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

NCT04066660 | Terminated DMC

• 1 other identifier: HiQ-FUCO-003
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Oligo Fucoidan

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate

  Disease Control Rate will be evaluated by mRECIST

  from Day 1 to end of treatment (4th visit, month 6)

Secondary Outcomes (2)

• Objective Response Rate

  Screening (baseline), complete of Treatment Phase(month 6)

• Quality of Life (QoL)

  1st visit to 4th visit (from day 1 to month 6)

Study Arms (2)

Treatment & Oligo Fucoidan

EXPERIMENTAL

4.4 g Oligo Fucoidan powder by six months, BID

Dietary Supplement: Oligo Fucoidan

Treatment & Placebo

PLACEBO COMPARATOR

4.4 g Placebo powder by six months, BID

Dietary Supplement: Placebo

Interventions

Oligo Fucoidan DIETARY_SUPPLEMENT

4.4 g oligo fucoidan powder, oral, BID

Treatment & Oligo Fucoidan

Placebo DIETARY_SUPPLEMENT

4.4 g placebo powder, oral, BID

Treatment & Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hi-Q Marine Biotech International, Ltd.: lead

Study Sites (1)

Fudan University Zhongshan Hospital

Shanghai, China

Location

Study Officials

• Xizhong Shen, PhD

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: October 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)