NCT02927626

Brief Summary

Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P75+ for early_phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

October 6, 2016

Last Update Submit

July 8, 2020

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    2 years

Secondary Outcomes (2)

  • Objective response rate

    2 years

  • quality of life(QOL)

    2 years

Study Arms (2)

Yang Yin Fu Zheng therapy

EXPERIMENTAL
Drug: Yang Yin Fu Zheng therapyDrug: Routine medical care

Routine medical care

PLACEBO COMPARATOR
Drug: Routine medical care

Interventions

Yang Yin Fu Zheng therapyDRUG

Yang Yin Fu Zheng is a Chinese herbal compound.

Yang Yin Fu Zheng therapy
Routine medical careDRUG

Routine medical care

Routine medical careYang Yin Fu Zheng therapy

Eligibility Criteria

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

You may qualify if:

  • Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
  • Ages Eligible for Study: ≤75 years old;
  • TCM syndrome is deficiency of both Qi and Yin;
  • Confirmed of CHB;
  • Surgery cannot be allowed;
  • Informed consent from the patient.

You may not qualify if:

  • Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
  • 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, 100013, 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 Officials

  • Zhiyun Yang, PhD

    Beijing Ditan Hospital

    PRINCIPAL INVESTIGATOR

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

October 6, 2016

First Posted

October 7, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

CN(1)