Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Disease Control Rate [from Day 1 to end of treatment (4th visit, month 6)]
Disease Control Rate will be evaluated by RECIST version 1.1
Secondary Outcome Measures
- Objective Response Rate [Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up]
Objective Response Rate will be evaluated using measurements according to RECISTversion 1.1
- Overall Survival Rate [Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up]
Overall Survival Rate will be evaluated using measurements according to RECIST version 1.1
- Progression Free Survival [Screening (baseline), complete of Treatment Phase(month 6), and 2 months, 6 months, 12 months and 18 months post-treatment follow up]
Progression Free Survival will be evaluated using measurements according to RECIST version 1.1
- Quality of Life (QoL) [1st visit to 4th visit (from day 1 to month 6)]
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)
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Zhongshan Hospital | Shanghai | China |
Sponsors and Collaborators
- Hi-Q Marine Biotech International, Ltd.
Investigators
- Study Director: Xizhong Shen, PhD, Shanghai Zhongshan Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- HiQ-FUCO-003