NCT04264962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for early_phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2017

Longer than P75 for early_phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

4.2 years

First QC Date

February 9, 2020

Last Update Submit

October 10, 2021

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrance rate

    1 year

Secondary Outcomes (2)

  • Objective response rate

    1 year

  • quality of life (QOL) questionnaire

    1 year

Study Arms (2)

Yang Yin Fu Zheng Jie Du therapy

EXPERIMENTAL
Drug: Yang Yin Fu Zheng Jie Du therapyOther: Routine medical care

Routine medical care

PLACEBO COMPARATOR
Other: Routine medical care

Interventions

Yang Yin Fu Zheng Jie Du therapyDRUG

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

Yang Yin Fu Zheng Jie Du therapy
Routine medical careOTHER

Routine medical care

Routine medical careYang Yin Fu Zheng Jie Du therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhiyun Yang

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver 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

February 9, 2020

First Posted

February 11, 2020

Study Start

January 1, 2017

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations

CN(1)