Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-30 @ 7:14 AM
Study NCT ID:
NCT03208335
Status:
UNKNOWN
Last Update Posted:
2017-07-05
First Post:
2017-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)
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': 'D043169', 'term': 'Endostatins'}], 'ancestors': [{'id': 'D043165', 'term': 'Angiostatic Proteins'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043170', 'term': 'Collagen Type XVIII'}, {'id': 'D024041', 'term': 'Non-Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-02', 'studyFirstSubmitDate': '2017-07-02', 'studyFirstSubmitQcDate': '2017-07-02', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progress-free survival(PFS)', 'timeFrame': '18 months', 'description': 'Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'response rate(RR)', 'timeFrame': '18months', 'description': 'CR(complete response)+PR(partial response)'}, {'measure': 'clinical benefit rate(CBR)', 'timeFrame': '24months', 'description': 'CR+PR+SD(stable disease)'}, {'measure': 'overall survival(OS)', 'timeFrame': '36 months', 'description': 'Overall survival was defined as the time from randomization to death from any cause.'}, {'measure': 'adverse event(AE)', 'timeFrame': '36 months', 'description': 'Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause'}, {'measure': 'Quality of life (QOL)', 'timeFrame': '36months', 'description': 'A questionnaire with questions referred to simple assessments of physical abilities'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rh-endostatin', 'radiotherapy'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Preclinical models have shown that anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently. This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy in the treatment of HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed hepatocellular carcinoma,or radiographic indicative HCC with AFP\\>250ug/l\n* Inoperable and untransplantable,Child-pugh score A or B\n* PS score 0-1\n* At least one measurable site(diameter \\>20mm measured by CT or MRI,\\>10mm measured by helical CT scan.\n* No distant metastases\n* Life expectancy longer than 3 months\n* Willingness and ability to comply the study and signed informed consent.\n\nExclusion Criteria:\n\n* Not comply the designed treatment or change to other treatment\n* Miss follow-up visits or have incomplete follow-up data\n* The efficacy will not be assessed if the Patient withdrawal the treatment due to severe adverse events(SAE),but SAE will be recorded.\n* Disease progression\n* Patients request to withdraw\n* Patients with III hematologic or Ⅳ nonhematologic drug related toxicity ,or SAE'}, 'identificationModule': {'nctId': 'NCT03208335', 'briefTitle': 'Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'ChinaPLAGH-HCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rh-endostatin combination', 'description': 'Continuous intravenous pumping (CIP) recombinant human endostatin(rh-endostatin) 30mg/d, from 5 days before radiotherapy,for 7days,21 per cycle.Standard radiotherapy for HCC is conducted concurrently.Those patients will receive 3-5 cycles rh-endostatin after the radiotherapy is finished,4-6 cycles in all.', 'interventionNames': ['Drug: recombinant human endostatin']}], 'interventions': [{'name': 'recombinant human endostatin', 'type': 'DRUG', 'otherNames': ['rh-endostatin'], 'description': "The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.", 'armGroupLabels': ['rh-endostatin combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Li, MD', 'role': 'CONTACT', 'email': 'szy957@aliyun.com', 'phone': '+86 15801570739'}], 'facility': 'Chinese PLA Gereral Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yu Li, MD', 'role': 'CONTACT', 'email': 'szy957@aliyun.com', 'phone': '+86 15801570739'}], 'overallOfficials': [{'name': 'Yu Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China PLA hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director of Department of Radiotherappy', 'investigatorFullName': 'YuLi', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}