Clinical trial NCT04066660: Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Official title: Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advanced Hepatocellular Carcinoma
Keywords: Oligo Fucoidan
Lead sponsor: Hi-Q Marine Biotech International, Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 . 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Disease Control Rate
timeFrame: from Day 1 to end of treatment (4th visit, month 6)
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Screening (baseline), complete of Treatment Phase(month 6)
measure: Quality of Life (QoL)
timeFrame: 1st visit to 4th visit (from day 1 to month 6)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Xizhong Shen, PhD
role: STUDY_DIRECTOR
References: