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

Sponsor
Beijing Ditan Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05154812
Collaborator
(none)
108
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Yang Yin Fu Zheng Jie Du therapy
  • Drug: Routine medical care
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yang Yin Fu Zheng Jie Du therapy

Drug: Yang Yin Fu Zheng Jie Du therapy
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
Placebo Comparator: Routine medical care

Drug: Routine medical care
Routine medical care

Outcome Measures

Primary Outcome Measures

  1. Tumor progression rate [1 year]

Secondary Outcome Measures

  1. Overall survival rate [1 year]

  2. Progression-free survival rate [1 year]

  3. Median time to tumor progression [1 year]

  4. Complete response rate [1 year]

  5. the platelet count/splenic length-diameter ratio [1 year]

  6. quality of life (QOL) questionnaire [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhiyun Yang, doctor Beijing Beijing China Beijing

Sponsors and Collaborators

  • Beijing Ditan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhiyun Yang, Archiater, Professor, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT05154812
Other Study ID Numbers:
  • BJDH-YZY
First Posted:
Dec 13, 2021
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Dec 13, 2021