Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-03-01 @ 9:57 AM
Study NCT ID:
NCT02796820
Status:
UNKNOWN
Last Update Posted:
2016-06-15
First Post:
2016-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621679', 'term': 'huaier'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The adverse events of Huaier Granule', 'timeFrame': '6 months', 'description': 'The adverse events were evaluated every 2 weeks.The adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0.'}], 'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': '1 year', 'description': 'DFS was defined as the date of definitive surgery until the date of recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'OS was defined as the date of definitive surgery until the date of death or the last follow-up.'}, {'measure': 'Relapse-free survival (RFS)', 'timeFrame': '5 years', 'description': 'RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.'}, {'measure': 'Metastasis-free survival (MFS)', 'timeFrame': '5 years', 'description': 'MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Huaier Granule', 'After radical surgery', 'Prevention of Recurrence and Metastasis', 'Efficacy and safety'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '20718753', 'type': 'RESULT', 'citation': 'Zhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x.'}, {'pmid': '22895629', 'type': 'RESULT', 'citation': 'Wang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8.'}, {'pmid': '23599758', 'type': 'RESULT', 'citation': 'Zhang T, Wang K, Zhang J, Wang X, Chen Z, Ni C, Qiu F, Huang J. Huaier aqueous extract inhibits colorectal cancer stem cell growth partially via downregulation of the Wnt/beta-catenin pathway. Oncol Lett. 2013 Apr;5(4):1171-1176. doi: 10.3892/ol.2013.1145. Epub 2013 Jan 21.'}, {'pmid': '25077927', 'type': 'RESULT', 'citation': 'Wang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, paralleled control clinical study investigating Huaier Granule for prevention of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects volunteer to sign the informed consent;\n* Aged: 18 to 75 years old;\n* Colorectal cancer (AJCC-TNM, Stage Ⅰ, low-risk Stage Ⅱand Stage Ⅲ; Patients with Stage Ⅲ colorectal cancer refuse to postoperative adjuvant chemotherapy);\n* The diagnosis and colorectal cancer has been confirmed by pathological examination after radical surgery;\n* The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT), alkaline phosphatase (ALP)\\< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \\< 1.5 ULN; normal coagulation function;\n* Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): white blood cells count ≥ 3.0×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L;\n* ECOG：0-2 points；\n* No other previous history of malignancy.\n\nExclusion Criteria:\n\n* Multiple primary cancer;\n* Not recover from the colorectal surgery;\n* Presence of organ, bone, or skin metastases;\n* Pregnant or lactating women;\n* Those with active bleeding due to various reasons;\n* Those with HIV infection or AIDS-associated diseases;\n* Those with severe acute and chronic diseases;\n* Those with severe diabetes;\n* Those with serious infectious diseases;\n* Those who can not take drugs by oral route;\n* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;\n* Conditions that are considered not suitable for this study investigators.'}, 'identificationModule': {'nctId': 'NCT02796820', 'briefTitle': 'Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery', 'orgStudyIdInfo': {'id': 'zsly Huaier-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Huaier Granule', 'description': 'Huaier Granule will be administrated from 4 to 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.', 'interventionNames': ['Drug: Huaier Granule']}, {'type': 'NO_INTERVENTION', 'label': 'Regular follow-up observation', 'description': 'Regular follow-up observation after surgery.'}], 'interventions': [{'name': 'Huaier Granule', 'type': 'DRUG', 'otherNames': ['Huaier'], 'description': 'Huaier Granule is continuously taken three times per day, 20g per time.', 'armGroupLabels': ['Huaier Granule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojian Wu, Ph.D.', 'role': 'CONTACT', 'email': 'wuxjian@mail.sysu.edu.cn', 'phone': '+86-13760608396'}], 'facility': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaojian Wu, Ph.D.', 'role': 'CONTACT', 'email': 'wuxjian@mail.sysu.edu.cn', 'phone': '+86-13760608396'}], 'overallOfficials': [{'name': 'Xiaojian Wu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The investigators would like to share the data to the Participating units.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qidong Gaitianli Medicines Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xiaojian Wu', 'investigatorAffiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}}}}