Clinical trial · Interventional
Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After interim analysis, we planned to recruit 100 participants. However, due to COVID-19 challenges, statistician advised each group needs at least 30 samples (Gay, 1992). The sponsor and team decided to terminate the trial early for valid data.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oligo Fucoidan | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment & Oligo Fucoidan
- description
- 4.4 g Oligo Fucoidan powder by six months, BID
- interventionNames
- Dietary Supplement: Oligo Fucoidan
- type
- PLACEBO_COMPARATOR
- label
- Treatment & Placebo
- description
- 4.4 g Placebo powder by six months, BID
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Disease Control Rate
- timeFrame
- from Day 1 to end of treatment (4th visit, month 6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available