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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oligo Fucoidan
Placebo
Sponsored by
Hi-Q Marine Biotech International, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Hepatocellular Carcinoma focused on measuring Oligo Fucoidan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment & Oligo Fucoidan

Treatment & Placebo

Arm Description

4.4 g Oligo Fucoidan powder by six months, BID

4.4 g Placebo powder by six months, BID

Outcomes

Primary Outcome Measures

Disease Control Rate
Disease Control Rate will be evaluated by RECIST version 1.1

Secondary Outcome Measures

Objective Response Rate
Objective Response Rate will be evaluated using measurements according to RECISTversion 1.1
Overall Survival Rate
Overall Survival Rate will be evaluated using measurements according to RECIST version 1.1
Progression Free Survival
Progression Free Survival will be evaluated using measurements according to RECIST version 1.1
Quality of Life (QoL)
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)

Full Information

First Posted
August 20, 2019
Last Updated
February 8, 2021
Sponsor
Hi-Q Marine Biotech International, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04066660
Brief Title
Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Official Title
Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hi-Q Marine Biotech International, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
Keywords
Oligo Fucoidan

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment & Oligo Fucoidan
Arm Type
Experimental
Arm Description
4.4 g Oligo Fucoidan powder by six months, BID
Arm Title
Treatment & Placebo
Arm Type
Placebo Comparator
Arm Description
4.4 g Placebo powder by six months, BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Oligo Fucoidan
Intervention Description
4.4 g oligo fucoidan powder, oral, BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
4.4 g placebo powder, oral, BID
Primary Outcome Measure Information:
Title
Disease Control Rate
Description
Disease Control Rate will be evaluated by RECIST version 1.1
Time Frame
from Day 1 to end of treatment (4th visit, month 6)
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Objective Response Rate will be evaluated using measurements according to RECISTversion 1.1
Time Frame
Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up
Title
Overall Survival Rate
Description
Overall Survival Rate will be evaluated using measurements according to RECIST version 1.1
Time Frame
Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up
Title
Progression Free Survival
Description
Progression Free Survival will be evaluated using measurements according to RECIST version 1.1
Time Frame
Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up
Title
Quality of Life (QoL)
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)
Time Frame
1st visit to 4th visit (from day 1 to month 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qunyan Yao, PhD
Phone
86-13661696668
Email
yao.qunyan@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xizhong Shen, PhD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qunyan Yao, PhD
First Name & Middle Initial & Last Name & Degree
Xizhong Shen

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28430159
Citation
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):122. doi: 10.3390/md15040122.
Results Reference
result

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

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