Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
关键词
抽象
描述
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.
日期
| 最后验证: | 09/30/2019 |
| 首次提交: | 08/19/2019 |
| 提交的预估入学人数: | 08/20/2019 |
| 首次发布: | 08/25/2019 |
| 上次提交的更新: | 09/30/2019 |
| 最近更新发布: | 10/02/2019 |
| 实际学习开始日期: | 09/30/2019 |
| 预计主要完成日期: | 08/30/2021 |
| 预计完成日期: | 12/30/2021 |
状况或疾病
干预/治疗
Dietary Supplement: Treatment & Oligo Fucoidan
Dietary Supplement: Treatment & Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Disease Control Rate [from Day 1 to end of treatment (4th visit, month 6)]
次要成果指标
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)]
