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Completed

NCT Number: NCT02927626

Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Zhiyun Yang

Beijing, Beijing Municipality, 100013, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Yang Yin Fu Zheng therapy

Drug

Yang Yin Fu Zheng is a Chinese herbal compound.

Routine medical care

Drug

Routine medical care

Primary outcomes

  1. Survival rate

    Time frame: 2 years

Secondary outcomes

  1. Objective response rate

    Time frame: 2 years

  2. quality of life(QOL)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Beijing Ditan Hospital

Other

Registry information

Official study title

Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment

Acronym: YYFZTIHBVHCC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 7, 2016
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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