Back to resultsYang Yin Fu Zheng Jie Du Therapy in HBV Associated Hepatocellular Carcinoma Based on the Platelet Count/Splenic Length-Diameter Ratio
Primary Purpose
Hepatocellular Carcinoma
Status
Active
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Yang Yin Fu Zheng Jie Du therapy
Routine medical care
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Zhiyun Yang, doctor
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Yang Yin Fu Zheng Jie Du therapy
Routine medical care
Arm Description
Outcomes
Primary Outcome Measures
Tumor progression rate
Secondary Outcome Measures
Overall survival rate
Progression-free survival rate
Median time to tumor progression
Complete response rate
the platelet count/splenic length-diameter ratio
quality of life (QOL) questionnaire
Full Information
NCT ID
NCT05154812
First Posted
December 8, 2021
Last Updated
December 8, 2021
Sponsor
Beijing Ditan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05154812
Brief Title
Yang Yin Fu Zheng Jie Du Therapy in HBV Associated Hepatocellular Carcinoma Based on the Platelet Count/Splenic Length-Diameter Ratio
Official Title
Based on the Comprehensive Evaluation System of Platelet Count/Splenic Length-diameter Ratio to Explore the Efficacy of Yang Yin Fu Zheng Jie Du Therapy in Delaying the Progression of HBV Associated Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yang Yin Fu Zheng Jie Du therapy
Arm Type
Experimental
Arm Title
Routine medical care
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Yang Yin Fu Zheng Jie Du therapy
Intervention Description
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
Intervention Type
Drug
Intervention Name(s)
Routine medical care
Intervention Description
Routine medical care
Primary Outcome Measure Information:
Title
Tumor progression rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival rate
Time Frame
1 year
Title
Progression-free survival rate
Time Frame
1 year
Title
Median time to tumor progression
Time Frame
1 year
Title
Complete response rate
Time Frame
1 year
Title
the platelet count/splenic length-diameter ratio
Time Frame
1 year
Title
quality of life (QOL) questionnaire
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Zhiyun Yang, doctor
City
Beijing
State/Province
Beijing
ZIP/Postal Code
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Yang Yin Fu Zheng Jie Du Therapy in HBV Associated Hepatocellular Carcinoma Based on the Platelet Count/Splenic Length-Diameter Ratio
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