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Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe HBV Related Hepatocellular Carcinoma (FZJDHYPFTOSHBVHCC)

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Fu Zheng Jie Du Hua Yu therapy
Sponsored by
Beijing Ditan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet the criteria of hepatocellular carcinoma
  • Ages Eligible for Study: ≤75 years old;
  • 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

Sites / Locations

  • Zhiyun YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fu Zheng Jie Du Hua Yu therapy

Routine medical care

Arm Description

Outcomes

Primary Outcome Measures

Time to Progression

Secondary Outcome Measures

overall survival
progression-free survival
complete response

Full Information

First Posted
December 8, 2021
Last Updated
December 8, 2021
Sponsor
Beijing Ditan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05152498
Brief Title
Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe HBV Related Hepatocellular Carcinoma (FZJDHYPFTOSHBVHCC)
Official Title
Forming a Comprehensive Treatment Plan for the Treatment of Hepatitis B Virus Related Hepatocellular Carcinoma With the Core Principles of Fuzheng Jiedu Huayu
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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
The treatment of HBV related hepatocellular carcinoma has always been a worldwide problem. The aim of this study is to alleviate the progression of hepatitis B related hepatocellular carcinoma by the Chinese medicine "Fu Zheng Jie Du Hua Yu" Principle.

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
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fu Zheng Jie Du Hua Yu therapy
Arm Type
Experimental
Arm Title
Routine medical care
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fu Zheng Jie Du Hua Yu therapy
Intervention Description
Fu Zheng Jie Du Hua Yu is a Chinese herbal compound
Primary Outcome Measure Information:
Title
Time to Progression
Time Frame
1 year
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
Title
progression-free survival
Time Frame
1 year
Title
complete response
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
No
Eligibility Criteria
Inclusion Criteria: Meet the criteria of hepatocellular carcinoma Ages Eligible for Study: ≤75 years old; 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
Facility Information:
Facility Name
Zhiyun Yang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyun Yang, doctor
Phone
+8613439696988
Email
yangzhiyun2016@163.com

12. IPD Sharing Statement

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Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe HBV Related Hepatocellular Carcinoma (FZJDHYPFTOSHBVHCC)

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