Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 09/30/2019 |
| Iliyowasilishwa Kwanza: | 08/19/2019 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 08/20/2019 |
| Iliyotumwa Kwanza: | 08/25/2019 |
| Sasisho la Mwisho Liliwasilishwa: | 09/30/2019 |
| Sasisho la Mwisho Lilichapishwa: | 10/02/2019 |
| Tarehe halisi ya kuanza kwa masomo: | 09/30/2019 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 08/30/2021 |
| Tarehe ya Kukamilisha Utafiti: | 12/30/2021 |
Hali au ugonjwa
Uingiliaji / matibabu
Dietary Supplement: Treatment & Oligo Fucoidan
Dietary Supplement: Treatment & Placebo
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Treatment & Oligo Fucoidan 4.4 g Oligo Fucoidan powder by six months, BID | Dietary Supplement: Treatment & 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: Treatment & Placebo 4.4 g placebo powder, oral, BID |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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. |
Matokeo
Hatua za Matokeo ya Msingi
1. Disease Control Rate [from Day 1 to end of treatment (4th visit, month 6)]
Hatua za Matokeo ya Sekondari
1. 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]
2. 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]
3. 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]
4. Quality of Life (QoL) [1st visit to 4th visit (from day 1 to month 6)]
