Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— YYFZTIHBVHCC  

Official title:

Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927626
• Other study ID #: BeijingDH
• Status: Completed
• Phase: Early Phase 1
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2020
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Confirmed of stage HBV-HCC?b??a??b;

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Yang Yin Fu Zheng therapy
Yang Yin Fu Zheng is a Chinese herbal compound.
• Routine medical care
Routine medical care

Locations

Country	Name	City	State
China	Zhiyun Yang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate		2 years
Secondary	Objective response rate		2 years
Secondary	quality of life(QOL)		2 years