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

Early Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Yang Yin Fu Zheng Jie Du therapy; Drug: Routine medical care

• Registration Number: NCT05154812
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Study First Posted: 2021-12-13
• Last Update Posted: 2021-12-13
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yang Yin Fu Zheng Jie Du therapy	Yang Yin Fu Zheng Jie Du therapy	-
Routine medical care	Routine medical care	-

Primary Outcome Measures

Name	Time	Method
Tumor progression rate	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhiyun Yang, doctor; 🇨🇳 Beijing, Beijing, China