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

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066660
• Other study ID #: HiQ-FUCO-003
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Hi-Q Marine Biotech International, Ltd.
• Contact: Qunyan Yao, PhD
• Phone: 86-13661696668
• Email: yao.qunyan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Dietary Supplement:
• Oligo Fucoidan
4.4 g oligo fucoidan powder, oral, BID
• Placebo
4.4 g placebo powder, oral, BID

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hi-Q Marine Biotech International, Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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). pii: E122. doi: 10.3390/m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate	Disease Control Rate will be evaluated by RECIST version 1.1	from Day 1 to end of treatment (4th visit, month 6)
Secondary	Objective Response Rate	Objective Response Rate will be evaluated using measurements according to RECISTversion 1.1	Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up
Secondary	Overall Survival Rate	Overall Survival Rate will be evaluated using measurements according to RECIST version 1.1	Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up
Secondary	Progression Free Survival	Progression Free Survival will be evaluated using measurements according to RECIST version 1.1	Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up
Secondary	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)

External Links

•   Fudan University Zhongshan Hospital