Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe... | NCT05152498

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

NCT05152498

Sponsor

Beijing Ditan Hospital

Status

Unknown status

Last Update Posted

Dec 9, 2021Actual

Enrollment

142Estimated

Phase

Early Phase 1

Conditions

Hepatocellular Carcinoma

Interventions

Fu Zheng Jie Du Hua Yu therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Dec 8, 2021

First Submission Date that Met QC Criteria

Dec 8, 2021

First Posted Date

Dec 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2021

Last Update Posted Date

Dec 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fu Zheng Jie Du Hua Yu therapy	Experimental		Drug: Fu Zheng Jie Du Hua Yu therapy
Routine medical care	Experimental		Drug: Fu Zheng Jie Du Hua Yu therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fu Zheng Jie Du Hua Yu therapy	Drug	Fu Zheng Jie Du Hua Yu is a Chinese herbal compound	Fu Zheng Jie Du Hua Yu therapy Routine medical care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Progression		1 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival		1 year
progression-free survival		1 year
complete response

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhiyun Yang	Recruiting	Beijing	Beijing Municipality	100015	China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided