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Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter (YYFZJDTRHCLT3D)

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Yang Yin Fu Zheng Jie Du therapy
Routine medical care
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;
  • 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.

Sites / Locations

  • Zhiyun Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yang Yin Fu Zheng Jie Du therapy

Routine medical care

Arm Description

Outcomes

Primary Outcome Measures

Recurrance rate

Secondary Outcome Measures

Objective response rate
quality of life (QOL) questionnaire

Full Information

First Posted
February 9, 2020
Last Updated
October 10, 2021
Sponsor
Beijing Ditan Hospital
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04264962
Brief Title
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
Acronym
YYFZJDTRHCLT3D
Official Title
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences

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
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.

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
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yang Yin Fu Zheng Jie Du therapy
Arm Type
Experimental
Arm Title
Routine medical care
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Yang Yin Fu Zheng Jie Du therapy
Intervention Description
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
Intervention Type
Other
Intervention Name(s)
Routine medical care
Intervention Description
Routine medical care
Primary Outcome Measure Information:
Title
Recurrance rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
1 year
Title
quality of life (QOL) questionnaire
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; 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.
Facility Information:
Facility Name
Zhiyun Yang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China

12. IPD Sharing Statement

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

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