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

NCT05154812 | Unknown Early Phase 1 DMC

• 1 other identifier: BJDH-YZY
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Tumor progression rate

  1 year

Secondary Outcomes (6)

• Overall survival rate

  1 year

• Progression-free survival rate

  1 year

• Median time to tumor progression

  1 year

• Complete response rate

  1 year

• the platelet count/splenic length-diameter ratio

  1 year

Study Arms (2)

Yang Yin Fu Zheng Jie Du therapy

EXPERIMENTAL

Drug: Yang Yin Fu Zheng Jie Du therapy

Routine medical care

PLACEBO COMPARATOR

Drug: Routine medical care

Interventions

Yang Yin Fu Zheng Jie Du therapy DRUG

Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.

Yang Yin Fu Zheng Jie Du therapy

Routine medical care DRUG

Routine medical care

Routine medical care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Zhiyun Yang, doctor

Beijing, Beijing Municipality, Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Archiater, Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 13, 2021
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

CN (1)