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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Yang Yin Fu Zheng therapy
Routine medical care
Sponsored by
Beijing Ditan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhiyun Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yang Yin Fu Zheng therapy

Routine medical care

Arm Description

Outcomes

Primary Outcome Measures

Survival rate

Secondary Outcome Measures

Objective response rate
quality of life(QOL)

Full Information

First Posted
October 6, 2016
Last Updated
July 8, 2020
Sponsor
Beijing Ditan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02927626
Brief Title
Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma
Acronym
YYFZTIHBVHCC
Official Title
Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yang Yin Fu Zheng therapy
Arm Type
Experimental
Arm Title
Routine medical care
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Yang Yin Fu Zheng therapy
Intervention Description
Yang Yin Fu Zheng is a Chinese herbal compound.
Intervention Type
Drug
Intervention Name(s)
Routine medical care
Intervention Description
Routine medical care
Primary Outcome Measure Information:
Title
Survival rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
2 years
Title
quality of life(QOL)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiyun Yang, PhD
Organizational Affiliation
Beijing Ditan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhiyun Yang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100013
Country
China

12. IPD Sharing Statement

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Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma

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