Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma (YYFZTIHBVHCC)

July 8, 2020 updated by: Zhiyun Yang, Beijing Ditan Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

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, 100013
        • Zhiyun Yang

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:

  1. Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
  2. Ages Eligible for Study: ≤75 years old;
  3. TCM syndrome is deficiency of both Qi and Yin;
  4. Confirmed of CHB;
  5. Surgery cannot be allowed;
  6. Informed consent from the patient.

Exclusion Criteria:

  1. Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
  2. Serious problem of heart, lung, or kidney with severe dysfunction;
  3. Pregnant or child breast feeding women;
  4. Mental or cognitive disorders;
  5. Participating in other drug trials;
  6. 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
Experimental: Yang Yin Fu Zheng therapy
Drug: Yang Yin Fu Zheng therapy
Yang Yin Fu Zheng is a Chinese herbal compound.
Drug: Routine medical care
Routine medical care
Placebo Comparator: Routine medical care
Drug: Routine medical care
Routine medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: 2 years
2 years
quality of life(QOL)
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Beijing Ditan Hospital

Investigators

  • Principal Investigator: Zhiyun Yang, PhD, 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

August 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 7, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingDH

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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