Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:32 AM
Study NCT ID:
NCT04066660
Status:
TERMINATED
Last Update Posted:
2025-01-13
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'whyStopped': 'After interim analysis, we planned to recruit 100 participants. However, due to COVID-19 challenges, statistician advised each group needs at least 30 samples (Gay, 1992). The sponsor and team decided to terminate the trial early for valid data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Control Rate', 'timeFrame': 'from Day 1 to end of treatment (4th visit, month 6)', 'description': 'Disease Control Rate will be evaluated by mRECIST'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Screening (baseline), complete of Treatment Phase(month 6)', 'description': 'Objective Response Rate will be evaluated using measurements according to mRECIST'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': '1st visit to 4th visit (from day 1 to month 6)', 'description': 'Quality of Life will be evaluated by questionnaire based on EORTC-QLQ30, specific questions evaluated by scores from 1 (not at all), 2 (a little), 3 (quite a bit), 4 (very much); overall healthy and quality of life will be evalauted by scores from 1 (very poor) to 7 (excellent)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oligo Fucoidan'], 'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, controlled trial was conducted evaluating the efficacy of Oligo-Fucoidan with the molecular weight ranged from 500 to 800 Da. as a supplemental therapy in patients with advanced hepatocellular carcinoma. The previous study results demonstrate the advantages of Oligo-Fucoidan in improving the disease control rate in metastatic colorectal cancer. The previous study might provide insights into the development of cancer treatments, particularly in the combination of natural or herbal products with chemotarget agents.', 'detailedDescription': 'Oligo-Fucoidan, a heparin-like molecule with high percentages of L-fucose and sulfated ester groups and low percentages of D-xylose, D-galactose, D-mannose, and glucuronic acid, was present in the cell wall matrix of brown seaweed. Brown seaweed Oligo-Fucoidan was reported to demonstrate various biological activities such as antioxidant, anti-inflammatory, antiproliferative, and proapoptotic activities. Oligo-Fucoidan was also revealed to inhibit the growth of breast and lung cancers in animal models. Oligo-Fucoidan treatment induces the degradation of transforming growth factor (TGF)-β receptor and the consequent inhibition of the epithelial-mesenchymal transition (EMT) in cancer cells. In addition to these molecular mechanisms, it is imperative to investigate the potential of Oligo-Fucoidan as a miRNA regulator for breast cancer treatment and thus delineate the molecular mechanisms underlying the anticancer effects of Oligo-Fucoidan. A randomized, double-blind, controlled trial was conducted evaluating the efficacy of Oligo-Fucoidan with the molecular weight ranged from 500 to 800 Da. as a supplemental therapy in patients with . advanced hepatocellular carcinoma. The previous study results demonstrate the advantages of Oligo-Fucoidan in improving the disease control rate in metastatic colorectal cancer. The previous study might provide insights into the development of cancer treatments, particularly in the combination of natural or herbal products with chemotarget agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years;\n* ECOG PS 0-2;\n* Histologically or cytologically documented unresectable HCC;\n* Measurable disease by RECIST criteria;\n* HCC without well control\n* Child-Pugh A-B\n* Albumin ≥ 2.8 g/dl;\n* Serum total bilirubin ≤ 3 mg/dl;\n* INR ≤ 2.3 or PT ≤ 6 seconds above control;\n* WBC ≥ 2,500/µl;\n* ANC ≥ 1,000/µl;\n* Platelets ≥ 50,000/µl;\n* Hb ≥ 8.5 g/dl;\n* Creatinine ≤ 1.5 x ULN; AND\n\nExclusion Criteria:\n\n* Metastatic tumors;\n* Prior or concomitant systemic anti-cancer treatment for HCC, including:\n* Systemic chemotherapy (TACE is allowed)\n* Investigational anti-cancer agents\n* Severe and/or uncontrolled medical conditions:\n* Uncontrolled high blood pressure\n* History of poor compliance with anti-hypertensive agents\n* Active or uncontrolled infection\n* Unstable angina\n* CHF\n* MI or CVA \\< 6 months\n* GI bleeding \\< 30 days\n* Unable to take oral medications\n* Severe renal impairment which requires dialysis; proteinuria \\> grade 2;\n* BMT or stem cell rescue \\< 4 months; organ transplant;\n* HIV infection;\n* Major surgical procedure, open biopsy, or significant traumatic injury \\< 4 weeks or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 2 weeks;\n* Patients taking narrow therapeutic index medications will be monitored closely. These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine, and digoxin.'}, 'identificationModule': {'nctId': 'NCT04066660', 'briefTitle': 'Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hi-Q Marine Biotech International, Ltd.'}, 'officialTitle': 'Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'HiQ-FUCO-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment & Oligo Fucoidan', 'description': '4.4 g Oligo Fucoidan powder by six months, BID', 'interventionNames': ['Dietary Supplement: Oligo Fucoidan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment & Placebo', 'description': '4.4 g Placebo powder by six months, BID', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Oligo Fucoidan', 'type': 'DIETARY_SUPPLEMENT', 'description': '4.4 g oligo fucoidan powder, oral, BID', 'armGroupLabels': ['Treatment & Oligo Fucoidan']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '4.4 g placebo powder, oral, BID', 'armGroupLabels': ['Treatment & Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xizhong Shen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hi-Q Marine Biotech International, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}