Malignant Tumor of Small Intestine Metastatic to LiverPhase 1NCT03189992
Study of TCM Syndrome of Hepatocellular Carcinoma and Colorectal Cancer Based on System Science
A Phase 1 study testing Bushen-Jianpi Dedoction and cinobufotalin injection in people with Malignant Tumor of Small Intestine Metastatic to Liver, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Tumor of Small Intestine Metastatic to Liver
- What is being tested?
- Bushen-Jianpi Dedoction and cinobufotalin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary liver cancer (HCC) and colorectal cancer after surgery.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shang Hai TCM University
Shanghai
shibing su, 021-51323013, shibingsu07@163.com
About this study
Official title: Study of "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" of Primary Hepatocellular Carcinoma and Colorectal Cancer Under the Perspective of System Science
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".
Read the 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
- Being tested
- Bushen-Jianpi Dedoction, cinobufotalin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bushen-Jianpi DedoctionDrug
Also called BSJPD
A traditional chinese medicine prescription
cinobufotalin injectionDrug
Also called CI
an effective Chinese preparation to treat malignant tumor.
| Study group | Role | What they receive |
|---|---|---|
| CC-GSYXZ | Experimental | Colon cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection Receives: Drug: Bushen-Jianpi Dedoction; Drug: cinobufotalin injection |
| CC-WZ | Placebo comparator | Colon cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection Receives: Drug: cinobufotalin injection |
| HCC-GSYXZ | Experimental | Hepatoma cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection. Receives: Drug: Bushen-Jianpi Dedoction; Drug: cinobufotalin injection |
| HCC-WZ | Placebo comparator | Hepatoma cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection Receives: Drug: cinobufotalin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete patient recruitment
Complete transcriptome microarray detection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study startJan 2014
- Primary completionAug 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Tumor of Small Intestine Metastatic to LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shi bing su, PhD, Principal investigator, Shuguang Hospital affiliated with Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189992
- Sponsor's protocol ID
- ShanghaiUTCM
- Status last verified
- Mar 2017
- First submitted
- 4 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wang J, Hu Y, Zhao K, Fan J, Zhu J, Li Q, Chen Q, Lu Y. Comprehensive Analysis of the Expression of Cell Adhesion Molecules Genes in Hepatocellular Carcinoma and their Prognosis, and Biological Significance. Front Biosci (Landmark Ed). 2024 Feb 21;29(2):76. doi: 10.31083/j.fbl2902076.
PubMed 38420809Chen J, Chen QL, Wang WH, Chen XL, Hu XQ, Liang ZQ, Cao YB, Cao YM, Su SB. Prognostic and predictive values of CXCL10 in colorectal cancer. Clin Transl Oncol. 2020 Sep;22(9):1548-1564. doi: 10.1007/s12094-020-02299-6. Epub 2020 Feb 3.
PubMed 32016676Lu Y, Fang Z, Zeng T, Li M, Chen Q, Zhang H, Zhou Q, Hu Y, Chen L, Su S. Chronic hepatitis B: dynamic change in Traditional Chinese Medicine syndrome by dynamic network biomarkers. Chin Med. 2019 Nov 21;14:52. doi: 10.1186/s13020-019-0275-4. eCollection 2019.
PubMed 31768187
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" of Primary Hepatocellular Carcinoma and Colorectal Cancer Under the Perspective of System Science
- ClinicalTrials.gov ID
- NCT03189992
- Acronym / sponsor ID
- ShanghaiUTCM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CC-GSYXZ | Experimental | Drug: Bushen-Jianpi Dedoction, Drug: cinobufotalin injectionColon cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection |
| CC-WZ | Placebo comparator | Drug: cinobufotalin injectionColon cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection |
| HCC-GSYXZ | Experimental | Drug: Bushen-Jianpi Dedoction, Drug: cinobufotalin injectionHepatoma cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection. |
| HCC-WZ | Placebo comparator | Drug: cinobufotalin injectionHepatoma cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of primary liver cancer (HCC) and colorectal cancer after surgery.
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bushen-Jianpi DedoctionAlso: BSJPDA traditional chinese medicine prescription | Drug | CC-GSYXZ, HCC-GSYXZ |
| cinobufotalin injectionAlso: CIan effective Chinese preparation to treat malignant tumor. | Drug | CC-GSYXZ, CC-WZ, HCC-GSYXZ, HCC-WZ |
Primary outcome
Complete patient recruitment
Time frame: 24 months
Complete transcriptome microarray detection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Derived from this study: PubMed 38420809Wang J, Hu Y, Zhao K, Fan J, Zhu J, Li Q, Chen Q, Lu Y. Comprehensive Analysis of the Expression of Cell Adhesion Molecules Genes in Hepatocellular Carcinoma and their Prognosis, and Biological Significance. Front Biosci (Landmark Ed). 2024 Feb 21;29(2):76. doi: 10.31083/j.fbl2902076.
- Derived from this study: PubMed 32016676Chen J, Chen QL, Wang WH, Chen XL, Hu XQ, Liang ZQ, Cao YB, Cao YM, Su SB. Prognostic and predictive values of CXCL10 in colorectal cancer. Clin Transl Oncol. 2020 Sep;22(9):1548-1564. doi: 10.1007/s12094-020-02299-6. Epub 2020 Feb 3.
- Derived from this study: PubMed 31768187Lu Y, Fang Z, Zeng T, Li M, Chen Q, Zhang H, Zhou Q, Hu Y, Chen L, Su S. Chronic hepatitis B: dynamic change in Traditional Chinese Medicine syndrome by dynamic network biomarkers. Chin Med. 2019 Nov 21;14:52. doi: 10.1186/s13020-019-0275-4. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shi bing su, PhD principal investigator
Shuguang Hospital affiliated with Shanghai University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bushen-Jianpi Dedoction and cinobufotalin injection in people with Malignant Tumor of Small Intestine Metastatic to Liver, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shi bing su, Professor (021-51323013, shibingsu07@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete patient recruitment (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189992, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.