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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Hepatocellular Carcinoma
• Intervention / Treatment: Dietary supplement: Oligo Fucoidan; Dietary supplement: Placebo

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 . 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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years;
• ECOG PS 0-2;
• Histologically or cytologically documented unresectable HCC;
• Measurable disease by RECIST criteria;
• HCC without well control
• 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 ≥ 2,500/µl;
• ANC ≥ 1,000/µl;
• Platelets ≥ 50,000/µl;
• Hb ≥ 8.5 g/dl;
• Creatinine ≤ 1.5 x ULN; AND

Exclusion Criteria:

• Metastatic tumors;
• Prior or concomitant systemic anti-cancer treatment for HCC, including:
• Systemic chemotherapy (TACE is allowed)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate	Disease Control Rate will be evaluated by mRECIST	from Day 1 to end of treatment (4th visit, month 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1st visit to 4th visit (from day 1 to month 6)
Objective Response Rate	Objective Response Rate will be evaluated using measurements according to mRECIST	Screening (baseline), complete of Treatment Phase(month 6)

Collaborators and Investigators

• Sponsor: Hi-Q Marine Biotech International, Ltd.
• Investigators: Study Director: Xizhong Shen, PhD, Shanghai Zhongshan Hospital

Publications and helpful links

General 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):122. doi: 10.3390/md15040122.

Helpful Links

• Fudan University Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Oligo Fucoidan
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Antineoplastic Agents; Gastrointestinal Agents; Anticoagulants; Anti-Ulcer Agents; Fucoidan
• Other Study ID Numbers: HiQ-FUCO-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No