Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score

Gastric Adenocarcinoma Clinical Trial

— ESCOTCMAGCPS  

Official title:

Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score Through Registration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02781285
• Other study ID #: LONGHUA-2016-SH
• Status: Recruiting
• Start date: December 2014
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: zou yu ming, Ma.
• Phone: 15021827856
• Email: zoubush133136[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (10)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Fudan University, RenJi Hospital, Ruijin Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, ShuGuang Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Yunnan Provinical Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation

Yilmaz 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. Epub 2006 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	two years
Secondary	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.	two years
Secondary	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.	two years