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Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)

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ClinicalTrials.gov Identifier: NCT04066660
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Hi-Q Marine Biotech International, Ltd.

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
Disease Control Rate [ Time Frame: from Day 1 to end of treatment (4th visit, month 6) ]
Disease Control Rate will be evaluated by RECIST version 1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • Objective Response Rate [ Time Frame: Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up ]
    Objective Response Rate will be evaluated using measurements according to RECISTversion 1.1
  • Overall Survival Rate [ Time Frame: Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up ]
    Overall Survival Rate will be evaluated using measurements according to RECIST version 1.1
  • Progression Free Survival [ Time Frame: Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up ]
    Progression Free Survival will be evaluated using measurements according to RECIST version 1.1
  • Quality of Life (QoL) [ Time Frame: 1st visit to 4th visit (from day 1 to month 6) ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Official Title  ICMJE Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Brief Summary 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 metastatic colorectal cancer. The previous study results demonstrate the advantages of Oligo-Fucoidan in improving the disease control rate. The previous study might provide insights into the development of cancer treatments, particularly in the combination of natural or herbal products with chemotarget agents.
Detailed Description 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 metastatic colorectal cancer. The previous study results demonstrate the advantages of Oligo-Fucoidan in improving the disease control rate. The previous study might provide insights into the development of cancer treatments, particularly in the combination of natural or herbal products with chemotarget agents.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Advanced Hepatocellular Carcinoma
Intervention  ICMJE
  • Dietary Supplement: Oligo Fucoidan
    4.4 g oligo fucoidan powder, oral, BID
  • Dietary Supplement: Placebo
    4.4 g placebo powder, oral, BID
Study Arms  ICMJE
  • Experimental: Treatment & Oligo Fucoidan
    4.4 g Oligo Fucoidan powder by six months, BID
    Intervention: Dietary Supplement: Oligo Fucoidan
  • Placebo Comparator: Treatment & Placebo
    4.4 g Placebo powder by six months, BID
    Intervention: Dietary Supplement: Placebo
Publications * Tsai HL, Tai CJ, Huang CW, Chang FR, Wang JY. Efficacy of Low-Molecular-Weight Fucoidan as a Supplemental Therapy in Metastatic Colorectal Cancer Patients: A Double-Blind Randomized Controlled Trial. Mar Drugs. 2017 Apr 21;15(4). pii: E122. doi: 10.3390/md15040122.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years;
  • ECOG PS 0-2;
  • Histologically or cytologically documented unresectable HCC;
  • Measurable disease by RECIST criteria;
  • Previous local therapy completed > 6 weeks;
  • Any acute toxicity (CTC-AE) < grade 1;
  • Child-Pugh A-B
  • Albumin ≥ 2.8 g/dl;
  • Serum total bilirubin ≤ 3 mg/dl;
  • INR ≤ 2.3 or PT ≤ 6 seconds above control;
  • WBC ≥ 3,000/µl;
  • ANC ≥ 1,500/µl;
  • Platelets ≥ 60,000/µl;
  • Hb ≥ 8.5 g/dl;
  • Creatinine ≤ 1.5 x ULN; AND
  • Amylase and lipase < 1.5 x ULN

Exclusion Criteria:

  • Metastatic tumors;
  • Prior or concomitant systemic anti-cancer treatment for HCC, including:
  • Systemic chemotherapy (TACE is allowed)
  • Immunotherapy
  • Farnesyltransferase inhibitors
  • VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
  • Investigational anti-cancer agents
  • Severe and/or uncontrolled medical conditions:
  • Uncontrolled high blood pressure
  • History of poor compliance with anti-hypertensive agents
  • Active or uncontrolled infection
  • Unstable angina
  • CHF
  • MI or CVA < 6 months
  • GI bleeding < 30 days
  • Unable to take oral medications
  • Severe renal impairment which requires dialysis; proteinuria > grade 2;
  • BMT or stem cell rescue < 4 months; organ transplant;
  • HIV infection;
  • 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;
  • Patients taking narrow therapeutic index medications will be monitored closely. These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine, and digoxin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qunyan Yao, PhD 86-13661696668 yao.qunyan@zs-hospital.sh.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04066660
Other Study ID Numbers  ICMJE HiQ-FUCO-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hi-Q Marine Biotech International, Ltd.
Study Sponsor  ICMJE Hi-Q Marine Biotech International, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xizhong Shen, PhD Shanghai Zhongshan Hospital
PRS Account Hi-Q Marine Biotech International, Ltd.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP