Hepatocellular CarcinomaEarly Phase 1NCT05152498
Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe HBV Related Hepatocellular Carcinoma (FZJDHYPFTOSHBVHCC)
A Early Phase 1 study testing Fu Zheng Jie Du Hua Yu therapy in people with Hepatocellular Carcinoma, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
The treatment of HBV related hepatocellular carcinoma has always been a worldwide problem. The aim of this study is to alleviate the progression of hepatitis B related hepatocellular carcinoma by the Chinese medicine "Fu Zheng Jie Du Hua Yu" Principle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Fu Zheng Jie Du Hua Yu therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Early Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the criteria of hepatocellular carcinoma
- Ages Eligible for Study: ≤75 years old;
- Informed consent from the patient.
Who cannot join
- Serious problem of heart, lung, or kidney with severe dysfunction;
- Pregnant or child breast feeding women;
- Mental or cognitive disorders;
- Participating in other drug trials;
- Who are allergic to the study drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhiyun Yang
Beijing, Beijing Municipality, 100015
Zhiyun Yang, doctor, +8613439696988, yangzhiyun2016@163.com
About this study
Official title: Forming a Comprehensive Treatment Plan for the Treatment of Hepatitis B Virus Related Hepatocellular Carcinoma With the Core Principles of Fuzheng Jiedu Huayu
The treatment of HBV related hepatocellular carcinoma has always been a worldwide problem. The aim of this study is to alleviate the progression of hepatitis B related hepatocellular carcinoma by the Chinese medicine "Fu Zheng Jie Du Hua Yu" Principle.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Fu Zheng Jie Du Hua Yu therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu Zheng Jie Du Hua Yu therapyDrug
Fu Zheng Jie Du Hua Yu is a Chinese herbal compound
| Study group | Role | What they receive |
|---|---|---|
| Fu Zheng Jie Du Hua Yu therapy | Experimental | Not described Receives: Drug: Fu Zheng Jie Du Hua Yu therapy |
| Routine medical care | Experimental | Not described Receives: Drug: Fu Zheng Jie Du Hua Yu therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Measured: 1 year
Secondary outcomes (3)
overall survival
Measured: 1 year
progression-free survival
Measured: 1 year
complete response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyun Yang, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152498
- Sponsor's protocol ID
- BeijingDH-YZY
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forming a Comprehensive Treatment Plan for the Treatment of Hepatitis B Virus Related Hepatocellular Carcinoma With the Core Principles of Fuzheng Jiedu Huayu
- ClinicalTrials.gov ID
- NCT05152498
- Acronym / sponsor ID
- BeijingDH-YZY
- Conditions
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Dec 2021 (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.
The treatment of HBV related hepatocellular carcinoma has always been a worldwide problem. The aim of this study is to alleviate the progression of hepatitis B related hepatocellular carcinoma by the Chinese medicine "Fu Zheng Jie Du Hua Yu" Principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fu Zheng Jie Du Hua Yu therapy | Experimental | Drug: Fu Zheng Jie Du Hua Yu therapy |
| Routine medical care | Experimental | Drug: Fu Zheng Jie Du Hua Yu therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the criteria of hepatocellular carcinoma
- Ages Eligible for Study: ≤75 years old;
- Informed consent from the patient.
Key exclusion criteria (5 listed)
- Serious problem of heart, lung, or kidney with severe dysfunction;
- Pregnant or child breast feeding women;
- Mental or cognitive disorders;
- Participating in other drug trials;
- Who are allergic to the study drug
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 |
|---|---|---|
| Fu Zheng Jie Du Hua Yu therapyFu Zheng Jie Du Hua Yu is a Chinese herbal compound | Drug | Fu Zheng Jie Du Hua Yu therapy, Routine medical care |
Primary outcome
Time to Progression
Time frame: 1 year
3 secondary outcomes
overall survival
Time frame: 1 year
progression-free survival
Time frame: 1 year
complete response
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fu Zheng Jie Du Hua Yu therapy in people with Hepatocellular Carcinoma, run by Beijing Ditan Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression (time frame: 1 year). 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 9 Dec 2021.