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

Last updated: January 9, 2025
Sponsor: Hi-Q Marine Biotech International, Ltd.
Overall Status: Terminated

Phase

N/A

Condition

Carcinoma

Treatment

Placebo

Oligo Fucoidan

Clinical Study ID

NCT04066660
HiQ-FUCO-003
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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

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 orthose who receive minor surgical procedures (e.g. core biopsy or fine needleaspiration) within 2 weeks;

  • Patients taking narrow therapeutic index medications will be monitored closely.These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital,cyclosporine, and digoxin.

Study Design

Total Participants: 87
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • Fudan University Zhongshan Hospital

    Shanghai,
    China

    Site Not Available

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