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

December 8, 2021 updated by: Zhiyun Yang, Beijing Ditan Hospital

Based on the Comprehensive Evaluation System of Platelet Count/Splenic Length-diameter Ratio to Explore the Efficacy of Yang Yin Fu Zheng Jie Du Therapy in Delaying the Progression of HBV Associated Hepatocellular Carcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, Beijing
        • Zhiyun Yang, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Routine medical care
Drug: Routine medical care
Routine medical care
Experimental: Yang Yin Fu Zheng Jie Du therapy
Drug: Yang Yin Fu Zheng Jie Du therapy
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor progression rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete response rate
Time Frame: 1 year
1 year
Overall survival rate
Time Frame: 1 year
1 year
Progression-free survival rate
Time Frame: 1 year
1 year
Median time to tumor progression
Time Frame: 1 year
1 year
the platelet count/splenic length-diameter ratio
Time Frame: 1 year
1 year
quality of life (QOL) questionnaire
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJDH-YZY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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