Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Disease Control Rate
研究概览
简要总结
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 advanced hepatocellular carcinoma. The previous study results demonstrate the advantages of Oligo-Fucoidan in improving the disease control rate in metastatic colorectal cancer. The previous study might provide insights into the development of cancer treatments, particularly in the combination of natural or herbal products with chemotarget agents.
详细描述
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 . advanced hepatocellular carcinoma. The previous study results demonstrate the advantages of Oligo-Fucoidan in improving the disease control rate in metastatic colorectal cancer. The previous study might provide insights into the development of cancer treatments, particularly in the combination of natural or herbal products with chemotarget agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •ECOG PS 0-2;
- •Histologically or cytologically documented unresectable HCC;
- •Measurable disease by RECIST criteria;
- •HCC without well control
- •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 ≥ 2,500/µl;
- •ANC ≥ 1,000/µl;
- •Platelets ≥ 50,000/µl;
- •Hb ≥ 8.5 g/dl;
- •Creatinine ≤ 1.5 x ULN; AND
排除标准
- •Metastatic tumors;
- •Prior or concomitant systemic anti-cancer treatment for HCC, including:
- •Systemic chemotherapy (TACE is allowed)
- •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
- •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.
结局指标
主要结局
Disease Control Rate
时间窗: from Day 1 to end of treatment (4th visit, month 6)
Disease Control Rate will be evaluated by mRECIST
次要结局
- Objective Response Rate(Screening (baseline), complete of Treatment Phase(month 6))
- Quality of Life (QoL)(1st visit to 4th visit (from day 1 to month 6))