CClinicalTrials.gg
Status unknownNCT05154812Updated Dec 13, 2021

Yang Yin Fu Zheng Jie Du Therapy in HBV Associated Hepatocellular Carcinoma Based on the Platelet Count/Splenic Length-Diameter Ratio

An Early Phase 1 interventional study of Yang Yin Fu Zheng Jie Du therapy and Routine medical care in Hepatocellular Carcinoma, sponsored by Beijing Ditan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-13.

Sponsored by Beijing Ditan Hospital · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2020, registered Dec 2021).
Phase
Early Phase 1
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV associated Hepatocellular Carcinoma based on the platelet count/splenic length-diameter ratio.The purpose of this study is to establish the efficacy evaluation system combined with platelet/splenic length-diameter ratio, and to clarify the effect of this method on relieving hepatitis B cirrhosis and delaying the progression of Hepatocellular Carcinoma.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 108 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Beijing Ditan Hospital is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Meet the criteria of hepatocellular carcinoma Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months Liver function grade child-Pugh A/B Patients who have agreed to select local treatment according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2017) TCM syndrome differentiation belongs to deficiency of qi and Yin, stasis and toxin accumulation syndrom Informed consent from the patient.

Exclusion criteria

Exclusion Criteria:

Patient with other hepatitis virus infections or alcoholic liver, autoimmunity liver, primary biliary cirrhosis, genetic metabolic liver disease, and previous liver transplantation; Serious problem of heart, lung, brain, blood and other important organs; Patients with metastatic liver cancer; Pregnant or child breast feeding women; Mental or cognitive disorders; Who are allergic to the study drug.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    Yang Yin Fu Zheng Jie Du therapy

    Drug: Yang Yin Fu Zheng Jie Du therapy

  • Placebo comparator
    Routine medical care

    Drug: Routine medical care

Interventions

  • DrugYang Yin Fu Zheng Jie Du therapy

    Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.

  • DrugRoutine medical care

    Routine medical care

06

What researchers measure

Primary outcomes

  1. Tumor progression rate

    Time frame: 1 year

Secondary outcomes

  1. Overall survival rate

    Time frame: 1 year

  2. Progression-free survival rate

    Time frame: 1 year

  3. Median time to tumor progression

    Time frame: 1 year

  4. Complete response rate

    Time frame: 1 year

  5. the platelet count/splenic length-diameter ratio

    Time frame: 1 year

  6. quality of life (QOL) questionnaire

    Time frame: 1 year

07

Study locations

1 site
  • Zhiyun Yang, doctor
    Beijing, Beijing Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05154812
Lead sponsor
Beijing Ditan Hospital
Responsible party
Zhiyun Yang (Archiater, Professor, Beijing Ditan Hospital) — Principal investigator
First posted
Dec 13, 2021
Start date
Oct 1, 2020
Primary completion
Sep 30, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Dec 13, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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