Advanced Hepatocellular CarcinomaNCT04066660
Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
A study testing Oligo Fucoidan in people with Advanced Hepatocellular Carcinoma, run by Hi-Q Marine Biotech International, Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Oligo Fucoidan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Oligo Fucoidan, Placebo
- Keywords
- Oligo Fucoidan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligo FucoidanDietary supplement
4.4 g oligo fucoidan powder, oral, BID
PlaceboDietary supplement
4.4 g placebo powder, oral, BID
| Study group | Role | What they receive |
|---|---|---|
| Treatment & Oligo Fucoidan | Experimental | 4.4 g Oligo Fucoidan powder by six months, BID Receives: Dietary Supplement: Oligo Fucoidan |
| Treatment & Placebo | Placebo comparator | 4.4 g Placebo powder by six months, BID Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate
Disease Control Rate will be evaluated by mRECIST
Measured: from Day 1 to end of treatment (4th visit, month 6)
Secondary outcomes (2)
Objective Response Rate
Objective Response Rate will be evaluated using measurements according to mRECIST
Measured: Screening (baseline), complete of Treatment Phase(month 6)
Quality of Life (QoL)
Quality of Life will be evaluated by questionnaire based on EORTC-QLQ30, specific questions evaluated by scores from 1 (not at all), 2 (a little), 3 (quite a bit), 4 (very much); overall healthy and quality of life will be evalauted by scores from 1 (very poor) to 7 (excellent)
Measured: 1st visit to 4th visit (from day 1 to month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hi-Q Marine Biotech International, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xizhong Shen, PhD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066660
- Sponsor's protocol ID
- HiQ-FUCO-003
- Status last verified
- Jan 2025
- First submitted
- 20 Aug 2019
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT04066660
- Acronym / sponsor ID
- HiQ-FUCO-003
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Oligo Fucoidan
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hi-Q Marine Biotech International, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment & Oligo Fucoidan | Experimental | Dietary Supplement: Oligo Fucoidan4.4 g Oligo Fucoidan powder by six months, BID |
| Treatment & Placebo | Placebo comparator | Dietary Supplement: Placebo4.4 g Placebo powder by six months, BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age > 18 years;
- ECOG PS 0-2;
- Histologically or cytologically documented unresectable HCC;
- Measurable disease by RECIST criteria;
- HCC without well control
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligo Fucoidan4.4 g oligo fucoidan powder, oral, BID | Dietary supplement | Treatment & Oligo Fucoidan |
| Placebo4.4 g placebo powder, oral, BID | Dietary supplement | Treatment & Placebo |
Primary outcome
Disease Control Rate
Time frame: from Day 1 to end of treatment (4th visit, month 6)
Disease Control Rate will be evaluated by mRECIST
2 secondary outcomes
Objective Response Rate
Time frame: Screening (baseline), complete of Treatment Phase(month 6)
Quality of Life (QoL)
Time frame: 1st visit to 4th visit (from day 1 to month 6)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xizhong Shen, PhD study director
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligo Fucoidan in people with Advanced Hepatocellular Carcinoma, run by Hi-Q Marine Biotech International, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (time frame: from Day 1 to end of treatment (4th visit, month 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.