Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter

Hepatocellular Carcinoma Clinical Trial

— YYFZJDTRHCLT3D  

Official title:

Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264962
• Other study ID #: BeijingDHYZY
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2021
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Meet the criteria of hepatocellular carcinoma

• Ages Eligible for Study: =75 years old;

• The size of the main nodule and multi-centricity (single lesion, three nodules =3 cm)

• After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)

• Surgery cannot be allowed;

• Informed consent from the patient.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Drug:
• Yang Yin Fu Zheng Jie Du therapy
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.

Other:
• Routine medical care
Routine medical care

Locations

Country	Name	City	State
China	Zhiyun Yang	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Ditan Hospital	Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrance rate		1 year
Secondary	Objective response rate		1 year
Secondary	quality of life (QOL) questionnaire		1 year