ECOG PS:0-1,Life expectancy of more than 3 months\n* Main organs function is normal\n* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped\n* Patients should participate in the study voluntarily and sign informed consent\n\nExclusion Criteria:\n\n* Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma\n* History of other malignancy (except for non-melanoma skin cancer, cervix in situ carcinoma)\n* Liver function status Child-Pugh Class C (score\\>9),with malignant ascites\n* HBV-DNA\\>2000IU/mL\n* History of liver transplantation or prepare for it\n* Patients with any severe and/or unable to control diseases，including：\n\n 1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);\n 2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);\n 3. Patients with active or unable to control serious infections;\n 4. Patients with poorly controlled diabetes (fasting blood glucose(FBG)\\>10mmol/L)\n 5. Urine protein ≥ ++，and 24-hour urinary protein excretion\\>1.0 g confirmed\n* Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism\n* Patients with drug abuse history and unable to get rid of or Patients with mental disorders\n* Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage\n* Patients participated in other anticancer drug clinical trials within 4 weeks\n* History of immunodeficiency\n* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment"}, 'identificationModule': {'nctId': 'NCT02809534', 'acronym': 'ALTER0802', 'briefTitle': 'A Study of Anlotinib in Patients With Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Single Group, Open Label, Single-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Hepatocellular Carcinoma (ALTER0802)', 'orgStudyIdInfo': {'id': 'ALTN-08-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anlotinib', 'description': 'Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent', 'interventionNames': ['Drug: Anlotinib']}], 'interventions': [{'name': 'Anlotinib', 'type': 'DRUG', 'description': 'Anlotinib p.o. qd', 'armGroupLabels': ['Anlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aiping Zhou, doctor', 'role': 'CONTACT'}], 'facility': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Aiping Zhou, doctor', 'role': 'CONTACT', 'email': 'zhouap1825@126.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}