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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    100
  • sponsor
    Hi-Q Marine Biotech International, Ltd.
Updated on 19 February 2021

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)- 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.

Details
Condition Advanced Hepatocellular Carcinoma
Treatment Placebo, Oligo Fucoidan
Clinical Study IdentifierNCT04066660
SponsorHi-Q Marine Biotech International, Ltd.
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Advanced Hepatocellular Carcinoma??
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/l
ANC 1,500/l
Platelets 60,000/l
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note