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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Dietary Supplement: Oligo Fucoidan Dietary Supplement: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Treatment & Oligo Fucoidan
4.4 g Oligo Fucoidan powder by six months, BID
Dietary Supplement: Oligo Fucoidan
4.4 g oligo fucoidan powder, oral, BID

Placebo Comparator: Treatment & Placebo
4.4 g Placebo powder by six months, BID
Dietary Supplement: Placebo
4.4 g placebo powder, oral, BID




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066660


Contacts
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Contact: Qunyan Yao, PhD 86-13661696668 yao.qunyan@zs-hospital.sh.cn

Locations
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China
Fudan University Zhongshan Hospital Recruiting
Shanghai, China
Contact: Qunyan Yao, PhD         
Principal Investigator: Xizhong Shen         
Sponsors and Collaborators
Hi-Q Marine Biotech International, Ltd.
Investigators
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Study Director: Xizhong Shen, PhD Shanghai Zhongshan Hospital
Additional Information:
Publications of Results:
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Responsible Party: Hi-Q Marine Biotech International, Ltd.
ClinicalTrials.gov Identifier: NCT04066660    
Other Study ID Numbers: HiQ-FUCO-003
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hi-Q Marine Biotech International, Ltd.:
Oligo Fucoidan
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fucoidan
Anti-Ulcer Agents
Gastrointestinal Agents
Anticoagulants
Antineoplastic Agents