Status:
TERMINATED
Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Hi-Q Marine Biotech International, Ltd.
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 adv...
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 cel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04066660
Start Date
October 1 2019
End Date
July 31 2024
Last Update
January 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Zhongshan Hospital
Shanghai, China