Hepatocellular CarcinomaEarly Phase 1YYFZJDTRHCLT3DNCT04264962
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
A Early Phase 1 study testing Yang Yin Fu Zheng Jie Du 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 Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma… 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 Jie Du therapy and Routine medical care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 28 Feb 2021
- 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;
- The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm)
- After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)
- Surgery cannot be allowed;
- 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.
About this study
Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Yang Yin Fu Zheng Jie Du 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 Jie Du therapyDrug
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
Routine medical careOther
Routine medical care
| Study group | Role | What they receive |
|---|---|---|
| Yang Yin Fu Zheng Jie Du therapy | Experimental | Not described Receives: Drug: Yang Yin Fu Zheng Jie Du therapy; Other: Routine medical care |
| Routine medical care | Placebo comparator | Not described Receives: Other: Routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrance rate
Measured: 1 year
Secondary outcomes (2)
Objective response rate
Measured: 1 year
quality of life (QOL) questionnaire
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 posted11 Feb 2020
- Study start1 Jan 2017
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Zhiyun Yang, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264962
- Sponsor's protocol ID
- BeijingDHYZY
- Acronym
- YYFZJDTRHCLT3D
- Status last verified
- Oct 2021
- First submitted
- 9 Feb 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan H, Wang X, Liu X, Yu L, Xie Y, Wu T, Jiang Y, Yang Z. Yangyin Fuzheng Jiedu prescription as an adjunct to minimally invasive treatment in early-stage hepatocellular carcinoma: a randomized controlled trial. Front Pharmacol. 2026 Jul 6;17:1780139. doi: 10.3389/fphar.2026.1780139. eCollection 2026.
PubMed 42518346
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
- ClinicalTrials.gov ID
- NCT04264962
- Acronym / sponsor ID
- YYFZJDTRHCLT3D / BeijingDHYZY
- Conditions
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 Feb 2020 (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.
Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.
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 Jie Du therapy | Experimental | Drug: Yang Yin Fu Zheng Jie Du therapy, Other: Routine medical care |
| Routine medical care | Placebo comparator | Other: 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)
- Meet the criteria of hepatocellular carcinoma
- Ages Eligible for Study: ≤75 years old;
- The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm)
- After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)
- Surgery cannot be allowed;
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 |
|---|---|---|
| Yang Yin Fu Zheng Jie Du therapyYang Yin Fu Zheng Jie Du is a Chinese herbal compound. | Drug | Yang Yin Fu Zheng Jie Du therapy |
| Routine medical careRoutine medical care | Other | Routine medical care, Yang Yin Fu Zheng Jie Du therapy |
Primary outcome
Recurrance rate
Time frame: 1 year
2 secondary outcomes
Objective response rate
Time frame: 1 year
quality of life (QOL) questionnaire
Time frame: 1 year
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 12 Oct 2021.
- Derived from this study: PubMed 42518346Yan H, Wang X, Liu X, Yu L, Xie Y, Wu T, Jiang Y, Yang Z. Yangyin Fuzheng Jiedu prescription as an adjunct to minimally invasive treatment in early-stage hepatocellular carcinoma: a randomized controlled trial. Front Pharmacol. 2026 Jul 6;17:1780139. doi: 10.3389/fphar.2026.1780139. eCollection 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Jie Du 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 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: finished, as of the sponsor's last update on 12 Oct 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. 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?
Recurrance rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264962, which also lists 1 linked publication.
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 12 Oct 2021.