Hepatocellular CarcinomaEarly Phase 1YYFZTIHBVHCCNCT02927626
Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma
A Early Phase 1 study testing Yang Yin Fu Zheng therapy and Routine medical care in people with Hepatocellular Carcinoma, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC. 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?
- Yang Yin Fu Zheng therapy and Routine medical care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2018
- 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
- Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
- Ages Eligible for Study: ≤75 years old;
- TCM syndrome is deficiency of both Qi and Yin;
- Confirmed of CHB;
- Surgery cannot be allowed;
- Informed consent from the patient.
Who cannot join
- Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
- 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.
About this study
Official title: Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment
Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Yang Yin Fu Zheng therapy, Routine medical care
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yang Yin Fu Zheng therapyDrug
Yang Yin Fu Zheng is a Chinese herbal compound.
Routine medical careDrug
Routine medical care
| Study group | Role | What they receive |
|---|---|---|
| Yang Yin Fu Zheng therapy | Experimental | Not described Receives: Drug: Yang Yin Fu Zheng therapy; Drug: Routine medical care |
| Routine medical care | Placebo comparator | Not described Receives: Drug: Routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: 2 years
Secondary outcomes (2)
Objective response rate
Measured: 2 years
quality of life(QOL)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018
- Study completionDec 2018
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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyun Yang, Beijing Ditan Hospital
- Investigators
- Zhiyun Yang, PhD, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927626
- Sponsor's protocol ID
- BeijingDH
- Acronym
- YYFZTIHBVHCC
- Status last verified
- Jul 2020
- First submitted
- 6 Oct 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment
- ClinicalTrials.gov ID
- NCT02927626
- Acronym / sponsor ID
- YYFZTIHBVHCC / BeijingDH
- Conditions
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Oct 2016 (estimated)
- 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.
Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yang Yin Fu Zheng therapy | Experimental | Drug: Yang Yin Fu Zheng therapy, Drug: Routine medical care |
| Routine medical care | Placebo comparator | Drug: Routine medical care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
- Ages Eligible for Study: ≤75 years old;
- TCM syndrome is deficiency of both Qi and Yin;
- Confirmed of CHB;
- Surgery cannot be allowed;
Key exclusion criteria (6 listed)
- Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
- 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;
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 |
|---|---|---|
| Yang Yin Fu Zheng therapyYang Yin Fu Zheng is a Chinese herbal compound. | Drug | Yang Yin Fu Zheng therapy |
| Routine medical careRoutine medical care | Drug | Routine medical care, Yang Yin Fu Zheng therapy |
Primary outcome
Survival rate
Time frame: 2 years
2 secondary outcomes
Objective response rate
Time frame: 2 years
quality of life(QOL)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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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.
Zhiyun Yang, PhD principal investigator
Beijing Ditan Hospital
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 Yang Yin Fu Zheng therapy and Routine medical care 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 10 Jul 2020. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival rate (time frame: 2 years). 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 10 Jul 2020.