Study of TCM Syndrome of Hepatocellular Carcinoma and Colorectal Cancer Based on System Science

Phase 1

• Conditions: Malignant Tumor of Small Intestine Metastatic to Liver
• Interventions: Drug: Bushen-Jianpi Dedoction; Drug: cinobufotalin injection

• Registration Number: NCT03189992
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge, clinical diagnosis and treatment and curative effect evaluation in TCM. "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" is one of the characteristics of TCM syndrome differentiation and treatment.

This study is the "TCM disease syndrome combination" research baced on principles and methods of system biology, which is through acquisition of primary hepatocellular carcinoma (HCC) and colorectal cancer patients with TCM syndrome information, detection of clinical indicators and genomic, proteomic, and metabolites changes, analyzing the correlation between TCM syndromes and biological information, and revealing its biological material characteristics and the molecular mechanisms of "Same TCM Syndrome for Different Diseases";Developing and implementing the program of TCM syndrome differentiation and treatment for HCC and colorectal cancer to evaluate the efficacy of TCM syndrome based-treatment of HCC and colorectal cancer with TCM syndrom scores, clinical and systems biological indicators, quality of life and survival rate, and to revealing the mechanism of the "Same Treatment for Different Diseases".

Detailed Description

Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge, clinical diagnosis and treatment and curative effect evaluation in TCM. "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" is one of the characteristics of TCM syndrome differentiation and treatment.

In this study, the investigators adopted the transcriptome analysis, proteome analysis and metabolic diversity analysis of the patients with different syndromes of liver cancer and colorectal cancer, and integrate omics information, combining macro and micro methods to screen biomarkers of syndromes

Study Timeline

• Study Start: 2014-01
• Status Verified: 2017-03
• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-15
• Last Update Submitted: 2017-06-15
• Study First Posted: 2017-06-16
• Last Update Posted: 2017-06-16
• Primary Completion: 2017-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Clinical diagnosis of primary liver cancer (HCC) and colorectal cancer after surgery.
2. Liver cancer and colorectal cancer liver and kidney yin deficiency and spleen qi deficiency syndrome diagnosis standard : Yin deficiency of liver and kidney and spleen qi deficiency syndrome see hypochondriac pain, waist and knee Limp, fever, night sweats, dry mouth and throat, fatigue, anorexia, abdominal distension after eating more, red or pale tongue, less moss or Light peel, pulse fine.

Exclusion Criteria

(1) there is a serious heart, kidney, and other diseases of the hematopoietic system effect of drug evaluation factors; (2)Mental disorders (3)Digestive tract obstruction; (4) poor compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CC-GSYXZ	Bushen-Jianpi Dedoction	Colon cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection
CC-GSYXZ	cinobufotalin injection	Colon cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection
CC-WZ	cinobufotalin injection	Colon cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection
HCC-GSYXZ	cinobufotalin injection	Hepatoma cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection.
HCC-GSYXZ	Bushen-Jianpi Dedoction	Hepatoma cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection.
HCC-WZ	cinobufotalin injection	Hepatoma cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection

Primary Outcome Measures

Name	Time	Method
Complete patient recruitment	24 months	Complete transcriptome microarray detection

Trial Locations

Locations (1)

Shang Hai TCM University; 🇨🇳 Shanghai, China