Gastric AdenocarcinomaESCOTCMAGCPSNCT02781285
Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score
An observational study of Gastric Adenocarcinoma, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both: both female and male participants are being studied
Who may be able to join
- gastric adenocarcinoma without operation or recurrence after operation or metastasis
- diagnosed within three months
- KPS score≥60
- expected survival time was above 3 months
- HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L
- normal function with heart 、kidney and liver
Who cannot join
- not gastric adenocarcinoma
- simultaneous diagnosis with other malignant tumor
- participate in clinical trials of new drugs not listed in China
- combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital
Shanghai, Shanghai Municipality, 20032
zou yu ming, Ma., 15021827856, zoubush133136@hotmail.com
zhao ai guang, Dr., 13661472241, aiguang@hotmail.com
About this study
Official title: Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score Through Registration
The researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.
Read the detailed description
The purpose of this project is to further evaluate the role of traditional Chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study.
The patients who suffer from advanced gastric cancer often have a very short time survival . Their total survival time is only 4.3 months after the best supportive care. At present palliative chemotherapy is still the main method for advanced gastric cancer .
In recent years, the results of international multi center phase III clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time.
In China, the clinical curative effect of traditional Chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the Traditional Chinese Medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer.
Real World Study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. The observational study of registry (registry study in clinical practice) is particularly widely used.
Clinical practice of traditional Chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. There must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional Chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in China.
- Conditions
- Gastric Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1group one | patients with standard TCM diagnosis and treatment of gastric cancer | |
| 2 group two | patients take Chinese Medicine but not with standard TCM diagnosis and treatment of gastric cancer | |
| 3group three | patients take no Chinese Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influences of traditional Chinese medicine standardized treatment on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score.
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 725 cases .
Measured: two years
Secondary outcomes (2)
The influences of traditional Chinese medicine treatment but with standardization scheme on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score.
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 375 cases.
Measured: two years
The influences of Western Medicine treatment mainly by chemotherapy on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score.
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 400 cases.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startDec 2014
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (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 Gastric AdenocarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, RenJi Hospital, Fudan University, ShuGuang Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Yunnan Provinical Hospital of Traditional Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Shaanxi Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- zhao ai guang, Dr., Principal investigator, Shanghai Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781285
- Sponsor's protocol ID
- LONGHUA-2016-SH
- Acronym
- ESCOTCMAGCPS
- Status last verified
- May 2022
- First submitted
- 15 May 2016
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Yilmaz U, Oztop I, Alacacioglu A, Yaren A, Tarhan O, Somali I. Irinotecan combined with infusional 5-fluorouracil and high-dose leucovorin for the treatment of advanced gastric carcinoma as the first-line chemotherapy. Chemotherapy. 2006;52(5):264-70. doi: 10.1159/000094769. Epub 2006 Jul 26.
PubMed 16873996Cao ND, Zhu XH, Ma FQ, Xu Y, Dong JH, Qin MM, Liu TS, Zhu CC, Guo WJ, Ding HH, Guo YB, Liu LK, Song JJ, Wu JP, Cheng YL, Zeng L, Zhao AG. Chinese Medicine Prolongs Overall Survival of Chinese Patients with Advanced Gastric Cancer: Treatment Pattern and Survival Analysis of a 20-Year Real-World Study. Chin J Integr Med. 2024 Jun;30(6):489-498. doi: 10.1007/s11655-024-4107-8. Epub 2024 May 27.
PubMed 38801641
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score Through Registration
- ClinicalTrials.gov ID
- NCT02781285
- Acronym / sponsor ID
- ESCOTCMAGCPS / LONGHUA-2016-SH
- Conditions
- Gastric Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, RenJi Hospital, Fudan University, ShuGuang Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Yunnan Provinical Hospital of Traditional Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Shaanxi Hospital of Traditional Chinese Medicine
- Study start
- Dec 2014 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 May 2016 (estimated)
- 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.
The researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.
Detailed description
The purpose of this project is to further evaluate the role of traditional Chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study.
The patients who suffer from advanced gastric cancer often have a very short time survival . Their total survival time is only 4.3 months after the best supportive care. At present palliative chemotherapy is still the main method for advanced gastric cancer .
In recent years, the results of international multi center phase III clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time.
In China, the clinical curative effect of traditional Chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the Traditional Chinese Medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer.
Real World Study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. The observational study of registry (registry study in clinical practice) is particularly widely used.
Clinical practice of traditional Chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. There must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional Chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1group one | – | –patients with standard TCM diagnosis and treatment of gastric cancer |
| 2 group two | – | –patients take Chinese Medicine but not with standard TCM diagnosis and treatment of gastric cancer |
| 3group three | – | –patients take no Chinese Medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both: both female and male participants are being studied
Key inclusion criteria (6 listed)
- gastric adenocarcinoma without operation or recurrence after operation or metastasis
- diagnosed within three months
- KPS score≥60
- expected survival time was above 3 months
- HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L
Key exclusion criteria (4 listed)
- not gastric adenocarcinoma
- simultaneous diagnosis with other malignant tumor
- participate in clinical trials of new drugs not listed in China
- combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The influences of traditional Chinese medicine standardized treatment on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score.
Time frame: two years
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 725 cases .
2 secondary outcomes
The influences of traditional Chinese medicine treatment but with standardization scheme on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score.
Time frame: two years
The influences of Western Medicine treatment mainly by chemotherapy on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Background: PubMed 16873996Yilmaz U, Oztop I, Alacacioglu A, Yaren A, Tarhan O, Somali I. Irinotecan combined with infusional 5-fluorouracil and high-dose leucovorin for the treatment of advanced gastric carcinoma as the first-line chemotherapy. Chemotherapy. 2006;52(5):264-70. doi: 10.1159/000094769. Epub 2006 Jul 26.
- Derived from this study: PubMed 38801641Cao ND, Zhu XH, Ma FQ, Xu Y, Dong JH, Qin MM, Liu TS, Zhu CC, Guo WJ, Ding HH, Guo YB, Liu LK, Song JJ, Wu JP, Cheng YL, Zeng L, Zhao AG. Chinese Medicine Prolongs Overall Survival of Chinese Patients with Advanced Gastric Cancer: Treatment Pattern and Survival Analysis of a 20-Year Real-World Study. Chin J Integr Med. 2024 Jun;30(6):489-498. doi: 10.1007/s11655-024-4107-8. Epub 2024 May 27.
- Individual participant dataSharing planned: No
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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.
zhao ai guang, Dr. principal investigator
Shanghai Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma, 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 6 inclusion and 4 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 6 May 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 zou yu ming, Ma. (15021827856, zoubush133136@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influences of traditional Chinese medicine standardized treatment on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. (time frame: two years). 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 NCT02781285, 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 6 May 2022.