Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatoc... | NCT04264962

Studies
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter

NCT04264962

Sponsor

Beijing Ditan Hospital

Status

Completed

Last Update Posted

Oct 12, 2021Actual

Enrollment

300Actual

Phase

Early Phase 1

Conditions

Hepatocellular Carcinoma

Interventions

Yang Yin Fu Zheng Jie Du therapy
Routine medical care

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Feb 9, 2020

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 11, 2020Actual

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

Oct 10, 2021

Last Update Posted Date

Oct 12, 2021Actual

Name	Class
Xiyuan Hospital of China Academy of Chinese Medical Sciences	OTHER

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

Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.

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

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Yang Yin Fu Zheng Jie Du therapy	Experimental		Drug: Yang Yin Fu Zheng Jie Du therapy Other: Routine medical care
Routine medical care	Placebo Comparator		Other: Routine medical care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrance rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate		1 year
quality of life (QOL) questionnaire		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet the criteria of hepatocellular carcinoma
Ages Eligible for Study: ≤75 years old;
The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm)
After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)
Surgery cannot be allowed;
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		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